Pharmaceutical & Cosmetic Review July 2019 by New Media B2B

July 2019 | Volume 46 | Number 7

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on acceleration & Africa’s challenges in human health

PRESERVATIVES

CAMS & HEALTH SUPPLEMENTS

SUN CARE

Modern ways protect your products

It’s time for a wellness revolution

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Contents SOUTH AFRICAN PHARMACEUTICAL & COSMETIC REVIEW

July 2019 | Volume 46 | Number 7

w w w.pharmacos.co. za

6 NEWS

Mzansi Retail takes SA brands into Africa

Lintec launches oil tolerant label stock

Symrise collaborates with ChemCom

8 PRODUCT NEWS

18 The highs of

cannabis testing 29 SUN CARE

Active ingredients for blue light protection

Dow’s hybrid technology a driver of inclusivity

Croda supports proposed update for safer

10 EVENTS

sunscreens in the US

The ins and outs of thermal ageing

Propak West Africa opens in September

Repair sun damaged skin with Arabian Cotton

Differences between organic and inorganic UV filters

Omya hosts successful oral care event

What’s new in South Africa

13 INDUSTRY TALK

Dosage patents and the ‘obviousness’ argument

16 PHARMA FOCUS: CAMS & HEALTH SUPPLEMENTS

Tracking developments in SA’s CAMs industry

Cannabis testing influx at local laboratory

IMCD markets its nutraceuticals business

22 PRESERVATIVES & ANTI-MICROBIALS

Readily available Triclosan alternative

New, easy to handle liquid blends

Modern beauty product protection

Insight into SCCS’ final opinion on HEBP

30 Hybrid

technology for colour and sun care products

Matcon’s liquid addition system 37 PROCESS & MANUFACTURING TECHNOLOGY

Effective, market ready Triclosan alternative

Small pharma sensor presents safety game changer

Marchesini counts on cosmetics for record growth

Groninger launches its first FlexClean

New liquid addition system from Matcon

41 ASSOCIATION NEWS

Highlights from the Coschem golf day

P C Review | JULY 2019 |

SOUTH AFRICAN PHARMACEUTICAL & COSMETIC REVIEW

From the editor

THE TEAM EDITORIAL

How honest is your brand?

ith the rising demand for

Keeping with the consumer health and

Editor: Abby Vorster +27 (0)11 877 6038 abby.vorster@newmedia.co.za Layout & Design: Andipha Nkoloti Contributors: Tertia Beharie, Suzanne Ellis, Jan Gauczinski, Nicolas Lasbistes, Cezanne Vielkanowitz, Eileen Zhang ADVERTISING Sales Executive: Carla Melless +27 (0)83 260 6060 carla.melless@newmedia.co.za Sales Executive: Anita Raath +27 (0)82 976 6541 anita.raath@newmedia.co.za Sales Executive: Candida Giambo-Kruger +27 (0)71 438 1918 candida.giambo-kruger@newmedia.co.za

transparency in the beauty

wellbeing theme, our pharma focus on

industry, brands need to meet

complementary medicines and health

consumers’ needs to ensure

supplements looks at how everyone, from

Sales Executive: Daleen Filbey +27 (0)83 409 3119 daleen.filbey@newmedia.co.za

they stay relevant. According to a study

the industry and consumers to the economy

INTERNATIONAL SALES

conducted in 2018 by New York’s Fashion

and our government, can benefit from

Institute of Technology, only 30 percent of

this vibrant market. Turn to page 16 now to

Germany/Austria/Switzerland: Eisenacher Medien Erhardt Eisenacher +49 228 249 9860 info@eisenacher-medien.de

consumers surveyed felt they had enough

read about the cannabis craze and testing

information on a product’s ingredients;

developments along with the importance of

42 percent didn’t think brands provide

GMP and the impact of unclear regulations.

enough information on ingredient safety

In the sun care feature on page 29, we

Italy: Ngcombroker Giacomo Rotunno +39 370 101 4694 g.rotunno@ngcombroker.com Taiwan: Ringier Trade Media Sydney Lai +886 4 2329 7318 sydneylai@ringier.com.hk

and more than 60 percent wanted brands to

explore blue light and the effect it has on

identify the sources of their ingredients.

skin, a new hybrid film former for sunscreens

CIRCULATION

and mass market colour cosmetics, a range

need for honesty in the beauty industry,

of active ingredients proven to repair photo-

Circulation Manager: Felicity Garbers +27 (0)21 701 1566 felicity.garbers@newmedia.co.za

more commonly known as clean beauty.

damaged skin and the key differences

PUBLISHING TEAM

The movement is very much about the

between organic and inorganic UV filters.

General Manager: Dev Naidoo

Experts say it’s this ‘mistrust’ driving the

ingredients used in products and not about

Marchesini’s two new acquisitions are

those excluded during formulation design,

highlighted in our section on process and

which was the fixation of the free-from trend.

manufacturing. Turn to page 38 now to find

Preservatives are among the ingredients

out more about how this leading Italian

under the clean beauty spotlight. Although

manufacturer of processing equipment

misunderstood, preservatives and their

is counting on the cosmetics industry for

younger siblings, anti-microbials, are

major growth.

invaluable. To help consumers understand

In the association news, we’ve published

their importance, many suppliers are actively

a fun gallery of Coschem’s golf day. If you

engaging in delivering positive messages

attended the event in May, go to page 41 now

on these ingredients, speaking to the health

and see if your photo has been published.

Production Controller: Mandy Ackerman Art Director: David Kyslinger JOHANNESBURG OFFICE New Media Publishing, Ground floor, Media Park, 69 Kingsway Avenue, Auckland Park, 2092 Tel: +27 (0)11 877 6111, Fax: +27 (0)11 877 6198 POSTAL ADDRESS PO Box 784698, Sandton, Johannesburg, 2146 Published by New Media, a division of Media24 (PTY) Ltd MANAGEMENT TEAM MANAGING DIRECTOR: Aileen Lamb

and wellbeing of consumers. This is evident in our section on preservatives and anti-

Publishing Manager: Natalie Da Silva +27 (0)11 877 6281 natalie.dasilva@newmedia.co.za

COMMERCIAL DIRECTOR: Maria Tiganis

Enjoy the read!

microbials on page 22. In this feature, you’ll

BRAND STRATEGY DIRECTOR: Andrew Nunneley

find out more about a readily available and

CHIEF FINANCIAL OFFICER: Venette Malone

approved Triclosan alternative and gain

HEAD OF HR: Camillah West

insight into taking a modern approach to

CEO: MEDIA24: Ishmet Davidson

product protection.

HEAD OFFICE New Media House, 19 Bree Street, Cape Town 8001 Tel: +27 (0)21 417 1111, Fax: +27 (0)21 417 1112 Email: newmedia@newmedia.co.za PO Box 440, Green Point, Cape Town 8051

EDITORIAL ADVISORY BOARD Past-President, Society of Cosmetic Chemists SA

Prof Dr Aubrey Parsons

John Knowlton

CEO of the Generic and Biosimilar Medicines of Southern Africa

Professor Emeritus, Faculty of Health Sciences, Nelson Mandela University

Vivian Frittelli

Prof N T (Raj) Naidoo

P C Review is the official journal of: CTFA - The Cosmetic, Toiletry & Frangrance Association of South Africa GBM - Generic and Biosimilar Medicines of Southern Africa

Consultant, Cosmetic Solutions

| JULY 2019 | P C Review

COSCHEM - The Society of Cosmetic Chemists of South Africa HPA - The Health Products Association of Southern Africa AMA - The Aerosol Manufacturers’ Association of South Africa

Pharmaceutical Cosmetic Review is published by New Media 11 times a year and circulates to manufacturers, packers and distributors of pharmaceuticals, health products, cosmetics, detergents, soaps, toiletries and allied products. The journal is an up-to-date source of reference for company directors, factory and production managers, marketing executives, engineers, import agents, buyers and research personnel. While precautions have been taken to ensure the accuracy of its contents and information given to readers, neither the editor, publisher, or its agents can accept responsibility for damages or injury which may arise therefrom. All rights reserved. © Pharmaceutical Cosmetic Review. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means, photocopying, electronic, mechanical or otherwise without the prior written permission of the copyright owners. Pharmaceutical Cosmetic Review is printed and bound by CTP Printers - Cape Town. Copyright: all rights reserved. ISSN 0257-8719

Both acquisitions bring complementary, value adding and differentiated analytical, testing and development solutions for all stages of drug development and commercialisation.

NEWS

Aptar acquisitions set to accelerate drug development ON MAY 16, Petronas Chemicals Group (PCG) entered into a sale and purchase agreement to acquire 100 percent of Da Vinci Group BV, the holding company of BRB International BV (BRB). The acquisition is PCG’s first step into speciality chemicals via inorganic growth. PCG recently announced its next chapter of growth, focusing on future strategic positioning venturing into derivatives and speciality chemicals. ‘The acquisition is a strategic entry point for PCG’s specialties portfolio,’ says managing director and CEO, Datuk Sazali Hamzah. ‘It accelerates the realisation of PCG’s vision to create value by diversifying its product portfolio into differentiated and specialty chemicals.’

BRB provides compelling access into the growing business of silicones. The acquisition enables PCG to enhance its competitive position in attractive end-markets such as personal care, construction, paints and coatings, electronics, automotive and healthcare, particularly in the Asia Pacific region. Ralph Pinckaers, CEO of BRB, adds: ‘This is an exciting opportunity in the development of BRB to achieve its goals of becoming a global supplier in silicones. We wanted to ensure our services and product solutions will remain available.’ On completion of the sales and purchase agreement, BRB will become a wholly owned subsidiary of PCG.

Cama aims for 100 Cama Group’s new headquarters in Molteno, based in Italy’s Lombardy region

ACCORDING TO ANNALISA Bellante, the Cama Group has set a target €100 million in turnover for 2020. ‘We have already implemented a strategic corporate business plan to achieve this ambitious goal,’ she comments. Cama predicts a brilliant end to 2019, with a turnover of nearly €90 million, after a strong investment in human resources – 40 percent more than 2017/18. The investment is based on a business plan that leverages a new organisational model focused on developing a ‘sense of ownership’ for managers, coupled with a key evolution in corporate culture, where the ‘employee’ concept transitions to that of a ‘stakeholder’. Its new Molteno complex in Italy is almost complete. This 35 000m² property will be home to a production area and offices spanning more than 25 000m². The ribbon cutting ceremony for the first wing will take place soon, during the European summer, and coincides with an important opportunity for business growth. This is thanks

MZANSI RETAIL TAKES LOCAL BRANDS TO AFRICA A SMALL COLLECTIVE of South African cosmetics

brands introduced in a Duty Free shop in Johannesburg.

brands, Mzansi Retail was developed by a group of local

The brands have also been featured in an in-flight

SMEs that produce cosmetics. They met at BeautyWorld

South African airline magazine and they have secured

Saudi Arabia, on the national pavilion funded by the

orders with Shoprite Kenya,’ says Lorraine Goodman or

Department of Trade & Industry and facilitated by the

Lavendarlane. ‘Our ethos is to be an international trading

Cosmetic Export Council of South Africa, CECOSA.

house firstly for cosmetics and to move into other fields.

The conception of many of these brands is based on personal experiences. Their stories and journeys remain

We are strict about working with brands manufactured in South Africa and whose suppliers are South African.’

close at heart for the brand owners, which is evident

Many of these brands are contributing to creating

in their end products. Although the global cosmetics

employment and some are even instrumental in the

industry is a billion dollar goldmine, South African

development of new businesses and entrepreneurs.

manufacturers are faced with many barriers to meet the

‘Mzansi Retail has provided opportunities to penetrate

market’s needs. Because there is limited support from

international markets through a rather unique group

businesses and buyers, small cosmetics companies find

using a brilliant strategy,’ she adds. ‘As a small business

it difficult to survive. It is also said, big retailers support

and small manufacturer with limitations, its support has

international brands, putting smaller, high quality local

accelerated Lavendarlane’s my growth and development.

brands at a disadvantage.

The collective has added a great deal of knowledge to its

Mzansi Retail maintains high quality standards, by

members, who share information on reputable suppliers

only representing brands that have Good Manufacturing

and how to deal with foreign issues. By supporting locally

Practice, all the relevant certifications for their products,

manufactured products, inevitably we are growing our

an export licence and are registered business holders.

economy and strengthening our currency.’

‘Our recent, successful project saw the Mzansi Retail

| JULY 2019 | P C Review

to Cama’s investments in quality resources, oriented towards its business objectives, and in technical innovation as a result of advancing its R&D capabilities in Industry 4.0. This investment is said to be worth more than five percent of Cama’s annual turnover and includes process virtualisation, engineering, machine commissioning, technological solutions, a new range of ultracompact wrap-around case packing machines and auxiliary innovations in robotics to be unveiled soon. The evolution of the commercial organisation and its specialisation in the confectionery and bakery, coffee, pet food and ice cream markets have seen Cama launch two new divisions. The first is a healthcare, home and personal care division while the second is positioned at the dairy industry. Cama’s executives are looking forward to Interpack 2020, which will be the ideal venue for the group to present its solutions from these new divisions as well as other innovations.

The range of high quality South African cosmetics, now available in Shoprite Kenya

Balance effective disinfection and user acceptability

New oil tolerant labelstock from Lintec

ALTHOUGH IT’S AN employer’s duty to protect the health, safety and welfare of its employees, the use of disinfectants in cleanrooms can present a significant challenge. This is especially true of sporicidal disinfectants, which have a reputation for being aggressive and unpleasant to use. To overcome these challenges, Ecolab Life Sciences has developed an innovative solution – Klercide Sporicidal. This enhanced peroxide provides the perfect balance between greater safety and user acceptability and fast broad spectrum and proactive sporicidal efficacy against bacteria, yeasts and fungi. Its patented formulation works by attacking the microorganism so its outer wall becomes permeable. This allows a much lower 1.5 percent concentration of its active ingredient, Hydrogen Peroxide, to be as equally

IDEAL FOR OILY surfaces and substrates that would typically need to be cleaned before label application, Lintec’s new labelstock range features a strong oilabsorbing adhesive. The range consists of 0T8060 white polypropylene film, 0T5040 white polyester and OT5050 clear polyester film. These options adhere firmly to smooth and textured substrates and can be directly applied, eliminating the need to degrease surfaces before application. This saves considerable production time and cleaning material costs. The range is ideal for general labelling of cosmetics and foods, steel, automobile components and as industrial identification labels. The labelstocks can be printed with conventional ink or thermal transfer ribbon and will remain legible and firmly affixed under all conditions.

Ecolab’s Klercide Sporicidal Enhanced Peroxide has high user acceptance thanks to its minimal odour

effective and faster acting than a standard six percent formulation. The low levels of active ingredient ensure worker exposure limits are unlikely to be exceeded, even when used in large areas, and the risk of corrosion on surfaces and equipment is reduced. Its unique formulation – which is free from aldehyde, chlorine and peracetic acid – is safer for users and the environment. Ecolab's cleanroom products are available in South Africa from Basan.

NEWS

Soichiro Fujinaga, technical manager of Lintec Europe, comments: ‘Within industries such as cosmetics, automobiles and food, it can be difficult for labels to adhere and remain intact on oily products. With the introduction of the oil absorbing labelstock range, we hope to present a simple yet effective solution to this common problem. The innovative oil absorbent qualities of the labelstock provide excellent adhesion to even the greasiest of surfaces that would usually interfere with adhesion.’ Lintec’s new oil absorbing label stock is ideal for labelling oil based cosmetics

Symrise and ChemCom collaborate to combat body odour

The neutralisation of unpleasant odours is a research field of immense relevance to Symrise

WORKING IN COLLABORATION with the Belgian biotech company, ChemCom, Symrise is researching human olfactory receptors. Their aim is to identify and develop aromatic substances that can neutralise unpleasant odours. Symrise already holds a broad range of raw materials encompassing potentially suitable candidates. ChemCom is now supplying the technical possibilities for searching through the Symrise database for substances that block olfactory receptors. Symrise is one of the first companies in the scent industry with the capability to influence the perception

of undesired odours in a targeted manner through receptor interactions. Thanks to many years of research and cooperation with Prof. Dr Hanns Hatt of Ruhr University Bochum, evidence shows odours can also be ‘switched off’ using certain aromatic substances. The global company employs this principle of odour modulation in its Neofresh technology platform, which combats bad odours of all types. For example, Symrise has developed a fragrance that blocks the molecule trimethylamine, which gives off an unpleasant fishy smell, in a targeted manner. To expand the Neofresh platform, Symrise hopes to neutralise additional unpleasant odours at the receptor level. The partnership with ChemCom will help achieve this. The Belgian biotech company is a global leader in research into human olfactory receptors. With its Biological Nose, ChemCom also possesses a technology that can imitate the human sense of smell and facilitate the search for suitable receptor-blockers.

Symrise has a comprehensive range of fragrance raw materials, which could potentially influence odour receptors and block bad odours. ‘The cooperation with ChemCom will help us expand our Neofresh range with specific blockers that efficiently combat bad odours,’ says Dr Marco Singer, head of fragrance performance at Symrise. ‘This is a unique approach and can be combined with our fragrances with outstanding results. We look forward to bringing this new technology to the market and providing consumers with effective odour stopping products.’ Christian Van Osselaer, MD of ChemCom, adds: ‘We are excited about working with a leading company like Symrise. This cooperation brings us closer to consumers and is an opportunity to demonstrate the effectiveness of blockers in comparison to traditional products. Together, Symrise and ChemCom are in a position to reshape an entire category of consumer products worldwide.’

COSMETICS INDUSTRY SUMMIT - 16 & 17 OCTOBER 2019 “Breaking Barriers in Africa” IDC, 19 Fredman Drive, Sandown, Sandton • • • • • •

Bringing together leaders from business and government Stimulating ‘harmonisation’ across the African continent Easing trade within the African continent Local & International presenters Regulatory framework in various African countries Global best practice in the cosmetic and personal care industry

www.ctfa.co.za

P C Review | JULY 2019 |

STREET 1

1 Healing hydrogels for burnt skin Burnshield is a sterile, hydrogel product used for the emergency care of burns and scalds. The new Mundial Hydrogel is a premium packaged range of Burnshield intended for retail markets. The unique formulation helps reduce infection, while the high water content in the gel promotes effective cooling, minimising skin damage. The Mundial Hydrogel Range consists of 125mℓ, spray, 50mℓ squeeze bottle and 25mℓ tube. The Mundial kits consist of an emergency burn pack, travel pack, home/travel burn kit, 100 x 100mm two pack and a burn kit. Consumers can find these products at leading pharmacies, including Clicks and Dischem, and online at Takealot.com.

2 Advanced retinol delivery Delta medical skin care by Optiphi has launched two new serums, Retinol Serum 1 and Retinol Serum 2, featuring three unique retinoids in an advanced delivery system for optimised skin penetration. The unique, internally designed delivery system ensures maximum activity with minimal irritation. Retinol Serum 1 is a rich serum that promises to minimise the signs of ageing. Retinol Serum 2 is a powerful serum formulated with the maximum allowed concentrations of the three unique retinoids. Visit www.deltaskin.com for more information.

3 Hormone-free testosterone boosting serum

AQ Skin Solutions, a division of AQ Therapeutics, has engineered the first testosterone hormone rebalancing serum of its kind. Specially formulated by Dr Al-Qahtani, a professor, scientist and immunologist, Endo-Test works by activating proteins in the body responsible for producing the testosterone hormone. Endo-Test is the first hormone free solution designed for use by both men and women. It works to restore hormonal balance and increase the body’s energy levels. Using a peptide-specific signalling technology, Endo-Test activates the proteins involved in testosterone production, boosting the body’s natural ability to produce this hormone.

4 Traditional & luxurious Developed in Barcelona and produced in South Africa, 365-Skin Workout is Sorbet’s newest skin care offering. The range is divided into four workout stages: warm up, cardio, strength training and cool down, with products formulated with targeted actives that produce visible results. Some of the active ingredients featured in the 365-Skin Workout formulations include Alpine willow herb extract for its ability to prevent oily skin and assist with pore size reduction; Bright 7 complex with its seven different melanin inhibitors that address pigmentation; and Mallow extract for its sensitive skin soothing benefits.

5 Take a sensory journey Specialising in pure and premium spa quality lifestyle amenities, Healing Earth is proud to extend its repertoire of luxury bespoke lifestyle amenities with the Healing Journeys collection. Healing Journeys is born out of the founder of the brand, Elisabeth Brandt’s travels through Africa. The products feature a careful selection of pure aromatherapy oils, such as basil, jasmine and clary sage, blended with natural bases, including argan, jojoba and grape seed oil. Go to www.healingearth.co.za for more info.

| JULY 2019 | P C Review

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September Coschem Scientific Conference & HPCI Expo

4 to 5 September Gallagher Convention Centre, Gauteng www.hpci-events.com/south-africa

CTFA Safety Assessment Seminar 5 September Gallagher Convention Centre, Gauteng www.ctfa.co.za

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EVENTS

West African packaging event keeps on growing Propak West Africa will be bigger and better in 2019 with an additional 25 percent of exhibition space. The organisers have also confirmed Sasol as a Gold Sponsor for this year’s edition.

The company’s wax division develops and produces one of the most comprehensive ranges of mineral oil-based and synthetic paraffin waxes as well as petroleum jellies used in candle manufacturing, personal care and cosmetics products, packaging, pharmaceuticals and other industrial applications. Through its backward integration into Fischer-Tropsch technology,

Scenes from the very successful 2018 edition of Propak West Africa

Propak West Africa has grown by a total of two thirds in just two years

he Landmark Centre in Lagos, Nigeria will open its doors on 17 September for the start of the seventh edition of Propak West

Africa. The show is scheduled to run for three days until 19 September. Having gown consistently year on year since its inception, Propak West Africa has

George Pearson, regional director for

become one of Africa’s largest and most attended exhibitions for packaging, plastics,

Afrocet Montgomery, comments: ‘The

printing and food processing.

additional hall space allocated for 2019

In 2018, Propak West Africa welcomed

means Propak West Africa has grown by

4 265 attendees, marking an astonishing

a total of two thirds in just two years. This,

31 percent increase in visitor numbers from

coupled with the fact that more than

the 2017 show. The size of the show itself

80 percent of the stand space is already

also grew by almost half with the addition

sold for the upcoming exhibition, is evidence

of a third hall. A total of 32 countries were

of the market’s growth and opportunity for

represented by exhibitors and visitors alike,

development in West Africa.’

which saw the show establish itself as a truly international event. Following the enormous success of last

Going for gold Recently announced as the Gold Sponsor of

year’s expo, organisers have decided to

Propak West Africa, Sasol is an international

increase 2019 floorspace by 25 percent to

integrated chemicals and energy company

accommodate the increasing demand

operating in 33 countries. Sasol’s chemicals,

for exhibitor space. Companies already

polymers, solvents and wax divisions market

confirmed to participate are Bobst, Ishida

and supply value-added products and

Europe, PanAsia Tech, Sasol, Snetor, SkySat

services to the global plastics, packaging

and Windmoeller & Hoelscher.

and personal care industries.

Sasol’s wax division provides global markets with a sustainable feedstock solution for manufacturing wax-based products. Sasol exhibited at Propak West Africa for the first time in 2018. Thanks to the show’s success, the company decided to maximise its marketing efforts in West Africa as the Gold Sponsor for 2019.

Next level conference With more than 5 000 visitors expected and over 200 supplier brands on display, this year’s exhibition is set to be the largest Propak West Africa to date. With a number of new exhibitors joining the fold this September, organisers are confident there will be plenty for visitors to see and do. Among the new supplier brands to join the 2019 exhibitor list are Emsur Macdonell, Hosokawa Alpine, Starlinger & Co, BBM, Holland Colours Europe together with Global Polytech Africa, Five Thousand Miles Nigeria, Atlas Copco Nigeria and Zutrad Ventures. Propak West Africa will feature a colocated conference with a programme angled at current industry trends, insight into how to overcome challenges in business and to remain abreast of global developments. With so much happening in the West African packaging, plastics and printing market, it has been said ‘experts from

5 REASONS TO ATTEND PROPAK WEST AFRICA

some of the world’s leading brands will be in attendance to share market insights,

Source new products

opportunities and know-how with the conference audience’. •

Network with industry professionals Meet existing clients and enhance relationships See live equipment and machinery demos Keep up to date with industry trends

| JULY 2019 | P C Review

Visit www.propakwestafrica.com to register as a visitor for Propak West Africa 2019. Companies still wanting to exhibit can also register their interest via the exhibition’s website.

EVENTS

HPCI expo heads to SA this September Positioned as an exclusive exhibition for home and personal care ingredients, HPCI South Africa will take place at Gallagher Convention Centre on 4 and 5 September. The show will be co-located with Coschem’s annual Scientific Conference.

articipants from all over the

Co-located events

continent as well as a global

The Society of Cosmetic

contingency are expected to

Chemists (Coschem’s)

attend the expo. So far Evonik,

scientific conference

DID YOU KNOW?

for cosmetics; attendance registrations will be handled by the CTFA.

It is key for all HPCI Events are regarded worldwide as leading B2B brand owners and communication forums for manufacturers to attend emerging and new markets. this session, to ensure The events include successful expos and conferences they comply with the hosted in Poland, India and proposed regulations Turkey with South Africa and to guarantee the being added to safety of consumers when the list.

Carst & Walker, Vantage Specialty

will bring world-class

Chemicals, Fourchem, Croda, The

scientists and cosmetics

Care Co., Chemgrit, Symrise, Dia-Stron,

industry professionals

Brenntag, Mireuxus, the Department of

together on the African

Trade & Industry, Cosmetic Ingredients,

continent, to share new

Quantum Colours, Ayanda African Oils,

data, ground-breaking

Savannah Fine Chemicals, AMA Labs,

research and innovative

Kaza Oils, Symrise and Millchem have

scientific content on a world-

confirmed their participation in HPCI

class platform. Anyone interested in

assessments will not only be required

South Africa.

registering to attend should contact

for products on the South African

Bridget MacDonald from Coschem.

market, but also for exporting to the EU

According to the organisers, HPCI Events, many more companies have shown

Also taking place during the

interest in exhibiting. Once confirmed, their

conference, the Cosmetic, Toiletries

participation will be announced. Exhibition

& Fragrance Association (CTFA) will

stands are still available; if you’re keen on

host a safety assessment seminar

exhibiting, please contact HPCI Events for

on 5 September. The seminar will be

more information.

centred on the safety assessment

using their products. Safety

where they are already compulsory. •

HPCI Events – www.hpci-events.com

Picture Credits: © edwardderule, Victoria, mimacz / Fotolia.com

P C Review | JULY 2019 |

EVENTS

DID YOU KNOW?

Omya has extensive expertise in high purity natural calcium carbonate and functional ingredients for oral care applications. These ingredients provide gentle cleansing, remineralisation and repair benefits while promoting a whiter appearance of the teeth.

‘The future in oral care is natural’ – Omya The first ever international summit on oral care innovations ended on a high note. The Healthy Bite conference, hosted by Omya in May, in Lucerne, Switzerland, brought together global industry experts, scientific professionals and leaders in market intelligence to discuss new developments in the category. of Intertek Clinical Research

Services in the UK focused on in vitro

environments. The collection has also been uploaded onto the DuPont SafeSPEC personal protective equipment selector tool website, which enables protective apparel users to select the right Tyvek and Tychem garments and gloves needed to safeguard their workers or to protect critical manufacturing processes by limiting contamination. Based on the

mya was inspired to organise

tests as a quick and inexpensive means

risk, the user inputs information into the

the conference based on

to develop more efficient applications

site to find the best protective clothing

the immense demand for

supported by proven claims. Adrien

and gloves for the site or application.

information on innovative

Dromard, consultant at Oral Care

concepts in the field of oral care. Several

Marketing & Technology, reported on

Now an annual event

trends were revealed during the conference.

new technologies and active ingredients

Omya, a global ingredient supplier

In order to be successful in this category,

such as probiotics, immunoglobulins and

represented locally by CJP Chemicals,

future products must combine natural and

remineralisation agents.

received an immensely positive response

sustainable solutions with high efficacy. They

To round off the scientific and

from the delegates who attended its

must be easy to apply and should promote

ingredient focused content, Mintel’s

oral care conference. As a result, the

the health and wellbeing of consumers.

Marta Krawczyk presented a report on

company will host the second edition of

the latest consumer insights and market

the Healthy Bite conference in 2020.

About 50 participants from leading global

Stefan Lander, vice president of

companies, universities and institutions took

trends in oral care. Participants also had

part in the Healthy Bite lectures and a panel

an opportunity to see and experience

consumer goods, group sales and

discussion centred on essential aspects

the new oral care products, technologies

marketing at Omya, comments: ‘Before

for the successful formulation, testing and

and prototypes from Jungbunzlauer and

this, there has never been a meeting

marketing of oral care products.

ICL, companies that both partnered with

point for focused exchange on the latest

Omya on the inaugural event.

findings in the field of additives and

Thought leadership content

ingredients for oral care. We wanted to

Participants included Prof. Dr Pekka

Sustainability breeds success

build a bridge between research and the

Vallittu of the Finnish University of Turku,

The new DuPont Tychem gloves were also

industry. The enormous positive feedback

who presented his findings on the use of

introduced at the event. This collection

we received with this first event confirms

biomaterials for dental treatment and

of gloves will be available in South Africa

we are on the right track.’

care. Dr Andreas Kiesow of the German

in April.

Fraunhofer Institute demonstrated

For updates and more information

The gloves are designed for chemical

on the oral care conference, visit

methods of evaluating solutions for

exposure protection and to help

Omya’s dedicated website for the event,

dentine hypersensitivity. Dr Peter Hall

safeguard workers in hazardous work

healthybite.omya.com. •

Like, follow and start a conversation with us on social media! @PharmaceuticalCosmeticReview @pharmacosreview @SApharmacos

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| JULY 2019 | P C Review

New Media Publishing, Ground Floor, Media Park 69 Kingsway Avenue, Auckland Park, 2029 PO Box 784698, Sandton, 2146 Tel: +27 (0)11 877 6111 Fax: +27 (0)11 877 6198 2018/12/14 09:10

INDUSTRY TALK

Is your future dosage patent vulnerable to 'obviousness'?

Inventing dosage regimes is a crucial and lengthy step in drug development. Patenting dosage is even trickier. Subsequent to the UK Supreme Court’s ruling on the Tadalafil patent, Spoor & Fisher’s Tertia Beharie shares insight into the implications of the obviousness argument on dosage patents.

atent (UK 1173 181) for the drug Tadalafil has been ruled as invalid by the UK Supreme Court, on the basis it lacked an inventive step.

invention is an added benefit in which the claimed innovation is obvious for another purpose • in the case of a dosage patent, there is no

familiar pre-clinical and clinical procedures. It would have been ‘very likely’ the skilled research team would have conducted further testing at lower doses, including five

The patent is owned by ICOS and exclusively

blanket prohibition on such patents when

milligrams, which the experts suggested

licensed to Eli Lilly. Tadalafil (branded as

drafted in the corrected format.

would have been a ‘no brainer’.

CIALIS) is an orally administered drug for treating erectile dysfunction (ED). It works

The obviousness argument

Implications for SA

in a similar way to Pfizer’s blockbuster drug

Considering the 10 steps, the UK Supreme

The patent for Tadalafil has also been

Viagra, but with fewer side effects. UK

Court found the patent ‘obvious’. The

filed in South Africa and is set to expire in

1 173 181 relates to a dosage regime

obviousness argument was based on a

2020. While it’s unlikely the patent will be

for Tadalafil.

prior art patent application (WO 97/03675)

challenged locally, the stringent 10 step

known as Daugan, which disclosed the use

approach might be used as a blueprint

milligrams of Tadalafil up to a maximum total

of Tadalafil for the treatment of ED, giving

and influence South African Courts in

dose of five milligrams per day.

a 50mg dose as a formulation example.

assessing the inventive step for future

The patent claims doses of nought to five

In an attempt to clear the market for their own Tadalafil generic, Actavis and other generic companies brought revocation proceedings against the ICOS/Lilly patent. The case concerns a principle question – how does the test of obviousness apply to a dosage patent? To clarify the theory behind the inventive step, the UK Supreme Court provides guidance in a 10 step approach. The following factors have to be considered in the obviousness assessment: • was it obvious to try

The 10 step approach might be used as a blueprint and influence South African Courts

• was the research routine in nature

dosage patent cases. The judgement also begs the question – when are dosage patents considered inventive? Given the long list of factors a court might consider, it appears a dosage patent could be more vulnerable to an obviousness attack, not just in the UK but worldwide. Dosage patents can still be valid and a worthwhile means of protecting continuing research on a known drug. Yet patent applicants should focus on any unusual features in their research programme and emphasise these

• the burden and cost of the

Daugan specified a Tadalafil dose in the

research programme

range of 0.5 to 800mg per day. Daugan also

• what value judgments would the

provided data for a 50mg Tadalafil dose.

no doubt reconsider their future global

research team have to make

Daugan did not disclose a dose of one to

patent filing strategies for dosage patent

• were there alternative paths

five milligrams per day of Tadalafil as an

applications, as a result of this judgment. •

of research

effective treatment of sexual dysfunction.

• the motivation of the skilled person to

The novelty of the subsequent Tadalafil

undertake certain technical trials • were the results unexpected or surprising – the court did caution that the fact routine

patent in view of Daugan was therefore not at issue. The Court confirmed the skilled team

tests have uncertain results, does not turn

would use routine, established practices

those results into an invention

involved in pharma research, and the

• the need to avoid hindsight – was

Daugan patent would have motivated them

the combination of steps by which

to identify the low dose. The skilled person

the inventor arrived at the invention

generally aims for a dose as low as possible,

ascertained by hindsight knowledge

consistent with effectiveness and with regard

• whether the feature of the claimed

where possible. Multinational pharma companies will

ABOUT THE AUTHOR

Tertia Beharie is a patent attorney and an attorney of the High Court of South Africa. She specialises in filing applications in the chemical, pharma, petrochemical, agrochemical, metallurgical and biochemical fields.

for safety and tolerability, via routine and

P C Review | JULY 2019 |

COMPANY FOCUS

A preferred partner for individual solutions & innovative formulations Kirsch Pharma South Africa is maintaining its excellent reputation as a supplier. The companyâ&#x20AC;&#x2122;s footprint in Africa also continues to grow, thanks to its ability to meet the changing needs of the healthcare, nutrition, biotech and veterinary industries.

Africa is confronted by a heavy burden of communicable and noncommunicable diseases.

According to the World Health Organization, insufficient access to quality medicines continues to hinder universal health coverage on the continent. Another challenge is that some of

| JULY 2019 | P C Review

in improving the health and wellness

the most nutritionally insecure people

of their people with the support of

in the world live in sub-Saharan

companies like Kirsch Pharma

Africa. Despite the staggering levels

South Africa.

of malnutrition and inferior human

All of Kirsch Pharmaâ&#x20AC;&#x2122;s products are completely traceable

Kirsch Pharma is global company

health on the continent, a number of

with worldwide operations, specialising

African countries are making progress

in supplying premium quality raw

COMPANY FOCUS A QUALITY CONSCIOUS BUSINESS

In the past three years, the

technology and ends with the

South African subsidiary has grown

monitoring and certification of its

its market share considerably in

products within its laboratory.

the pharma, infant nutrition and QUALITY IS NOT a fixed status – it requires constant adaptation to the new requirements of customers, the market and the environment. At Kirsch Pharma South Africa, quality means to fulfil the entire requirements of its partners and environment.

The company guarantees strict

food industries by finding the right

conformity with its customers’

balance between local demand

individual requirements as well as

and what it can offer.

compliance with the appropriate

Based in Isando, Gauteng, the

current monographs.

local subsidiary’s success is also

Kirsch Pharma also provides

attributed to its flat organisational

comprehensive product

food and feed industries where the demand for

structure. This approach prompts

documentation to enable

quality is stringent, the company is obliged to offer

the increased involvement

a corresponding quality level.

of all employees in the

Because its customers are from the pharma,

decision-making process. It also materials and formulations according

elevates their level

to individual requirements, for

of responsibility,

the pharmaceutical, nutritional,

improves the speed

biotechnology, veterinary and

of communication

cosmetics industries.

among employees,

Its long standing network of

helping the business

selected co-producers, together

respond quicker to its

with its certified laboratory guarantees

customers’ needs.

customers always receive the quality they need for their specific applications. The company’s inorganic salts and

the business in 2008. Avoiding the typical rigid focus of a

solutions. Ndumiso Mhayisa, business

corporate business, he says it’s

development manager at Kirsch

the company’s individuals who

Pharma South Africa, says the areas

have contributed to its agility and

of human and animal nutrition are

ongoing success. Broschk is not resting on his

documentation and the continual improvement of

An interior view of Kirsch Pharma Healthcare, based in Bissendorf, Germany

and continues to invest heavily in his employees. All 17 of them

customised solutions based on

recently attended neuroscience

research. Kirsch Pharma South Africa is

based excellence training sessions

autonomous and has the capabilities

with a professional, executive and

to customise research based solutions

high performance coach. The

suited to the needs of the African

goal of this training is to enhance

market. We do this by working closely

the interactions within the Kirsch

with our customers and our head office

Pharma South Africa team and to

in Salzgitter, Germany,’ he explains.

move it beyond its current place of excellence.

are the starting point and goal company offers more than 1 000

Exceptional quality standards

different packaging and product

Operating from a place of

combinations ranging from small pack

excellence is the norm for the

sizes up to big bags. In addition, it is

global group. Kirsch Pharma’s

flexible regarding batch sizes.

employees, through their dedication and expertise, ensure

Fluid, flat and successful

its high quality standards are

In October 2018, Kirsch Pharma South

met worldwide.

Africa celebrated its 25th anniversary. It

comprehensive

laurels during this successful phase

challenges in human nutrition need

of Kirsch Pharma’s activities. The

products. It sees its

Pharma South Africa, implemented

in Africa, as well as its animal feed

The individual needs of its customers

and designation of

Hermann Broschk,

a flat structure when he joined

‘African communities facing

necessary classification

managing director of Kirsch

impact in improving human health

the company.

DID YOU KNOW?

Kirsch Pharma HealthCare is now GMP certified. As the newest subsidiary of the global company, in April it was successfully audited by the German authority and gained its manufacturer’s authorisation.

customised blends have immense

both strong pillars of growth for

registration along with the

its work processes as an essential quality factor. On this basis, the processes related to the production and delivery of its products are executed smoothly. All of Kirsch Pharma’s products are also completely traceable. For the pharmaceutical industry, it produces active ingredients and excipient blends for oral and injection applications, including oral rehydration salts, tablets and capsules etc. In the field of special nutrition, it offers ingredients and raw materials for the production of infant nutrition, nutraceuticals and dietary foods.•

This starts with the qualification

is one of five subsidiaries of the Kirsch

of raw materials, extends to

Pharma group with the other four based

sustainable product development

in Spain, China, Singapore and Australia.

with modern production

Kirsch Pharma South Africa – www.kirschpharma.com

P C Review | JULY 2019 |

PHARMA FOCUS//CAMs & Health Supplements

A health revolution where everyone benefits The global CAMs and dietary supplements industry is vibrant, with South Africa in line with the international trend of exhibiting a steady growth pattern. This industry has a significant role to play in well-being and preventative healthcare, substantially reducing individual demands on the country’s public healthcare system. By Suzanne Ellis

he health and wellness trend

a lot at stake and consequently

have to shut down. This could wipe

has taken the world by storm. An

invest a great deal of time, resources

out half of the market!’

increasing number of consumers

and effort to ensure their products

now choose to take responsibility

live up to their reputation.’

for their health, which is having a positive

Ascencao points out, the regulations make compliance very

Yet Ascencao says the South

impact on the Complementary and

African health products industry

Alternative Medicines (CAMs) and health

continues to be pressurised

or dietary supplements (HS) market.

by regulations.

‘The total retail value of the CAMs and HS

‘From 2013 to

market in South Africa is R8 billion,’ states

2017, the HPA was

Bruce Dennison, founder of Natural

involved in extensive

Products Strategic Advice and president

collaboration with

of the Health Products Association of

the DoH and had

Southern Africa (HPA). ‘Of this, dietary

high expectations for

supplements and vitamins are valued at

a positive outcome.

around R5 billion.’

When the General Regulations to the

difficult for many in the industry. They rule out the understanding of food and dietary supplements

DID YOU KNOW?

according to global norms, and the classification of natural health and

South Africa represents nutritional products as about one percent of the total a subset of drugs will world market for CAMs and HS. negatively impact the Dietary supplements in the country recorded 11 percent growth in local industry and 2018, reaching R1.9 billion, and its consumers. vitamins grew by 13 percent ‘The DoH also hasn’t to reach R3 billion. undertaken any impact Source: Euromonitor

The impact of regulations

Medicines and Related

For decades, CAMs and HS were

Substances Act, 101 of 1965

marketed in South Africa without

(Regulations, 2017) were eventually

studies to determine the

risks these regulations pose on the economy and an industry that

government intervention.

published on 25 August

provides employment and promotes

This has changed

2017, the industry was

health and wellness,’ she stresses.

dramatically with strict

dismayed its input had

regulations threatening

not been considered.

to stifle industry growth

These regulations

Crippling healthcare systems need support

and innovation.

effectively defined

Global healthcare systems, South

The HPA, Self-Medication

“CAMs” and “HS” as

Africa’s in particular, are under

Association of South Africa

medicines, with the

immense pressure. As a result,

and the Direct Selling

current regulatory

the potential benefits of food and

Association continue to

framework posing

dietary supplements contributing

work with the South African

a major risk to the

to minimising global healthcare

Department of Health (DoH)

South African industry

costs is being researched by major

in the quest for industry

and consumers,’

organisations. A report by the

appropriate regulations.

she explains.

International Alliance of Dietary

‘The mainstream, responsible HS and CAMs market promotes safe, quality products manufactured and

Maria Ascencao states cannabis is the it raw material in new dietary supplements and cosmeceuticals. It is also included in some of today’s cutting-edge and most promising pharma agents

marketed by law-abiding,

Dennison adds:

Supplement Associations (IADSA),

‘The main inhibiting

entitled Healthcare Cost-Saving

factor of the current

through more widespread use of

regulatory framework

Dietary Supplements, concluded

is no new products

‘a significant body of scientific

can be introduced,

research indicates many conditions

ethical companies committed to

as they have to be registered as

are largely preventable if certain

consumers and their safety,’ says HPA’s

pharmaceuticals. Another grave

nutrients in the diet are consumed

chairlady, Maria Ascencao. ‘Companies

danger is many smaller companies

at sufficient levels to prevent a range

with nationally recognised brands have

will be unable to comply and may

of common health conditions. In

| JULY 2019 | P C Review

PHARMA FOCUS//CAMs & Health Supplements

THE BASICS OF GMP EXPLAINED

Despite unworkable regulations that require all CAMs and HS to be registered as pharmaceuticals, Bruce Dennison says the industry continues to grow at about eight to 10 percent annually

GMP IS A set of quality assurance practices promoted by regulatory authorities, including SAHPRA to ensure manufacturing processes are rigorously set and monitored. These guidelines provide the minimum requirements to be met by a pharma manufacturer. This ensures consistently

certification of products are two quality

high-quality end products, which don’t pose any

standards in CBD cannabidiol that

risks to the public.

consumers should care about.’

In practical terms, GMP for the SA CAMs industry is a set of rules that need to be followed.

A quality conscious market

Retha Conrad, GM at Afriplex, explains: ‘Our

As products flood the market, questions

company follows GMP not only because its

of quality and heavy metal content come

required by SAHPRA, but also as GMP has become an integral part of the culture at Afriplex. Being a third-party contract manufacturer with various Retha Conrad says GMP is primarily the focus on avoiding cross contamination of products, controlling temperature and humidity levels using a HVAC system and the control of production processes using master documents

such cases, food supplements might

clients, ranging from large pharma multinationals to entrepreneur led SMEs, we need to make sure GMP principles add value to our systems.’

to the fore. To meet industry requirements for high quality processing and testing, Afriplex has launched South Africa’s first dedicated cannabis testing laboratory, which meets the DoH and SAHPRA’s requirements. The lab also boasts a specialised team of experts and researchers and has been

offer a straightforward and convenient

The cannabis revolution

nominated by the South African

option. Food supplements provide a safe,

Cannabis has been elevated from

Cannabis Research Institute (SACRI) as

effective and cost-efficient means to

an illegal substance to the venerated

its ‘laboratory of choice’.

deliver real health benefits to citizens of

saviour of the masses. The plant is

all nations and states.’

currently the shining star of botanicals

McMillan, notes ‘within medical

SACRI’s general manager, Lauren

and the market is exploding worldwide as

cannabis, GMP is a huge focus for

A positive end in sight

growers, manufacturers, marketers and

SAHPRA and overseas authorities.

For decades the HPA has been

consumers clamour for a piece of the

In-house testing will become more

negotiating with the DoH for CAMs/HS

lucrative CBD pie.

important for the CAMs industry, based

appropriate regulations. It has been a

A variety of diseases and conditions

on the DoH’s recent Government Notice

long and daunting journey, which may

are reportedly treatable with cannabis,

No. R755 in the Government Gazette

finally produce positive results as the HPA

and research is being conducted on

No. 42477, which allows some CBD-

proceeds with successfully engaging

specific medical formulations for different

containing products, under prescribed

with the South African Health Products

purposes. With recent changes to

restrictions in the notice, to be sold as

Regulatory Authority (SAHPRA).

cannabis legislation, South Africa

health supplements. This makes testing

could become a major provider of

of these active ingredients and final

comprehensive work by the HPA

this ‘green gold’ health boosting

products vital to ensure compliance with

executive council to engage with SAHPRA

commodity and the economic returns

the notice.’

at the highest level, as well as with

could be astronomical.

‘There has been extensive and

other government-aligned bodies and

‘The current trend to reform prohibition

SACRI is Africa’s first Centre of Excellence in the field of cannabis and

business organisations, as part of the

has sparked an unprecedented bull-

cannabinoid therapy management and

strategic lobbying, government liaison

market in all things CBD related,’ states

research, and it’s been working with

and industry alliance plan. This goal has

Ascencao. ‘CBD is proving to be a

Afriplex to test multiple APIs and finished

been underpinned by the HPA’s spirit of

beneficial health supplement. The data

products. The results are interesting –

working towards a structured industry

clearly shows this is one of the fastest

they show not only CBD and THC levels

engagement as a source of strength,

growing markets in the world. The CBD

in the products, but also contaminants

not conflict. The strategy is now coming

industry will need to stay focused on

such as heavy metals and pesticides.

to fruition, and there is an imminent

ethical and quality production. For

McMillan says this is why ‘it’s crucial to

solution to the regulatory quagmire

example, companies who source cheap

build quality within the system and not

imposed by the August 2017 regulations,’

CBD from Asia (both China and India),

simply rubber stamp the end product as

reveals Ascencao. ‘The imminent SAHPRA

risk providing people with contaminated

GMP approved’.

announcement is anticipated to provide

products. This is because soil

the way forward for CAMs/HS. It should

contamination and the use of pesticides

South African cannabis market, which

also address the impending November

is dangerous for the CBD supply chain

could reach an annual value of R27

2019 deadline, which has been a major

and end user. Right now, quality and

billion by 2023, according to a report by

cause for concern.’

purity certification as well as non-GMO

Prohibition Partners. •

Ultimately, it’s all systems go for the

P C Review | JULY 2019 |

PHARMA FOCUS//CAMs & Health Supplements

The highs of cannabis testing The medicinal benefits of cannabis are well known. A brief literature search on the topic uncovers a tsunami of information with claims spanning all major disease groupings. V&M Analytical Toxicology Laboratory Services has seen a significant increase in the number of cannabis related samples submitted for testing. RIGHT

LEFT

Cape. It specialises in chemical analysis and was recently audited by the South African Health Products Regulatory Authority (SAHPRA). Mauritz Wentzel, director of V&M, comments: ‘We have noted a significant increase in the number of cannabis-related samples submitted

for testing. These include powders, lobally there is a strong indication of efforts now implemented in the commercialisation of

The instrument lab (left) and prep lab (right) at V&M Analytical Toxicology Laboratory Services

of a suitable product or supplement is

cannabis, underscored by a recent SABC

likely to be met with very good returns.

news article entitled Cannabis craze

Yet the poor oral bioavailability (six to

weeds out junior mining field.1

19 percent)6,7, largely attributed to high

According to the article, the world’s

lipophilicity, presents a challenge. Recent

top three listed cannabis companies

findings8 that Cmax is increased during fed

– Canopy Growth, Tilray and Aurora

states and in lipid formulations are clues

Cannabis – have a combined market

to be considered when applying new

value of around USD30 billion. This year,

formulation strategies with the end

consumers are expected to spend over

goal of improved bioavailability and

USD7 billion on cannabis products in

product differentiation.

Canada alone, reports Deloitte. The recent Cape Town Cannabis Expo drew 16 500 visitors on its first day.2

Local developments Two recent events have helped unlock the mainstream commercial development of

Clinical targets

cannabis-related products in South Africa.

Over the last 25 years, the

The constitutional court ruling on

endocannabinoid system (ECS)

18 September 2018 effectively

has emerged as an important

decriminalised the use or possession of

neuromodulatory system. ECS is

cannabis by an adult in private.

comprised of cannabinoid receptors,

oils, crude plant extracts and all manner of formulations. Our expertise in the development of high resolution, stability indicating chromatographic methods for complex herbal formulations has helped prepare us for the analysis of cannabis samples. We are able to accurately measure the concentration of various cannabinoids, including CBD and THC, ensuring a product’s compliance (<0.001 percent THC and <0.0075 percent CBD). We can also measure the concentration of various other important plant cannabinoids, including CBDA, CBG, CBGA, CBN, CBDV and CBC.’ The array of analytical instrumentation at the state of the art lab covers the broad spectrum of tests required for effective cannabis testing. This includes HPLCs (cannabinoids and mycotoxins), LC-MS/MS (pesticides), ICP-MS (heavy metals Hg, Cd and Pb), GC-FID/FID (residual solvents) and GC-MS (cannabinoids). •

Thereafter, the former minister of health,

endogenous cannabinoids

Dr Aaron Motsoaledi announced on

(endocannabinoids) and the

15 May that certain preparations

enzymes responsible for the synthesis

containing CBD are now excluded from

and degradation of these.3 The

the provisions of the medicines and related

endocannabinoid anandamide

substances act, 1965 (Act No. 101 of 1965).

has been linked to the so-called

CBD is limited to a maximum daily dose of

‘runners high’, experienced by some

20mg while processed products are only to

4. bjsm.bmj.com/content/38/5/536

endurance athletes.4

contain the naturally occurring quantity of

5. blog.drugbankplus.com/medicinal-marijuana-and-epilepsy

cannabinoids found in the source material

6. Biomed Environ Mass Spectrom. 1986 Feb;13(2):77 to 83

The effects of certain plant-based cannabinoids, THC in particular needs

and not more than 0.001 percent THC or

no introduction. Another is cannabidiol

0.0075 percent total CBD.

(CBD), which on 25 June 2018 became the first CBD based product available on the US Market, as Epidiolex.5

V&M Analytical Toxicology Laboratory

Supplementation with CBD is

Services is a private ISO 17025 testing

on the increase and presentation

To measure is to know

| JULY 2019 | P C Review

laboratory located in George, Western

REFERENCES 1. www.sabcnews.com/sabcnews/cannabis-craze-weeds-outjunior-mining-field 2. www.bizcommunity.com/Event/196/40/59675 3. Hui-Chen Lu, Ken Mackie, An introduction to the endogenous cannabinoid system, Biological Psychiatry, http://dx.doi. org/10.1016/j.biopsych.2015.07.028

7. Chem Biodivers. 2007 Aug; 4(8): 1770 to 1804. 8. A Systematic Review on the Pharmacokinetics of Cannabidiol in Humans Sophie A. Millar, Nicole L. Stone, Andrew S. Yates,and Saoirse E. O'Sullivan

V&M Analytical Toxicology Laboratory Services – www.vm-atls.com

Contract manufacturers for the pharmaceutical and complementary medicines markets Hersol Manufacturing Laboratories is a registered company specializing in manufacturing and packing of complementary medicines for third party companies within the local South African market. Founded in 1980, Hersol adheres to a Quality Management System which embraces current Good Manufacturing Practices in accordance with Medicines Control Council requirements.

The new 5 cubicle dispensary and sampling facilities

Hersolâ&#x20AC;&#x2122;s extensive facility features a fully equipped Laboratory to ensure quality of raw materials and finished products. It has modern manufacturing facilities for blending, granulating, compressing & coating tablets as well as encapsulating capabilities. Hersol has state of the art on-site packing facilities, including a recently introduced blister packing machine. In addition, Hersol has facilities to manufacture and pack syrups, creams, gels and ointments. Leadership at Hersol is upheld by a highly competent Management Team with vast pharmaceutical subject matter knowledge and experience in staff motivation so as to achieve a superior product.

Handling of Raw Materials when weighing and dispensing is handled in accordance with Medicines Control Council guidelines

Hersol is registered with: t South African Medicines Control Council t South African Pharmaceutical Council t South African Department of Health t Health Product Association â&#x20AC;&#x201C; HPA t Cosmetics, Toiletries and Fragrances Association t FDA Food Facility

Hersol Manufacturing Laboratories (Pty) Ltd tel: +27 11 614 6631/2

fax: +27 11 614 4615

email: admin@hersol.co.za

web: www.hersol.co.za

PHARMA FOCUS//CAMs & Health Supplements

A strong foundation for health and wellness IMCD is a reliable partner for all your nutraceutical manufacturing needs. The company has first class formulation expertise, a highly skilled technical sales team and close relationships with many of the world’s leading producers of ingredients for nutritional supplements.

he global nutraceuticals market,

dosage forms to assist customers with

according to Research & Markets,

new product development.

One of the company’s newest offerings for nutraceuticals is the Klucel

accounted for USD379.06 billion

Nutra Plus multifunctional binder. This

Affordable processing aid

is a one step, easy to use solution for

at a CAGR of 7.6 percent to reach

Ashland, an IMCD principal,

direct compression tablet binding.

USD734.60 billion by 2026.

acquired Pharmachem Laboratories

Klucel Nutra Plus provides best in class

in 2017. Pharmachem is a leading

binding, improved powder flow and

disorders such as obesity, cholesterol,

provider of quality ingredients to

excellent tablet disintegration.

high blood pressure and diabetes

the global health and wellness

along with rising global healthcare

industries. It also supplies high value

Alternative pain reliever

costs are some of the factors driving

differentiated products to fragrance

The demand for nutraceutical pain

market growth.

and flavour houses.

relief solutions is on the rise, partly

in 2017 and is expected to grow

An increase in the likelihood of health

But the market also has its challenges,

The acquisition has strengthened

which include inconsistencies in

Ashland’s specialty product line

ingredients, adulteration and raw

for nutraceuticals, which is

materials contamination, reduced

a great area of focus for

awareness of the benefits of

the company as it seeks

nutraceuticals among the

to support self-directed

geriatric population and unclear

consumers looking for

regulatory guidelines.

ways to incorporate

Nutraceuticals are dietary supplements, food additives and health and wellness products. They offer

health and wellness into all aspects of their lives. According to Ashland,

due to the desire to move away from

DID YOU KNOW?

opioids and the serious issues their misuse can cause. Experts say there is also reluctance

to include cannabidol Ashland’s Klucel Nutra Plus is an economical, one (CBD) and hemp based step excipient for direct ingredients in pain relief compression tabletting of products as they often nutritional supplements. It facilitates lower do not meet quality and processing costs during regulatory standards. manufacturing and is In addition, CBD and easy to handle. products containing CBD

various maintenance and preventative

these consumers are sitting

healthcare and fitness benefits.

less and walking more. They are

have now been reclassified by

looking for sugar reduction and

the EU as ‘novel foods’ and require

chemicals and food ingredients, has a

more fermented products, probiotics

authorisation for use. As a result,

strong and influential position within the

and fruit extracts. They are thinking

there is uncertainty around their

global nutraceuticals market.

about their health and wellness in a

status in the supplements sector.

IMCD, a leading distributor of speciality

The company focuses on distributing

broader sense; some are concerned

OptiPEA, a pain-relieving natural

high quality, innovative ingredients and

about the environment and are

nutraceutical, could meet the needs

offers formulation expertise to its

reducing their consumption of

of companies seeking a proven

to customers. Its solutions driven

animal proteins in favour of botanical

alternative to CBD. It is produced

portfolio combines speciality

extracts including aloe vera.

by Innexus Nutraceuticals and

nutraceutical actives and excipients to delivery systems.

In line with these trends, Ashland’s

offers a proven natural alternative.

technical experts have developed

This nutraceutical solution is

a variety of product options to help

also backed by over 60 years’

Germany, IMCD develops on-trend and

brand owners and manufacturers

research. It is formulated from

science based health and nutritional

meet the needs of today’s health

palmitoylethanolamide (PEA), a

supplement concepts in various novel

conscious consumers.

naturally occurring bioactive lipid,

Utilising its laboratory in Cologne,

| JULY 2019 | P C Review

PHARMA FOCUS//CAMs & Health Supplements which has consistently been shown to

Nutrition is committed to ongoing

deliver positive results without negative

herbal medicine research and employs

side effects.

tried and tested manufacturing and

PEA is a cannabimimetic, which means

business processes as well as being

it mimics the process of CBD in the body.

transparent and having full traceability

It could can even be considered a

for all its ingredients.

better alternative to hemp cannabinoid

Operating as a division of IMCD,

products because it is a single molecule,

Network Nutrition is a major advocate

making it much easier to measure into

of eliminating adulteration of herbal

precise doses.

ingredients in the nutraceuticals market.

In April, Netherlands-based Innexus

The game-changing herbal identification processes of the division are incorporated into an increasing number of ingredients

It strives for innovative ways to

Nutraceuticals became a new principal of

improve herbal identification and

IMCD, making its innovative nutraceutical

consistency. The game-changing herbal

ingredients, including OptiPEA, available

identification processes of the division

to IMCD’s customers worldwide.

are incorporated into an increasing number of ingredients. It also continues

Eradicating adulteration

to set new benchmarks in the supply

Since acquiring Network Nutrition in

of quality, reliable, plant derived

2013, IMCD has expanded its offering

healthcare ingredients. IMCD brings

in specialised plant derived, natural

formulation concepts with innovative

healthcare ingredients. Network

ingredients like OptPEA and Klucel Nutra

Nutrition’s ingredients are used by

Plus and regulatory support to assist

many of the best known international

customers and innovative product in the

healthcare brands.

market faster. •

Its range of specialty herbal extracts are produced using leading extraction technology and verified using independent quality control. Network

IMCD South Africa – www.imcdsa.co.za

P C Review | JULY 2019 |

PRESERVATIVES & ANTI-MICROBIALS

Effective, market ready Triclosan alternative With the worldwide ban on the use of Triclosan, formulators are searching for safer alternatives to prevent microbial growth in personal care products. In response to this need, Salicylates and Chemicals presents a new anti-microbial solution, Salibact.

nti-microbial protection and the related technologies are becoming more relevant today than ever before. There have

be anti-fungal. This is where

been many concerns over the nature of

the properties of undecylenic

certain actives, such as Triclosan, and

acid help in making Salibact a

their biodegradability.

potent antimicrobial, which can

Salicylates and Chemicals has envisaged

be used at a wide pH range.

a novel anti-microbial Salibact, which brings

When compared to Triclosan,

together the antibacterial properties of

Salibact is more effective at one third the

Chlorhexidine and the antifungal property of

required dosage of Triclosan (0.1 percent

Undecylenic Acid in a single molecule. The

Salibact versus 0.3 percent Triclosan – see

prevalence of both of these ingredients have

Tables 1 to 5).

increased in personal care formulations as

Salibact is available in

many previously known molecules have been

a powder form and in a 20

placed under the regulatory radar.

percent Propylene Glycol

Salibact is a promising broad spectrum

solution. Although it is not

active, which is oil soluble and, more

compatible with anionic

importantly, biodegradable. It works across

surfactants, Salibact is

multiple applications, such as oral care

compatible with amphoteric

(toothpaste and mouth washes), hair care

surfactants Coco Betaine, Lauryl

(anti-dandruff shampoos) and skin care

Betaine and Cocamidopropyl

(handwashes, bar soaps, deodorants and

Betaine; the cationic surfactant

talc powders).

Cetrimonium Chloride; and

The properties of undecylenic acid help in making Salibact a potent antimicrobial

the following non-ionic surfactants – Lauryl

A potent antimicrobial

Glucoside, Decyl Glucoside, Caprylyl/

While some other salts like chlorhexidine

Capryl Glucoside, Alkyl Polyglucoside,

gluconate are also being used in certain

Coco-Glucoside, PEG-32, PEG-75, PEG-8,

formulations – the key missing activity would

PEG-90, Poloxamer 407 and Poloxamer 184. Table 2: Inhibitory concentration of 20 percent Salibact in a Propylene Glycol solution

Table 1: Minimum inhibitory concentration of Salibact in the powder format

Test organism

MIC

Staphylococcus aureus

Test organism

<0.0001

Salibact 20% + EG

Escherichia coli

0.05

Escherichia coli

0.001

Pseudomonas aeruginosa

0.05

Pseudomonas aeruginosa

0.001

Staphylococcus aureus

0.05 0.05

Salmonella typhi

0.0005

Salmonella typhi

Aspergillus niger

0.1

Aspergillus niger

0.7

Candida albicans

0.3

Candida albicans

0.05

Table 3: Kill test

Test organism

Minimum inhibitory concentration (µg/mL) Benzalkonium Chloride

PCMX Escherichia coli

Benzethonium Chloride

Triclosan

Salibact

>200

>10

Staphylococcus aureus

>200

0.001

Pseudomonas aeruginosa

0.001

>200

Aspergillus niger

100

Candida albicans

100

0.05

The efficacy of Salibact versus other market leading anti-microbials

| JULY 2019 | P C Review

PRESERVATIVES & ANTI-MICROBIALS At the forefront of innovation

Table 4: Formulation guide

Established in 1978, Salicylates and

Sr No.

Ingredients

INCI Name

Formula 1 (%)

Formula 2 (%) Function

Water

Aqua

Surfactant

25 Surfactant

Surfactant

7 Surfactant

applications. The company has been

Polyquate 7

Polyquaternium 7

0.5

0.5 Moisturising

constantly adding new products to its

Disodium EDTA

0.1

0.1 Chelating agent

portfolio, keeping in line with market trends

Sodium Benzoate

0.5

0.5 Preservative

and formulations.

Propylene Glycol Propylene Glycol

Salisan

Triclosan

Salibact

NaCl (Salt)

Sodium Chloride

63.4

Chemicals is one of the largest manufacturers of preservatives and UV

63.6 Solvent

filters for personal care and pharmaceutical

0.3

- Anti-microbial

0.1 Anti-microbial

Salicylates and Chemicals is represented

Humectant / Solvent

throughout southern Africa by Fourchem. The manufacturing facilities of Salicylates and Chemicals have been upgraded over the years to meet market and

QS Thickener

environmental requirements.

Salibact in a handwash formulation

With its head office based in the Western Cape and regional offices in Johannesburg and Durban, Fourchem exists to supply

Table 5: Results of a kill test results on the handwash formulation

world class quality raw materials. It Test product

0.3% Salisan (Triclosan) (form 1)

0.1% Salibact (Salibact) (form 2)

Anti-microbial activity % reduction

Test organism

Exposure time

Escherichia coli

30 seconds 60 seconds

99.97 >99.99

Staphylococcus aureus

30 seconds 60 seconds

>99.99 >99.99

Escherichia coli

30 seconds 60 seconds

>99.99 >99.99

Staphylococcus aureus

30 seconds 60 seconds

>99.99 >99.99

chooses to work with the best principals in the industry and aims to supply the best possible products. •

Fourchem – www.fourchem.co.za Salicylates and Chemicals – www.preservativesindia.com

FOURCHEM 130x177 Salibact ad 6/28/19 2:09 AM Page 1 C

Composite

CY CMY

P C Review | JULY 2019 |

PRESERVATIVES & ANTI-MICROBIALS

New blends balance market demands and industry’s needs Clariant has developed an alternative solution to the preservatives found in cosmetics seen to cause skin irritation. Based on 100 percent renewable Sorbitan Caprylate, these easy to handle liquid blends also support green certifications. By Jan Gauczinski, Cezanne Vielkanowitz and Nicolas Lasbistes

he new liquid blends meet modern

better performance than that of the

Yellow meant it passed the B-criteria,

consumers’ needs, which call

individual ingredients.

which is sufficient for preservation of any

for products that have a long

cosmetics, excluding eye and baby care

Efficacy tests and findings

products. Red denoted failure, which

from microorganisms that cause skin

Each preservative option has undergone

meant the formulation has a high risk of

problems. At the same time, they will help

formulation challenge tests at two different

microbiological contamination.

formulators meet regulatory requirements

pH levels in accordance with European

and market demands with preservatives

Pharmacopoeia (Ph. Eur.) requirements.

shelf life and provide protection

that are effective and affordable. Their

In a rinse-off application, the Sorbitan

Standardised formulations of a shampoo

Caprylate, Potassium Sorbate and Capryloyl/Caproyl Methyl Glucamide

low concentration is also easy to use in

and leave-on oil were developed to

blend and the Sorbitan Caprylate and

formulation design.

represent the typical preservation

Benzyl Alcohol blend showed excellent

challenges faced by a formulator. The

efficacy at low pH.

Natural and effective

formulations were tested unpreserved, with

Sorbitan Caprylate (INCI: Velsan SC) is

the abovementioned blends and one well-

pH formulations.

100 percent derived from natural

known benchmark preservative system of

The Phenethyl Alcohol and Sorbitan

resources. One of its main raw materials,

Phenoxyethanol and Parabens.

Caprylate blend also passed at

Sorbitol, is produced from the sugar of

For both challenge tests, green, yellow

Both blends are especially suited for low

pH 5, while the benchmark blend of

corn, while Caprylic Acid is derived from

and red were used to indicate preservation

Phenoxyethanol and Parabens failed

coconut oil. It is renewable, biodegradable

suitability. Green denoted passed

against mould.

and non-toxic; Eco-Cert and Cosmos

A-criteria of Ph. Eur., which is sufficient for

approved, and China IECIC listed.

the preservation of eye and baby

Sorbate as a preservative does not make

care applications.

sense as organic acids perform well only at

In addition to its co-emulsifying and

At a high pH of 7, the use of Potassium

thickening function, it interacts with microorganism cell walls, facilitating the preservative’s penetration into cells. This enhances activity through the membrane, meaning less preservative

Table 1: Rinse-off challenge test results

Preserving System

Use conc. Pa

needs to be used. By combining Sorbitan Caprylate with Phenoxyethanol, 50 percent of

Efficacy @ pH 5

Unpreserved

Ca Ab

Use conc. Total FAIL

Efficacy @ pH 7 Pa Sa

Total FAIL

Nipaguard SCL

1.0%

PASS

losing performance. The combinations

Nipaguard SCA

2.0%

PASS

2.5%

PASS

of Sorbitan Caprylate with Benzyl

Velsan SPA

1.5%

PASS

2.0%

PASS

Alcohol and Sorbic Acid are especially

Phenoxyethanol + Paraben blend

1.3%

FAIL

1.3%

FAIL

Phenoxyethanol can be saved without

favourable, as the mixtures result in a

| JULY 2019 | P C Review

No efficacy

PRESERVATIVES & ANTI-MICROBIALS

Table 2: Leave-on challenge test results

Preserving System

Use conc.

Efficacy @ pH 5 Pa

Unpreserved

Ca Ab

Alcohol and Phenethyl Alcohol with Sorbitan Caprylate resulted in a pass unachievable with Phenoxyethanol and Parabens. For a typical leave-on cream formulation with low and high pH, all preserved blends were successful and passed the test. Regarding the results for Aspergillus brasiliensis, it must be noted the criteria in the EP challenge test targeted specific log-reduction. A B-criteria, as seen for the blend of Sorbitan Caprylate and Benzyl Alcohol and the blend Phenethyl Alcohol and Sorbitan Caprylate, means no growth of the organism. This finding would allow a pass in similar tests of the USP challenge test and ISO 11933.

Total

Efficacy @ pH 7 Pa Sa

FAIL

Total FAIL

Nipaguard SCL

1.0%

PASS

Nipaguard SCA

2.5%

PASS

2.5%

PASS

Velsan SPA

2.0%

PASS

2.0%

PASS

Phenoxyethanol + Paraben blend

1.3%

PASS

1.3%

PASS

SUSTAINABLE OPTIONS a low pH range. The combination of Benzyl

Use conc.

No efficacy

Table 3: Minimum inhibitory concentration

Preserving System

MIC (%) Pa

THERE ARE THREE sustainable blends, which

may provide solutions to market needs:

Nipaguard SCL*

0.4

0.1

0.2

0.1

1. A blend of Sorbitan Caprylate, Potassium

Nipaguard SCA**

0.6

0.15

0.4

0.1

0.08

Velsan SPA**

0.6

0.1

0.8

0.1

0.08

0.03

0.04

0.03

Sorbate and Capryloyl/Caproyl Methyl Glucamide (Nipaguard SCL) as an alternative to Benzoic Acid. This blend is high in

Nipaguard SCS**

renewable ingredients, making it ideal for the

*Tested at pH 5 **Tested at pH 7

preservation of natural cosmetics. 2. A blend of Sorbitan Caprylate and Benzyl Alcohol (Nipaguard SCA) as an alternative to Phenoxyethanol. 3. A blend featuring identical Phenethyl Alcohol and Sorbitan Caprylate (Velsan SPA) for the fragrance and preservation of a wide range of cosmetics and toiletries. It provides an alternative to phenoxyethanol.

Good alternatives Table 3 provides an overview of the preservative efficacy assessed by minimum inhibitory concentration of all four Sorbitan Caprylate based products. All products can be used to protect a formulation against all organisms and are especially valuable against yeast and mould. The four featured Sorbitan Caprylate blends in Clariant’s Nipaguard Zero

Features and applications

portfolio offer a good alternative to

The Sorbitan Caprylate, Potassium Sorbate

cosmetics and toiletries. It is slightly soluble

parabens, formaldehyde and halogen

and Capryloyl/Caproyl Methyl Glucamide

in water, readily soluble in oil phase

containing preservatives at comparable

blend preserves a wide range of cosmetics

ingredients and in many organic solvents.

costs and efficacy. The blends support

and toiletries, providing activity against

The liquid is easily incorporated into

lower levels of preservatives in formulations

gram positive and gram-negative

materials to be preserved.

and as liquids they are easy to incorporate

bacteria, yeast and mould.

into a wide range of cosmetics.

As a liquid, it is easily incorporated

Highly aqueous formulations

into formulations. It has a rather low

The recent introduction of a Sorbitan

high Ph. Eur standards and the focus

solubility in water and is readily miscible

Caprylate based blend, specifically

on sustainable ingredients creates

with many organic solvents, surfactants

for wipes and other high aqueous

confidence for formulators looking for a

and emulsifiers.

formulations, supports safer preservation

broader toolbox of preservatives. They

for this application area.

are then able to pursue different product

The Sorbitan Caprylate and Benzyl Alcohol blend is suitable for a wide range

The key is to combine Sorbitan

of cosmetics and toiletry applications. It

Caprylate with Piroctone Olamine, a well-

provides activity against gram positive

established ingredient in the market with

and gram-negative bacteria, yeasts

a long history of safe use. It is also globally

and moulds and retains activity in the

approved as a preservative.

presence of most cosmetic ingredients.

This blend (Nipaguard SCS) provides

It is slightly soluble in water and readily

additional formulating ease due to the

soluble in oil phase ingredients and in

added solubiliser system of Capryloyl/

many organic solvents.

Caproyl Methyl Glucamide and Trilaureth-4

The Phenethyl Alcohol and Sorbitan

Extensive testing according to

claims and certifications, and to balance their needs with consumer requirements. •

ABOUT THE AUTHORS

Jan Gauczinski is Clariant’s application development manager; Cezanne Vielkanowitz is the company’s senior chemist and Nicolas Lasbistes is Clariant global technical manager for personal care.

Phosphate. It provides efficacy and

Caprylate blend is designed for fragrance

flexibility with a reduction in the overall

and preservation of a wide range of

amount of preservatives.

Clariant – www.clariant.com

P C Review | JULY 2019 |

PRESERVATIVES & ANTI-MICROBIALS

Modern product protection – the real beauty hero

As regulations continue to change and the demand for safer, yet effective preservatives is growing, the delivery of innovative solutions remains at the heart of Symrise’s operations. The company is passionate about helping customers find modern product protection technologies applicable to their unique needs.

odern product protection is a new way to think of

Figure 1: Hydrolite 5 green (Pentylene Glycol) increases the bioavailability of carnosine (hydrophilic active ingredient) and significantly enhances its anti-oxidant performance: reducing ROS by 51 percent**

formulation design. It involves good manufacturing

practices, appropriate packaging, low water activity and the intelligent use of preservatives, multifunctional ingredients and chelating agents. The formulation impact of newer ingredient chemistries is about more than simply the preservation of a product. Symrise believes modern product protection must be realised at the beginning of formulation design. Historically, conventional preservatives were added at low levels at the final stage of the formulation process. Yet modern

Figure 2: Sunscreen SPF50+, results of the challenge test in accordance with European Pharmacopeia. Modern product protection system: 0.25 percent Benzyl Alcohol, 0.50 percent SymSave H (Hydroxyacetophenone), 0.25 percent Hydrolite CG (Caprylyl Glycol), 0.5 percent Hydrolite 5 green (Pentylene Glycol)

product protection ingredients need to be

E. coli

considered from inception because of their unique physicochemical characteristics.

P. aeruginosa

This is a new field of discovery for formulators – finding the best molecules

S. aureus

that offer the greatest benefits in terms of their efficacy and formulation aesthetics.

C. albicans

Symrise sees this as a door to fresh opportunities, because it’s not speaking only

A. brasiliensis

of preservation but also of the additional advantages the company’s chemistries bring to formulations.

not. Symrise educates its customers on the benefits of multifunctional ingredients.

Mistaken ingredients

The company seeks to deliver a positive

To enhance moisturisation, optimise the sensorial experience and increase the performance of active ingredients, any

Access to an enormous variety of

message in line with the healthy lifestyle

one of the following 1,2-alkanediols may be

information on the internet and social

and well-being of the consumer. Brand

added to a formulation (see Figure 1):

media easily creates a negative perception

owners and manufacturers shouldn’t focus

• Cosmos approved Hydrolite 5 green (INCI:

of any given cosmetics ingredients.

on ‘what is not in a formulation’ but rather

For a while now the focus has been on

‘what ingredients have been selected for a

• Hydrolite 6 (INCI: 1,2-hexandiol)

preservatives. Yet these ingredients are

formulation and why, based on their benefits

• Hydrolite CG (INCI: Caprylyl Glycol).

completely misunderstood.

to the user’. Multifunctional ingredients play

The aforementioned 1,2-alkanediols

a key role in this arena.

also assist in lowering the amount

Preservatives are invaluable in consumer

Pentylene Glycol)

of preservative system required in a

products. Modern product protection systems need to be both effective and safe

Spotlight on versatility

– known to Symrise as the secret heroes of

Symrise offers a wide variety of

cosmetics formulations.

multifunctional cosmetics ingredients,

portfolio, SymClariol (INCI: Decylene Glycol)

formulation (see Figure 2). Another 1,2-alkanediol in Symrise’s

which are good multi-tasking products

offers benefits beyond moisturisation by

around product protection ingredients

for formulation design. Its 1,2-alkanediols

helping to normalise oily skin. Decylene

were centred on free-from claims. These

are effective moisturisers, sensorial

Glycol has been shown to be a functional

days consumers want more transparency

profile enhancers and they help with

addition to formulations by aiming to

in terms of what’s in a product versus what’s

product protection.

reduce blemishes and breakouts. It not

Over the past 10 years, communications

| JULY 2019 | P C Review

PRESERVATIVES & ANTI-MICROBIALS

only protects a formulation (see Figure 3) by supporting product protection, but also

Figure 3: Aqueous solutions, results of the challenge test in accordance with European Pharmacopeia. Modern product protection system: 0.60 percent Phenoxyethanol, 0.20 percent SymClariol (Decylene Glycol)

helps protect skin by balancing sebum and unwanted microorganisms.

E. coli

Consumers want more transparency in terms of what’s in a product versus what’s not

S. aureus

As part of its portfolio of multifunctionals,

A. brasiliensis

P. aeruginosa

C. albicans

SymSave H (INCI: Hydroxyacetophenone) is another example of a multi-talented ingredient. It is a powerful nature identical anti-oxidant that protects a formulation from degradation and spoilage while

Figure 4: SymSave H, as a soothing agent, decreases the activity of COX-2 enzyme by 29 percent IC50 > 0.0068 percent and IC20 = 0.0023 percent

safeguarding skin from the damaging effects of free radicals. Symrise’s research has found SymSave H has even more benefits (see Figure 6). The company’s R&D work revealed SymSave H also has soothing benefits (see Figure 4), making it a great choice for a wide range of formulations, including sunscreens and face masks.

Certified green solutions Nowadays consumers expect their cosmetics to be made using sustainable raw materials produced in an ecologically and socially responsible manner. Hydrolite 5 green (Pentylene Glycol) meets these needs and, with the association of SymLite

They make it easier for manufacturers of

it can be combined synergistically with

G8 (INCI: Glyceryl Caprylate, Cosmos

natural cosmetics to improve the shelf life of

organic acids or multi-functionals like

approved), it is a completely green solution

their products (Figure 5). They also present

SymSave H (see Figure 6). SymOcide

for formulators. Both ingredients naturally

producers of conventional cosmetics with

C also has additional benefits such as

support the product protection system,

the opportunity to increase the proportion of

antioxidant capacity and antimicrobial

strengthen the skin barrier and,

sustainable ingredients in their products.

properties highly suited to oral care

as a co-emulsifier, help to keep o/w emulsions stable. Thanks to their sustainable production,

SymOcide C (INCI: o-cymen-5-ol) is non-controversial and, at a concentration

applications, making it another multitasking ingredient. •

of 0.1 percent, it allows the formulator to

SymLite G8 and Hydrolite 5 green are

keep overall preservative levels very low.

suitable for use in all kinds of cosmetics.

To achieve broad-spectrum activity,

Figure 5: Baby micellar water – results of the challenge test in accordance with European Pharmacopeia. Modern product protection system: 0.4 percent Sodium Benzoate, one percent Hydrolite 5 green (Pentylene Glycol), 0.75 percent SymLite G8 (Glyceryl Caprylate)

Symrise – www.symrise.com

Figure 6: O/W anionic emulsion aqueous solutions – results of the challenge test in accordance with European Pharmacopeia. Modern product protection system: 0.10 percent SymOcide C (O-cymen-5-ol), 0.50 percent SymSave H (Hydroxyacetophenone)

E. coli

P. aeruginosa

S. aureus

C. albicans

A. brasiliensis

P C Review | JULY 2019 |

PRESERVATIVES & ANTI-MICROBIALS

Possible new preservative entry The SCCS recently published its final opinion on the preservative, HEBP. Anina van der Walt of Lumen Regulatory Solutions discusses the ins and outs of this development, particularly in the area of eye irritancy.

DID YOU KNOW?

HEPB is also used as skin conditioning agent. According to the Cosmetics Regulation 1223/2009, a substance authorised as preservative at specific conditions of use (e.g. maximum concentration) can only be used for other purposes at the same conditions of use set up for the preservative function.

a preservative in rinse-off, oral care and leave-on cosmetics products at a maximum concentration of 0.7 perent is indeed safe in terms of eye irritation.

Amendment to the annex In the light of the data presented, and with the SCCS conclusion, the EU published the Draft Commission Regulation, amending Annex V to Regulation (EC) No 1223/2009. The draft Regulation proposes the authorisation of a new preservative ingredient, HEPB, in rinse-off, oral care and leave-on products at a maximum concentration of 0.7 percent applicable for cosmetics.

he cosmetics preservative

The authorisation process is not

At that stage, the SCCS also

4-(3-ethoxy-4-hydroxyphenyl)

concluded more evidence is needed to

butan-2-one (CAS Number

exclude the safety concern of possible

569646-79-3), also known as

eye irritation caused by this preservative.

Hydroxyethoxyphenyl Butanone (HEPB),

Eye irritation dismissed

not listed in the Regulation (EC) No

Following the concerns raised by several

1223/2009. Yet this is about to change.

EU Member States on HEPB having the potential to be a possible eye irritant, a

Consumer Safety (SCCS) concluded

follow-up assessment was conducted

in its opinion of 7 April 2017 that, under

using additional scientific data submitted

an aggregate exposure scenario, HEPB

by an applicant.

can be considered safe when used

are received on the suggested amendment, the proposed period of adoption will be during the fourth quarter 2019 (World Trade Organization

as per the INCI nomenclature, is currently

The Scientific Committee on

yet completed. If no comments

Technical Barrier to Trade notification: G/TBT/N/EU/650). For brand owners and manufacturers in the South African cosmetics industry, this possible new preservative entry is yet to be decided. â&#x20AC;˘

After this assessment, the SCCS

as a preservative in rinse-off, oral care

concluded in a subsequent opinion on

and leave-on cosmetics products at a

5 March 2019 that, under an aggregate

maximum concentration of 0.7 percent.

exposure scenario, the use of HEPB as

Lumen Regulatory Solutions â&#x20AC;&#x201C; anina@lumen.co.za

Lumen Regulatory Solutions Consultant Business Lumen is a proudly South African business specialising in Cosmetic Product Safety Assessment & Regulatory Compliance Requirements Contact details: Anina van der Walt B.Pharm M.Sc Pharmaceutics +27 (0) 84 990 9080 anina@lumen.co.za

| JULY 2019 | P C Review

SUN CARE

Is blue light ageing our skin? Although research on the effects of blue light on skin is not yet conclusive, the evidence is enough to have prompted ingredient manufacturers to produce actives to address the problem.

here is a growing body of evidence

repair process, leading to visible signs of

or artificial blue light; helps reduce wrinkles

to supports the argument that blue

ageing and dark under-eye circles.’

and fine lines; and improves skin’s texture.

Unique leaf extracts

promotes youthful cells during sun exposure.

damage, including increased pigmentation,

Inspired by botanical defence strategies,

It offers a comprehensive cellular DNA

inflammation and premature photo-ageing.

BASF Care Creations offer three extracts to

protection against UVA, UVB and blue light

protect against multiple sources of light,

and helps to promote skin’s natural DNA

especially blue light.

repair process.

light between 380 and 400nm is detrimental to skin and can cause

Data shows blue light leads to free radical damage and contributes to skin ageing in the same way as UV rays. Some research

DN-Age, a candle bush leaf extract,

Ciste’M, is an extract of Cistus

An argan leaf extract, Arganyl protects

shows blue light penetrates even deeper into

monspeliensis or Mediterranean Rockrose

DNA against blue light in two ways – DNA

the skin than UVA and UVB rays, damaging

shrub. This plant grows and thrives in arid

anti-oxidation and breakage – and has anti-

collagen and elastin.

areas where it is constantly exposed to the

pollution efficacy against particulate matter.

Estée Lauder claims blue light exposure

sun. Its leaves are equipped with a unique

Active ingredients from BASF Care

at night impacts the natural circadian

protective system from which natural

Creations are available in South Africa from

rhythm of skin cells. According to Dr Nadine

antioxidant molecules are extracted. Known

Botanichem. •

Pernodet, Estée Lauder Companies’

as myricetin glycosides, these molecules

scientific spokesperson: ‘Results indicate

form the core of Ciste’M.

exposure to blue light at night can throw

The active ingredient is 100 percent

skin’s natural circadian rhythm out of sync,

natural and vegan friendly. It accelerates

causing skin’s cells to continue to think it is

skin’s recovery and epidermal renewal;

daytime. This impacts their natural night-time

provides collagen protection against natural

BASF Care Creations – www.carecreations.basf.com Botanichem – www.botanichem.co.za

P C Review | JULY 2019 |

SUN CARE

Hybrid technology for colour and sun care products Long-lasting wear is a key benefit sought by consumers, particularly when it comes to colour cosmetics and sun care products. Although decision makers recognise the need to formulate with this benefit to stay competitive, they often have to choose between performance and affordability with either organic or silicone chemistry.

ow has launched a new hybrid film former to lead

Figure 1: Wash-off resistance expressed as a percentage, comparing products with and without Epitex film former

the way for next generation skin and sun care. Brand

owners can now offer the long lasting performance of traditional silicone acrylate technology, while achieving affordability to produce products on mass market scale, when formulating with Dowâ&#x20AC;&#x2122;s water based film former Epitex 99 Polymer. This new polymer enables formulations that protect and please, with soughtafter qualities such as high water and

Topics such as inclusion are viewed as part of the United Nations sustainability agenda and should also account for important social impacts

Due to its proven

Figure 2 illustrates a reduction in

compatibility with

colour loss of an o/w BB cream with

common cosmetics

five percent Epitex 99 Polymer,

ingredients, Epitex 99

proving excellent wear and long

Polymer can be easily

lasting resistance.

sebum repellency, flexibility, comfortable

incorporated in popular

wear and rub-off resistance. Figure

product applications

1 shows the addition of 2.5 percent

such as face and sun

Epitex 99 Polymer in an o/w sunscreen

care products, colour

improves the wash-off resistance

cosmetics, BB creams and

silicone chemistry. This has enabled the

while maintaining a light sensory feel.

water based eyeliners.

company to make its high performance

| JULY 2019 | P C Review

Fabienne Bi zeray

An inclusive technology Dowâ&#x20AC;&#x2122;s new polymer builds on its combined heritage of organic and

SUN CARE Figure 2: Colour loss of various o/w BB creams expressed as a function of rub-off cycles on a felt band

DID YOU KNOW?

care products more affordable, which

Epitex 99 Polymer empowers formulators

Dow maintains ‘is another kind of

with several advantages, including:

positive difference it seeks to enable’.

• greater formulation and

Fabienne Bizeray, global strategic marketing leader for Dow Home and Personal Care, comments: ‘A holistic assessment of sustainability must go beyond ingredients alone. Topics such

manufacturing process flexibility • good performance in pure film as well as w/o and o/w formulations

Long lasting wear is a key benefit for consumers. About 37 percent of new colour cosmetics products claim long duration. Silicone based film formers provide this benefit, mostly in high end colour cosmetics.

performance while improving the availability of quality care for as many consumers as possible. •

• optimal balance between cost in use and performance.

as inclusion are viewed as part of the

Available in South Africa from

United Nations sustainability agenda

ChemSystems, this new generation

and should also account for important

of hybrid technology is particularly

social impacts.’

suited to meet the demand for superior

ChemSystems – victor.berowsky@aeciworld.com @DowHomePersonal

P C Review | JULY 2019 |

SUN CARE

Croda supports proposed regs for safer sunscreens

The manufacturer of personal care ingredients has welcomed the FDA’s announcement on a proposed update to regulatory requirements for sunscreens in the US.

he proposed update

This proposed update on

formulators and brands in all markets

would reclassify Titanium

safe and effective ingredients in

of the world to meet the sun care

Dioxide (TiO 2) and Zinc

sunscreens helps formulators and

needs of modern consumers.’

Oxide (Z n O) as Generally

consumers cut through ambiguity

Recognised as Safe and Effective,

in the marketplace. It also clearly

or GRASE category I.

identifies metal oxide technology

Metal oxide dispersions and powders

as a preferred route to safe and

Croda offers a range of metal oxide

Previously none of the 16 mineral-based sunscreen active ingredients currently on the market were considered GRASE. This new update would help to eliminate confusion among sunscreen formulators and consumers alike, with the new assessment of these sunscreen ingredients. The proposed

effective UV protection.

DID YOU KNOW?

Solaveil brand. The Solaveil Clarus range

Mineral based sunscreens

The natural composition of Helene Hine, Solaveil XT-40W is ideal for formulators looking to develop marketing manager green sun care products. It offers of Croda Personal the freedom to formulate light and spreadable o/w emulsions for Care, Solar natural, globally approved, high Protection, comments: SPF sun protection products, which conform to EU ‘We have seen the guidelines for sun care market moving UVA protection. towards TiO 2 and Z n O for

reclassification changing TiO 2 and Z n O to GRASE category I, would see

dispersions and powders under the

some time now. The trend is largely driven

of TiO2 and Z n O actives possess a tightly controlled particle size distribution ensuring the active ingredients provide true transparency on the skin while maintaining excellent UV protection. The award-winning Solaveil SpeXtra range of TiO 2 products uniquely allows for formulating high SPF, broad spectrum sun protection products using a single active ingredient. The Solaveil dispersions are available in different carrier fluids for

them categorised as satisfactory

by consumers’ desire to move

formulation versatility; the powders

according to three criteria,

away from chemical sunscreens,

offer formulators alternatives when

which designate them safe and

which are petrochemical derived

dry actives are needed, making these

effective for their intended use.

ingredients,in favour of mineral

Solaveil metal oxide technologies very

This designation is through testing

based sunscreens.

easy to use in wide range of personal

and the publication of said testing

Croda welcomes this news,

in scientific literature available to

which further confirms the safety

experts. What this would mean,

of these invaluable ingredients,

is no other data is required for

no matter the particle size. In

TiO 2 and Z n O to be used in

addition, being globally approved,

sunscreen formulations.

this opens up new possibilities for

ALPAFLOR ® SCUTELLARIA AO

Relieve urban stress for incomparable skin comfort Cosmetic Applications: • Anti-pollution products • For dry and irritated skin • Focus on soothing sensitive skin

pc.communications@dsm.com

| JULY 2019 | P C Review

care applications. •

Croda – www.crodapersonalcare.com

Value Chain Fully Sustainable

• Spa and wellness care • Promotes a healthier skin barrier

facebook.com/dsmpersonalcarebeauty

T: +27 (0)12 349 1543 E: charmaine@chempure.co.za www.chempure.co.za

Tropical positive vibes

Crodarom® Banana Flower EC

Win-win collaboration

• Emblematic icon of the « tropical » trend

Mayotte origin

• A natural booster of happiness • For a pampered and balanced moisturised complexion

Flower of good mood

• Sustainably sourced in Mayotte along with our « Be ACTIVEly Committed » strategy

Anti-stress ingredient

More information on www.crodapersonalcare.com

Innovation you can build onTM

Member of Croda International Plc

SUN CARE

Keep it cool to prevent injured skin Research shows it is not just sun’s rays that damage skin, causing ageing and pigmentation. Any increase in skin’s temperature for prolonged periods can cause damage. This is known as thermal ageing.

hanges to the skin as a

occurrence leading to inflammation may

angulata plant, also known as the wild

result of heat exposure are

stimulate melanocytes, which cause

or ground gooseberry found in tropical

essentially a type of injury.

hyperpigmentation or age spots.

regions where sunlight is more intense.

and can lead to a breakdown of the

Intense repairing technology

biodegradable. It has anti-pruritic

extracellular matrix. This results in fine lines

Chemyunion, represented locally by

and soothing properties essential for

and wrinkles as well as pigmentation.

Chemgrit Cosmetics, has recognised the

sensitive or sensitised skin. It regulates

pivotal role heat induced inflammation, or

skin temperature and microcirculation,

to damage the skin. Yet studies suggest

any other aggressor, plays in the ageing

maintaining its baseline levels, even

heat and UV rays may contribute to

process. The company launched Physavie,

after external aggression.

premature ageing. Scientific knowledge

which has a unique mechanism of anti

about the effects of heat or infrared light,

thermal-ageing action to shield skin from

is proven and associated with

which increases the temperature of the

damage caused by rays of IR and visible light.

photoprotectors, which reduce

skin, is limited. What is known is human

It has excellent soothing properties, due

skin temperature can be increased up

to its capacity to reduce key inflammatory

and visible light without interfering

to about 40°C during summer midday

mediators. As a corticoid-like repair

with the formation of erythema,

sunlight within 15 to 20 minutes. This heat

solution, Physavie offers similar effects as

required for Solar Protection Factor or

may significantly contribute to inducing

hydrocortisone without the side effects.

SPF determination. •

This causes inflammation

Previously only sunlight was perceived

skin damage. When it comes to sunscreens,

Physavie is 100 percent

Its anti thermal-ageing action

the damage caused by rays of IR

Physavie is suitable for use in sun care, after sun, face and eye care, makeup,

chemical sunscreens work by

male grooming and sensitive skin

transforming UVB radiation to heat

care applications.

energy. This generation of heat by the sunscreen may contribute to the

Biodegradable and effective

increased feeling of skin warmth, which

This innovative ingredient is a vegetal

may lead to skin damage. In fact, any

active extracted from the Physalis

Chemgrit Cosmetics – www.chemgritcosmetics.co.za Chemyunion – www.chemyunion.com/en

Instrumental analysis showing how Physavie helps maintain skin temperature

Chemgrit Cosmetics realise that people are the key to our success, our customers, suppliers and personnel are our future. We believe in operating our business with integrity, efﬁciency and service excellence. CHEMGRIT COSMETICS (PTY) LTD 7 HAROLD FLIGHT ROAD, JET PARK, BOKSBURG, 1459. 011 397 4455 / 082 853 7589

| JULY 2019 | P C Review

SUN CARE

Cotton to cushion skin from sun damage The sun is one of the main environmental factors contributing to skin damage. Vytrus Biotech’s Arabian CottonPRCF accelerates the repair of photo-damage caused by solar radiation.

rabian CottonPRCF (INCI: Glycerine (and) Gossypium Herbaceum (Cotton) Callus Culture (and) Gluconolactone (and) Sodium

Benzoate) is a glycerine based active ingredient. It is derived from the cultured and lysed plant stem cells from Gossypium herbaceum, obtained using Vytrus Biotech’s Plant Cell Biofactories technology. Vytrus Biotech has proven that plants’ totipotent cells, also known as plant stem cells, can repair, protect and regenerate

THE BENEFITS OF ARABIAN COTTONPRCF • broad spectrum protection • bio-protection against photo-induced ageing • natural photo-protection against solar radiation (UV, VIS and IR) • multi-active ingredient • soothing • anti-inflammatory • antioxidant • regenerative.

damage, Arabian CottonPRCF is enriched and standardised in a characteristic phyto-complex of polyphenolics from the extremophile plant. The active ingredient was originally designed to provide broad spectrum photoprotection against UV and IR radiation. In 2017, Vytrus performed two new in vitro efficacy tests to measure the protoprotective action of Arabian CottonPRCF against blue light. The results of the first test showed a 24 percent reduction in the

damaged tissue. This exceptional potential

protect and repair its structures against

intracellular ROS production compared

of totipotent cells forms the base of Vytrus’

sun damage.

to untreated cells irradiated with a lamp

products, available in South Africa from Savannah Fine Chemicals.

Blue light protection

showed a 15 percent increase in cell viability

Extended sun exposure causes sunburn,

compared to basal level and a 36 percent

semi-arid regions of sub-Saharan Africa

erythema or inflammation and several

increase in cell viability compared to

and Arabia. Because it grows in harsh

chronic skin issues, including photo-ageing

untreated cells irradiated with HEV light. •

environmental conditions, it has developed

and an increased risk of skin cancer. To

extensive and diverse defence molecules,

complement and boost the defence

such as phenols and flavonoids. These

mechanisms of skin’s cells to overcome

molecules help the plant’s cells to

the sun induced ageing and photo-

OCEAN-FRIENDLY AND DURABLE SUN PROTECTION. WHY NOT? Growing awareness of the effects of sunscreen on the world’s oceans is motivating important revisions in sun care products. Innovative formulations now provide durable UV protection while helping to reduce damage to aquatic ecosystems. The choice of biodegradable and high-performing ingredients is crucial. Covestro is proud to offer Baycusan®: an eco-friendly line of water-resistant polyurethane film formers that can have the ability to biodegrade.

Savannah Fine Chemicals – www.savannah.co.za Vytrus Biotech – www.vytrus.com

Covestro Deutschland AG, 51365 Leverkusen · COV00086539

The Arabian Cotton plant is native to the

emitting HEV light. In the second test, results

For more information, contact us at cosmetics@covestro.com! Beauty Made Responsible. Y) LTD CHEMICALS (PT SAVANNAH FINE a | www.savannah.co.za o.z info@savannah.c

Distributed by

baycusan.com AZ_Baycusan_Kids_130x177mm_Savannah_0719.indd 1

01.07.19 14:20

P C Review | JULY 2019 |

SUN CARE

Organic versus inorganic sunscreens While the photodegradation of organic UV filters is commonly recognised and understood, the photoactive risks associated with inorganic UV filters are not well publicised. Eileen Zhang of Hallstar Beauty explains the differences between the two sunscreen filters and how to protect them.

insufficient to inhibit all their photoactivity. As a result, common inorganic sunscreens used today convey a false sense of security to the consumer.

DPPH monitoring test To reveal and monitor the photoactivity of inorganic filters, Hallstar proposed a test utilising the well-studied chemistry of DPPH (1,1-diphenyl-2-picrylhydrazyl), used as a free

rganic UV filters are a group of

There is a common misconception that

radical indicator. DPPH is a stable radical

carbon-containing compounds

inorganic filters are safer than organic

that scavenges other more reactive radicals.

designed to absorb UV

ones because they only reflect, scatter

When used in a solution, it has a deep violet

radiation. To maintain

and refract sunlight. Yet TiO2 and ZnO are

colour. When it reacts with and is neutralised

effectiveness over time, they should not alter

both semiconducting materials capable

by other radicals, the solution becomes pale

chemically after repeated UV irradiation.

of absorbing UV energy, which contributes

yellow to colourless.

Yet when many common organic UV filters

most of their UV shielding ability. After

absorb UV radiation and enter an excited

absorbing UV energy, these mineral

of 0.01 percent (w/w) DPPH were used to

state, they are often unable to release

particles become photoactive.

disperse TiO2 particles. The solution was

energy quickly to return to their ground state.

TiO2 and ZnO are well-known active

During a typical test, ethanolic solutions

irradiated under simulated or natural

This is when they are stable and ready to

photocatalysts used extensively in

sunlight. Solutions with a common

absorb additional UV energy.

heterogeneous photocatalysis to destroy

commercially surface treated TiO2 turned

Common inorganic sunscreens used today convey a false sense of security to the consumer

to pale yellow, indicating the generation of abundant free radicals. Yet when AvoBrite was added to the solution, it prevented the photogeneration of free radicals in a dosedependent fashion. This was indicated by

environmental pollutants that are organic

the different shades of DPPH in the presence

time in the sun, losing their absorption

in nature.1 When photoactivated by UV

of different amounts of AvoBrite.

capability and generating photoproducts,

light, they are known to generate highly

This test can easily be implemented in a

which haven’t been investigated

oxidising radicals such as hydroxyl (OH)

lab, giving sunscreen producers a quick way

for their safety on human skin. One

and other reactive oxygen species like

to evaluate the photoactivity and photo-

example is Avobenzone (INCI: Butyl

H2O2 and singlet oxygen, 1O2. H2O2 and

safety of inorganic sunscreens. To provide

Methoxydibenzoylmethane). Although it’s

1O2 are known to be cytotoxic and/or

the market guaranteed safety for inorganic

common and globally approved UVA filter,

genotoxic. OH radicals photogenerated

filter solution, Hallstar manufactures pre-

Avobenzone is notoriously unstable under

from photoactive TiO2 specimens extracted

protected inorganic dispersion products –

UV radiation. Hallstar, represented locally

from commercial sunscreen lotions induce

the HallBrite EZ-FLO TDX (TiO2 dispersion) and

by Millchem, was one of the first companies

damage to DNA plasmids in vitro and to

HallBrite EZ-FLO ZDX (ZnO dispersion) series. •

to discover its photodegradation and

whole human skin cells in cultures.2 To

dedicated many years of research to

restrict the photoactivity of inorganic UV

developing a range of solutions to stabilise

filters, all TiO2 and ZnO used in sunscreens

REFERENCES

the filter. The result was cutting-edge

needs to be surface treated. Unfortunately,

1. Nick Serpone, Daniele Dondi, Angelo Albini. Inorganica

photostabilisation products SolaStay S1

the quality of such treatment is not well

and Polycrylene, as well as the new China

controlled or monitored and is often

Unstable UV filters photodegrade over

Chimica Acta 360 (2007) 794-802 2. R.Dunford, A. Salinaro, L. Cai, N. Serpone, S. Horikoshi,

H. Hidaka, J. Knowland, FEBS Lett. 418 (1997) 87

compliant photostabiliser, AvoBrite.

Inorganic UV filters These are a group of mineral oxides such as titanium dioxide (TiO2) and zinc oxide (ZnO). They are often referred to as physical filters, making them inorganic.

The results of Hallstar’s DPPH test on TiO 2 , with and without the photostabiliser, AvoBrite

| JULY 2019 | P C Review

ABOUT THE AUTHOR

Eileen Zhang is the global product manager for sun care solutions at Hallstar Beauty. She also leads Hallstar’s business development efforts in Korea, Japan, Australia/ Oceania and southeast Asia.

Hallstar – www.hallstar.com Millchem – www.millchem.co.za

PROCESS & MANUFACTURING TECHNOLOGY

Small pharma sensor offers a safety game changer New fail-safe technology is enabling pharma companies to monitor and log ambient, cold and freezing conditions of products, from the point of manufacture to the patient’s refrigerator. This is done by simply by attaching and breaking the start tab of the Libero ITS indicator.

istributed by local technology integrator, The Libero ITS temperature indicator offers a solution that provides end to end quality assurance needed in the last mile

Euca Technologies, the Libero ITS indicator is

a small device that monitors the temperature stability and shelf-life of a product during the end to end journey. Indicator Tab Start (ITS) technology means it’s simply started by breaking a tab. Compared to traditional, bulky data loggers, the Libero ITS is thin and durable to attach at unitlevel or on a clinical kit for

DID YOU KNOW?

patient administration. One pharma shipment

off at multiple depots

The Libero ITS indicator is smaller, thinner, more durable, more intelligent and less expensive than any other indicator available on the market. Source:

and transferred to the

www.shop.elpro.com

may pass through various countries with different temperature conditions, get handed

next supply chain partner, wholesaler or pharmacy. Euca Technologies’ managing director, Ernest Campling, says: ‘This is where the Libero ITS adds value, as it is smart enough to record deviations, create reports and manage individual stability budgets.’

Cloud storage ‘The free Smartphone app is a great convenience tool for any receiving

calibration certificate.’

Small, smart and affordable

the monitored product. He adds, ‘The PDF can be archived in a cloud database, LiberoManager. Valuable data is also catalogued to support logistics

expedite sending site packaging processes • end to end unbroken temperature monitoring by using one device on box-level to monitor the entire chain • constantly calculates and shows the remaining stability budget for an immediate ‘go’ or ‘no go’ product release decision at any time

call it a ‘game changer’ for its ability to

• four year battery life

offer one validated device to measure

• 30 by 30mm in size, this very small device is easy

temperature for up to four years in a long,

to attach to any unit-level package using self-

fragmented supply chain.

adhesive tape

The affordability, size and smart capabilities of this long-

• status and statistics can be downloaded and documented wirelessly via the Libero ITS

term indicator at unit-level

smartphone app

offer exciting possibilities to

• data is archived and used for trending and dashboards.

improve patient outcomes,

need to piece together different “time

communicate the release or status of

• pre-configured with specific product stability budget to

The first customers to review the new ITS

used. This functionality alleviates the

to print or email a PDF report to

having gone through rigorous

device also comes with a NIST traceable

showing the percentage of budget

The app also allows the user

company, the sensors are

KEY ADVANTAGES OF LIBERO ITS:

fully GDP and GSP compliant,

ensuring FDA CFR 21 Part 11. Each

one-touch stability budget read-out,

Campling explains.

Elpro, a global monitoring

US and international validation,

site, clinic, or pharmacist. It provides a

out of refrigeration (TOR)” segments,’

trending. Manufactured by

reduce product waste and Er nest ing Cam pl

support on-time safe clinical

also one of the most cost-effective, long

trials. Using a smartphone

term solutions on the market. At the recent

app, the stability budget can be read at point of use. ‘The Libero ITS offers end to end assurance for increasingly complex

IQPC Cold Chain Global Forum, Libero ITS was awarded the 2018 Excellence Award in the category Best Global Temperature Control,’ concludes Campling. •

global supply chains, with several transit and storage points and various handlers. It provides unbroken monitoring from point of manufacture to time of use. It is

Euca Technologies – www.euca.co.za

P C Review | JULY 2019 |

PROCESS & MANUFACTURING TECHNOLOGY

Counting on cosmetics for record growth Since establishing a dedicated division for the cosmetics industry in 2018, Marchesini has made significant progress in growing this area of its business. The group has just announced the newest developments in its beauty division and started construction on a cosmetics galaxy hub. Construction is underway on Marchesini’s cosmetics galaxy, which will act as the hub for its beauty division

customers’ needs. In South Africa, MGSA Projects is the appointed agent and local Marchesini technical service provider. Owned and managed by Myles Davis, MGSA Projects employs a Marchesini trained technician and holds stock of machine spares.

The way forward Both companies will be taken over with majority shares, yet their production processes or reference partners will

he Marchesini Group has

manufacturing know-how and

finalised two new acquisitions

advanced technology,

of companies supplying

further enriching the

the cosmetics industry, to

group’s end of line

boost its strategy for rapid expansion.

product offering.

Axomatic, based in Settimo Milanese,

Reliable and efficient

Milan, is the first of the companies

end of line solutions are

acquired. It excels as a leader in the

key in the production

Made in Italy branded packaging

of cosmetics and

machinery sector, specialising in automatic equipment for the cosmetics,

DID YOU KNOW?

pharmaceuticals. Marchesini’s true strength lies in

remain unchanged. Axomatic and V2engineering will continue to manage their customers, projects and products self-sufficiently, according to consolidated internal dynamics. Marchesini will be a majority shareholder and will monitor and supervise the organisational and commercial activities of

both companies. In 2018, cosmetics brands the fact that all They will also retain their and manufacturers based in Pietro Cassani, Italy exported products worth food industries. its machines CEO of the existing, well-established €567 million to France, marking a Marchesini Group Axomatic brings and systems corporate structures and 2.9 percent increase in 2017’s sales figures. Italian made cosmetics 30 years’ expertise are produced will continue to meet the exported to Germany and the and a major portfolio in house, in Italy. This requirements of their global cosmetics United States also increased last year, by 6.9 and 21.3 of multinational guarantees their Made industry customers, rapidly, efficiently percent respectively. customers to Marchesini. in Italy quality while and with flexibility. Source: Cosmetica Italia Together with Dumek, contributing to the country’s ‘We are really proud to join such which has been part of the economy through working with a giant enterprise as Marchesini,’ pharmaceutical and

Marchesini Group since 2017, it will

a solid and extensive network of sub-

make a significant contribution to

suppliers. These are mainly technical

consolidating the group’s beauty

facilities and small businesses

division, which is essential for

specialising in quality machining

Marchesini’s growth.

services which produce most of

The second business acquired is V2engineering, a specialist producer of cartoning machines, based in Zola

the components used to make the group’s machinery. The group also operates foreign

Predosa, Bologna. V2engineering’s

sales offices and has a global network

machines combine renowned Italian

of agents for optimal response to

| JULY 2019 | P C Review

comments Luca Olivieri, CEO of Axomatic. ‘We have been working in this field for 30 years and we are a proud supplier to some of the biggest multinational enterprises in the cosmetics industry. Becoming a part of Marchesini will boost our business incredibly.’ Carlo Veronesi, CEO of V2engineering expressed similar thoughts on the acquisition. ‘Like Marchesini, we also

PROCESS & MANUFACTURING TECHNOLOGY

began operating in the Packaging

are building a 9 000m² factory

Valley of Emilia-Romagna, in Italy.

dedicated entirely to the

This was the first productive chain in

cosmetics industry.’

Europe of packaging machines for

For fast and efficient labelling, Marchesini offers an automatic rotary labelling machine designed especially for cosmetics

The project kicked off in

pharmaceuticals and cosmetics. The

May 2018 and work on the

new partnership will definitely be a great

group’s new beauty division

opportunity for both businesses and it

recently got underway when

will strengthen our position against the

the foundations were laid for

German competition.’

the construction of offices and

TO BE CONSTANTLY TO BE CONSTANTLY AT THE FOREFRONT OF TECHN AT THE FOREFRONT OF TECHNOLOGY EFFICIENCY MAKES THE DIFF EFFICIENCY MAKES THE DIFFERENCE production facilities. Once up and

Cosmetics galaxy hub

running, the beauty division will act

‘We continue to grow, and we can’t

as a hub for Marchesini’s cosmetics

stop here,’ remarks Marchesini Group

galaxy, which, thanks to these latest

CEO, Pietro Cassani. ‘With these two new

acquisitions, is expected to achieve a

acquisitions we are moving in a clear

€50 million turnover during 2019.

direction – strengthening our business

The latest snapshot of statistics from

even further in cosmetics packaging,

the international industry association,

respecting customers’ requirements and

Cosmetica Italia depicts an expanding

We continue to grow, and we can’t stop here

Lombardy districts. These SMEs produce global market leading cosmetics

cosmetics industry, in Italy and

TO BE CONSTANTLY AT THE FOREFRONT OF TECHNOLOGY EFFICIENCY MAKES THE DIFFERENCE products in line with quality principles of

worldwide. In 2018, the total earnings of

the Made in Italy brand. •

Italy’s cosmetics industry reached €11.2 billion, with exports valued at more than 42 percent. France is reportedly the

Marchesini Group – www.marchesini.com MGSA Projects – +27 (0)82 460 2766

biggest export market for Italian made

requests, which are often very different

cosmetics. Most of the SMEs that supply

to those of the pharmaceutical industry.

the bustling French cosmetics market

To continue to meet these needs, we

are based in Italy’s Emilia-Romagna and

TO BE CONSTANTLY AT THE FOREFRONT OF TECHNOLOGY EFFICIENCY MAKES THE DIFFERENCE • CONTINUOS INVESTMENT IN R&D • 500 PATENTS GRANTED • FAST FORMAT PRODUCTION COMPLEX MARCHESINI GROUP. WE MAKE THE DIFFERENCE. MGSA PROJECTS (PTY) LTD Mobile +27 (0) 82 460 2766 Myles@mgsaprojects.co.za

MARCHESINI.COM

• CONTINUOS INVESTMENT IN R&D CONTINUOS INVESTMENT IN R&D •••500 PATENTS GRANTED 500 PATENTS GRANTED ••FAST FORMAT PRODUCTION FAST FORMAT PRODUCTION COMPLEX COMPLEX MARCHESINI GROUP. WE MAKE THE DIFFERENCE.

MARCHESINI GROUP. WE MAKE THE DIFFERENCE. MGSA PROJECTS (PTY) LTD Mobile +27 (0) 82 460 2766 Myles@mgsaprojects.co.za

MGSA PROJECTS MGSA PROJECTS(PTY) (PTY)LTD LTD Mobile +27 (0) 82 460 2766 Myles@mgsaprojects.co.za Myles@mgsaprojects.co.za +27 (0) 82 460 2766

• CONTINUOS INVESTMENT IN R&D • 500 PATENTS GRANTED

P C Review | JULY 2019 |

PROCESS & MANUFACTURING TECHNOLOGY

Flexibility, quality and output with a modular approach Groninger, based in Schnelldorf, Germany, has delivered its first FlexClean. This new air-rinsing machine is founded on the company’s ready-engineered philosophy.

Matcon’s liquid addition system

Liquid addition presents a development in IBC blending

ith continuous change in consumer demands, manufacturers must have flexible and efficient production processes to stay ahead of their

competition. Until now, if a powder blend required a liquid addition, it was necessary to use a fixed mixer, which can be difficult and time consuming to clean between changeovers. Developed and produced by Matcon, the innovative liquid addition system expands the intermediate bulk container (IBC) tumble blender range. It is well suited to

Groninger’s new FlexClean

industries that require the flexibility to add liquids into a wide range of powder recipe mixes in a contained and

he modular approach of

‘We gave our unit an oval shape.

the FlexClean picks up on

Compared to a rotary design, the time

the business line concept

during which the bottles are upended

Groninger introduced into its

in the conveyor and rinsed is much

product portfolio for the cosmetics

longer, so it is far less likely particles

and consumer healthcare markets,

will be left in the bottles,’

a few years ago.

he explains.

We have managed to satisfy customers’ requirements for more flexibility and higher output performance

Different transport carriers can be mounted on the base holders. For smaller formats with high outputs, holders carrying three objects can be mounted. Two objects per holder can be processed simultaneously for larger formats. This results in a maximum output of up to 180 bottles per minute. ‘Once again we have managed to satisfy customers’ requirements for more flexibility and higher output performance,’ concludes Steck.

‘We used to purchase air-

Groninger’s portfolio of filling and

rinsing machines from third party

closing machines for the cosmetics

suppliers,’ recalls Groninger’s

and consumer healthcare markets

design team manager, Michael

is available in South Africa from

Steck. He and his team played a

Reitech SA. •

key role in developing the stand-

Steck says maximum flexibility, output and quality are the key advantages of the new air-rinsing machine.

| JULY 2019 | P C Review

The system works by automatically injecting one controlled liquid shot per rotation directly into the powder mix enclosed in the Matcon IBC during its blending cycle. This process occurs without the need for manual intervention or to open the blending vessel. It also ensures even dispersion of liquids in the powder recipe, preventing lumps from forming during the mixing process.

A valuable system This flexible and hygienic liquid addition system reduces manual handling requirements within the process and improves containment, enhancing the benefits of IBC blending. It is designed for manufacturers that need to deliver additions of liquids between the range of five to 150ℓ. It consists of a free-standing pillar supporting a reciprocating pump and weight monitoring system onto which a liquid tank is mounted. These connect to the IBC via the Matcon Liquid Additions Intensifier using triclamped hoses and a rotary coupling. To minimise the downtime for cleaning, operators can swap out parts without the need for additional tooling, keeping the blender in production and improving the efficiency and throughput of a production facility.

alone machine.

Advantages in focus

efficient manner.

The system also includes CIP flushing for neutral oils or cleaning fluids. •

Groninger – www.groninger.de/en Reitech SA – www.reitech.co.za

Matcon – www.matconibc.com

ASSOCIATION NEWS//

Swings, gin and jelly beans at Coschem’s annual golf day

he core focus of the Society of

The Coschem annual golf day is one

Cosmetic Chemists (Coschem)

the industry’s most well attended social

is the dissemination of scientific

events. It took place on 21 May at the

information among its members

Bryanston Country Club in Johannesburg.

and likeminded industry professionals. Within this focus, is an active strategy to bring together people from the personal care and cosmetics industry at social functions and networking events.

Funds raised from the sale of mulligans were donated to the Rhino Orphanage. •

Check out some of the highlights in the P C Review Coschem golf day gallery.

The winning four ball was the Savannah Fine Chemicals team, consisting of customers and guests playing on behalf of the company

P C Review | JULY 2019 |

Tea time TO ADVERTISE IN Anita Raath Sales executive

+27 (0)82 976 6541

Sudoku

Carla Melless Sales executive

+27 (0)83 260 6060

Càndida Giambò-Kruger Sales executive

+27 (0)71 438 1918

Daleen Filbey Sales executive

ADVERTISERS' INDEX

+27 (0)83 409 3119

Bruker SA.............................................. OBC.........www.bruker.com/optics Canbigold..................................................5.........www.canbigold.com Chemgrit Cosmetics................................34.........www.chemgritcosmetics.co.za Chempure ..............................................32.........www.chempure.co.za ChemSystems .........................................31.........www.dow.com Croda SA ................................................33.........www.crodapersonalcare.com CTFA..........................................................7.........www.ctfa.co.za Fourchem................................................23.........www.fouchem.co.za Hersol Manufacturing Lab ....................... 19.........www.hersol.co.za IMCD SA..................................................21.........www.imcdgroup.com Kirsch Pharma SA................................. OFC.........www.kirschpharma.com Lumen.....................................................28.........anina@lumen.co.za MGSA Projects.................................. IFC, 39.........myles@mgsaprojects.co.za Savannah Fine Chemicals........................35.........www.savannah.co.za SOFW Journal.......................................... 11.........www.sofw.com Vantage Speciality Chemicals .................29.........www.vantagegrp.com

| JULY 2019 | P C Review

Answers

Online

INDUSTRY WEB REVIEW ESSENTIAL SPECIALISED PRODUCTS

COSCHEM

Supplier of cosmetic and personal care ingredients.

Visitors to the Society of

Ingredients include; Bioferments, Botanical Extracts, Delivery

Cosmetic Chemists’ website will

Systems, Enzymes, Functional Actives, Silicones, Emollients,

find information on membership,

Emulsifiers, Meadowfoam Seed Oil & Derivatives, Abyssinian and

educational programmes

other Oils, Shea and other Butters, Aliphatic Hydrocarbons, Lanolin

(specific details pertaining to the

& Derivatives

Cosmetic Science Training), as well as the society’s objectives of promoting professionalism and higher technical skills in the

Tel: 010 595 9690

cosmetics and toiletries industries.

Email: info@esp-sa.co.za www.esp-sa.co.za

www.coschem.co.za

M&L LABORATORY

DALGEN

M&L Laboratory Services (Pty) Ltd, provides clients with an

Dalgen is a leading supplier of high-quality glass containers,

extensive array of analytical capabilities. M&L renders testing

plastic containers, closures and packaging accessories.

services to the Food & Beverage, Mining, Environmental, Water & Pharmaceutical sectors. M&L is an ISO 17025 accredited facility, licenced by the Medicine Control Council (MCC) & endorsed by the World Health Organisation (WHO). Our schedule of accreditation can be viewed via www.sanas.co.za

Tel +27 (0)31 569 4288 Fax +27 (0)31 569 4294 Email sales@dalgen.co.za or purchasing@dalgen.co.za www.dalgen.co.za

Mobile: +27 (0)76 114 9420 Office: +27 (0)11 661 7900 Email: keshav.beachen@za.bureauveritas.com

FORMPAK

BRB SILICONES

For over 40 years Formpak has supplied specialised processing,

The largest independent producer in the world of

packaging and printing machinery to the pharmaceutical, cosmetic, plastic, glass, chemical, food and dairy industries.

Tel +27 (0)11 828 8870/1/2 Fax +27 (0)11 828 8880 Email haase@formpak.com or service@formpak.com www.formpak.com

H&R AFRICA Your world's leading supplier of top quality mineral oils, petroleum jellies, and paraffin waxes, as well as customer-specific formulations. If you want to come out top you have to partner with the world's top leaders. Connect with us to see how we can connect your business to the world.

core and specialty silicones, BRB offers a wide range of solutions with unique benefits in skin, body and hair care and colour cosmetics.

www.brb-international.com

QUANTUM COLOURS SA Your No. 1 industry leader for the most comprehensive ranges of both synthetic and natural colours – used in food, pharmaceutical, cosmetic and industrial applications. Tablet coatings – manufactured,

113 Trinidad Road, Island View Bluff, Durban 4052, South Africa Tel: +2731 466 8700 Fax: +2731 466 8716/7 Email: sasales@hur.com Website: www.hur.com

supplied and marketed globally under our trade name PHARMASPEC™ - FC

www.quantumcolours.com

Spectroscopic Solutions for the Validated Pharmaceutical Industry ALPHA

FT-IR Spectrometer www.bruker.com/alpha

TANGO

FT-NIR Spectrometer www.bruker.com/tango

OPUS Software supports traceable Reference Standards Instrument Qualification according to USP, PhEur, JP Internal Validation Unit (IVU) for automated OQ & PQ Full 21 CRF part 11 support for Data Security, Integrity, Traceability

TodayÂ´s regulated pharmaceutical laboratories must comply with extensive regulatory requirements. Bruker offers together with its highend FT-IR, FT-NIR and Raman spectrometer line comprehensive system validation tools to achieve systematic and cost-effective compliance.

BRAVO

Handheld Raman Spectrometer www.bruker.com/tango

Bruker South Africa PTY LTD

Innovation with Integrity

Tel: +27 11 463-6040 Fax: +27 11 463-6289 E-Mail: info.za@bruker.com

FTIR/FT-NIR/Raman

Pharmaceutical & Cosmetic Review July 2019

Articles inside

Swings, gin and jelly beans

Organic versus inorganic sunscreens

Possible new preservative entry

The highs of cannabis testing

Is your future dosage patent vulnerable to ‘obviousness’?

HPCI expo heads to SA this September