Issue 3– March&April 2015
2015 Fecc Annual Congress Athens, Greece
Your chance to network and expand your business globally !
Inside this issue Members’ news Fecc Activities EU Chemicals Legislation Responsible Care GTDP & International Trade EU & Other News Calendar
2 7 9 14 15-18 19 21
Members’ news
TER GROUP acquired ADIQUIMICA in Portugal and strengthened its position in Spain TER GROUP announces that TER AS PRODUCTOS S.L., subsidiary of the TER Chemicals Distribution Group, acquired from ADIGROUP their Portuguese company ADIQUIMICA and 100% of their Spanish division Paints-, Coatings and Construction, effective January 1, 2015. Christian Westphal, CEO of TER GROUP, mentioned: “With the addition of both businesses, Ter Group markedly improves its setup on the Iberian Peninsula. We warmly welcome thirteen new employees with extensive sales experience who will help us to grow sustainably. Furthermore we shall invest in continuous improvement of our systems and processes in Portugal and Spain.” Alexander Sielmann, managing shareholder of TER AS PRODUCTOS S.L., stated: “Through this acquisition more than twenty complementary distribution agreements have made our product portfolio in Spain even more attractive for clients in our defined focus industries. We do not foresee the need for changes in client allocation and will therefore continue to do what our customers are used to: taking care of them while providing excellence in service and technical support.” Source and information
Campi y Jové, S.A reached an agreement with the company LASENOR Campi y Jové, S.A has reached an agreement with the company LASENOR (Holdfood Group, Olesa de Montserrat, Barcelona) to acquire the production and commercialization activities of the emulsifiers GANDAK for the cosmetic and personal care sectors. This action is in line with the activity which Campi and Jové initiated two years ago of surfactant manufacturing in the Barbastro factory (Huesca, Spain) for the home, personal care and I&I cleaning sectors. The GANDAK line of products has a great complementarity with the products manufactured in Barbastro for all of the exportation markets which at present are being attended but wish to be reinforced more completely. Source and information.
Message from Mr. Panayiotis E.Koroneos, CEO at Synergy “Our participation in the FECC seals our commitment in upgrading the quality of our services in the sensitive sector of chemical Logistics and indicates the intention of the company to expand its business by offering tailor made solutions in line with European standards while monitoring developments and adopting best practices of the industry”.
Official opening of new Master Builders Solutions Training Center in Oldenburg The new Master Builders Solutions Training Center at BASF´s site in Oldenburg, Germany, has been officially opened. The opening ceremony took place in the presence of Ralf Spettmann, President of BASF´s Construction Chemicals Division, and Dr. Markus Kamieth, President of BASF´s Coatings Division. The new training center in Oldenburg has been created to train and inform customers and BASF´s Master Builders Solutions experts on the professional application and handling of Performance Flooring and Waterproofing products and systems – thus fostering their professionalism, knowledge and experience. Source and information
Members’ news
Safic-Alcan Acquires UK Distribution Responsibilities for Michelman’s Paper & Corrugated Coatings Safic-Alcan, an international distributor of speciality chemicals, has acquired distribution responsibilities for Michelman’s paper & corrugated coatings from Proman Coatings, a trading division of The Darent Wax Company in the United Kingdom. Philippe Combette, General Manager of Safic-Alcan, said: “With this agreement, we are now responsible for all distribution of Michelman’s paper & corrugated coatings in the United Kingdom. This is a landmark in our long-term relationship and continued loyal service and commitment to our global partner. This new distribution business will help strengthen the long existing business partnership between Safic-Alcan and Michelman.” “This development is consistent with our vision to expand our coatings business in Europe. Michelman has a strong and established presence in Europe and around the globe. The company’s European headquarters are in Luxembourg, and their manufacturing operations are in Belgium. With this new relationship with a global powerhouse, our goal is to make Michelman’s products a sustainable and profitable business both within and outside the United Kingdom,” concluded Philippe Combette. The Darent Wax Company, a UK-based distributor and wax manufacturer, had distributed Michleman’s paper & corrugated coatings brands including GlossCoat™, HydraBan®, Michem® Coat and VaporCoat® in the United-Kingdom. Tony Ward, CEO and founder of Darent Wax, determined that full distribution potential of Michelman’s paper & corrugated coatings would be best realised outside Darent Wax, and worked together with Michelman to transfer distribution to Safic-Alcan. Source and information
MARTIN UMBACH TO BE APPOINTED MANAGING DIRECTOR OF BIESTERFELD PLASTIC GMBH Effective from April 1st 2015 Martin Umbach was appointed Managing Director of Biesterfeld Plastic GmbH, a leading distributor for plastics and rubber located in Hamburg. Together with Carsten Harms, he is now responsible for the international operating subsidiary of Biesterfeld AG. “I am looking forward to developing the business activities of Biesterfeld Plastic GmbH and its subsidiaries together with Martin Umbach in the future. Biesterfeld Plastic will benefit from his operational experiences as well as his market and product know-how.”, states Carsten Harms, Managing Director of Biesterfeld Plastic GmbH and Member of the Executive Board of Biesterfeld AG. Martin Umbach (40) has been employed at Biesterfeld Plastic GmbH since 2001. He worked in product management until 2007 when he became Business Manager of the Business Unit Standard Polymers. Since then he has led the worldwide business activities of this expanding Business Unit which currently has an annual turnover of 200 Mio. €. As Managing Director of Biesterfeld Plastic GmbH he will take on additional duties with an operational focus on Germany. “I am looking forward to this new challenge. We have a great international team and are well-positioned to achieve our growths targets and the international expansion of Biesterfeld Plastic GmbH together.”, said Martin Umbach. Source and information
Biesterfeld Spezialchemie expands the distribution of DIC Performance Resins products in Turkey Austria’s DIC Performance Resins GmbH has appointed Biesterfeld Spezialchemie GmbH as distributor of their specialty resins products for the Turkish market. Biesterfeld Spezialchemie already distributes DIC Performance Resins product portfolio of innovative, aqueous and solvent-free as well as traditional solvent-based specialty resins in 19 European countries. For more than 100 years DIC Performance Resins has been producing high-quality resins for the use in paints, coatings, printing inks and adhesives formulations. Read more
Members’ news
Omni-Chem136, LLC Announces HARKE GROUP as New European Member Omni-Chem136, LLC the world’s largest alliance of regional independent chemical distributors with 18 member companies, more than 145 facilities and $3.0 B of combined sales announces that HARKE GROUP of Germany, a leading chemical distributor and a wholly owned private company, has joined the alliance effective February 1, 2015. HARKE GROUP of Mülheim an der Ruhr, Germany was ranked worldwide no. 84 in the ICIS Top 100 Chemical Distributors for 2014. “The addition of HARKE GROUP to our alliance is another significant step forward in our strategy to build a global chemical distribution alliance”, says Fred A. Buehler, Managing Director Omni-Chem136. “HARKE GROUP is a world class distribution company with operations that adhere to the highest standards of responsible distribution. We are delighted to have HARKE GROUP as part of our alliance and are excited about the continued global expansion of Omni-Chem136.” As an international distributor with subsidiaries and sales offices throughout Europe, HARKE GROUP opens industrial sourcing and sales markets for its customers and suppliers in Europe and around the world. The product portfolio of the group includes industrial, specialty and high purity chemicals, plastic additives, plastic raw materials and plastic products, high quality pharmaceutical excipients, food additives and ingredients, dietary supplements and ingredients for the personal care and clean care industries. In addition, HARKE GROUP offers related services such as contract packing, mixing and blending, legal consulting and representative services concerning EU chemical (REACH), pharmaceutical and food legislation. Founded in 1965 as SYNTANA, HARKE GROUP has evolved through steady growth and consistent expansion into a diversified business group with a contract packing, mixing and blending facility in Bochum, subsidiaries in Brussels, Budapest, Bucharest, Istanbul, Milan, Moscow and Warsaw and liaison offices in Nanjing, Nuremberg and Paris. “Our membership in Omni-Chem136 extends our network in the chemical manufacturing and chemical distribution industries, opening new sourcing and sales channels that will benefit both – our customers and suppliers”, says Thorsten Harke, President HARKE GROUP. “We are excited to be a member of Omni-Chem136’s prestigious global alliance of regional independent chemical distributors.” Source and information
Caldic completes acquisition of The Ingredient Company Enhancing product offering and creating high-end ingredient solutions for our customers Caldic B.V., international distributor and producer of food ingredients, chemicals and technical products has completed the acquisition of The Ingredient Company, a leading distributor of savoury and nutrition ingredients in Canada. The completion of this agreement underlines Caldic’s strong position and aspiration to become a leading North American food ingredient solution provider using its distribution and manufacturing capabilities. The acquisition also strengthens its flavour and natural ingredient solutions beyond its current activities in North America. The Ingredient Company has years of experience offering food ingredients which provide flavour and functionality in finished products to food manufacturers. The product portfolio contains flavours, spice extracts, condiments, gelatine and natural fruits and vegetables which are seen as very complementary to the existing Caldic range. The acquisition of The Ingredient Company will further enhance Caldic’s established expertise and product offering in the Savoury and Nutrition market sectors. According to Mr. Olav van Caldenborgh, CEO of Caldic B.V., the combination of The Ingredient Company and Caldic “makes us an even more strategic business partner to our customers and forms another pillar for potential growth for our company”. Mr. Al Frittenburg, CEO of The Ingredient Company, is pleased about this acquisition: “I believe that Caldic and The Ingredient Company share the same customer focus and desire to bring high quality products and solutions to our customers, I trust Caldic will help us to expand our strong position in North America and this will be very positive for our valued suppliers and customers.” Source and information
Members’ news
IMCD and MÜNZING CHEMIE announce extension of partnership to India IMCD N.V. and MÜNZING CHEMIE announce they have further expanded their successful partnership for the distribution of coating additives to India. Effective immediately, this new agreement is the extension of an existing partnership in Australia, New Zealand and Italy as well as in Serbia, Croatia, Slovenia and Bulgaria for waxes. IMCD will serve customers in the architectural, decorative paints, industrial coatings, adhesives, printing inks, wood coatings, emulsion polymerization and pigment paste markets across India. Silke Wetzig, Business Development Manager Coatings at IMCD, comments: “This is a great opportunity for IMCD to build on its partnership with MÜNZING CHEMIE and enhance its offering to the coatings market in India. We are confident that this expansion will further strengthen our presence in an exciting market whilst we continue to deliver a first-class service to MÜNZING CHEMIE.” The MÜNZING CHEMIE coating additives range includes liquid defoamers, rheology modifiers, wetting and dispersing agents, levelling agents, emulsifiers, open time additives, crosslinkers, release agents, hammerfinish additives and liquid matting agents. Source and information
IMCD acquires Kushalchand in India IMCD N.V., a global leader in the sales, marketing and distribution of speciality chemicals and food ingredients, announces that it has completed the acquisition of Kushalchand Sons in India. Kushalchand, a family owned company based in Mumbai since 1922, is a distributor of food speciality ingredients to the fast growing processed food industry in India and represents world class suppliers. With a goal to provide the food industry with a single stop solution for all their clients' formulation needs, Kushalchand has been at the forefront of food ingredients distribution in India. The acquisition of Mumbai-based distributor provides a platform for the further strengthening and expansion of the activities of IMCD in the food market in India. Mr Amit Hirani, former owner of Kushalchand and the new Business Director of IMCD India, comments on the transaction: "IMCD and Kushalchand share a common strategy through providing the Indian food industry with a wide range of key ingredients from world leading manufacturers. This synergy will enable IMCD to further strengthen their presence on the
Indian market." Kushalchand generated revenue of approximately EUR 9 million. Its business will be integrated into IMCD India whilst 18 employees have already transferred to IMCD. Source and information
VELOX offers TOLSA range of FR synergists in Europe VELOX, a European leader in the marketing and supply of raw material specialities for the plastics, composites, rubber, paints and coatings industries, is delighted to announce their partnership extension with the Spanish TOLSA Group. This new cooperation implies that VELOX will distribute ADINS ® Clay and ADINS® Fireproof series, great ranges of flame retardant synergists, in Europe. VELOX is proud to partner with Tolsa Group, a leading supplier of high-performance flame retardant and thermal insulation synergists. Claudia Fath, Product Manager at VELOX comments: “The ADINS ® range of additives are based on a breakthrough technology using natural silicates, offering tailored performance benefits, improved processability, and reduced cost. The ADINS ® range of additives combines a very high surface area and special morphology with a tailored functionalization which provides adaptable solutions for wire and cable as well as electronics uses. With sepiolite as a carrier, the flame retardant dosage can be reduced, thus decreasing the overall cost.” Read more
Members’ news
Barentz International acquires leading distributor Astabumi of Indonesia Barentz International announced that, following its recent capital injection to accelerate growth, it has acquired PT Astabumi Ciptadaya, a leading distributor of specialty ingredients for the Food & Nutrition industry in Indonesia. Barentz, a leading international food ingredients distributor, calls this acquisition in Indonesia a logical step in the strong expansion of Barentz in the Asia Pacific region. Indonesia is what Barentz calls a “promising market”. With a population of 245 million people, a growing economy and a rapidly expanding middle class, the market for processed foods and more sophisticated food & nutrition products is growing, calling for innovative ingredients following trends in Europe and the USA. Headquartered in Jakarta, Astabumi services customers in the food, beverage, confectionary, nutrition, health and well-being sectors across Indonesia. For Barentz International, headquartered in The Netherlands and active in close to 50 countries across three continents, the acquisition of Astabumi is strategically important, with Indonesia being the largest economy in South East Asia. Barentz itself has been active under its own brand in Indonesia since 2012. Astabumi and Barentz will integrate their business over the next couple of months and will continue to operate with both trading names, under the legal entity PT Barentz Indonesia. Representing world class suppliers of ingredients, Barentz is active in nine countries in the region, namely in Australia, New Zealand, India, Indonesia, Malaysia, Singapore, Philippines, Vietnam and Thailand. Read more
Banner Chemicals wins Health, Safety and Environment Award 2M HOLDINGS, RUNCORN, UK, MARCH 2015 Banner Chemicals, one of 2M’s subsidiaries, has won the Health, Safety & Environment Award from Chemicals Northwest. The award is for Banner Chemicals’ special initiative in ensuring safer packaging practices along the supply chain, in accordance with the ADR regulations for appropriate ullage space, preventing overfilling in transit or storage. The initiative goes further than regulatory requirements, by extending the principles to chemicals that are not classified as hazardous. This extension is in line with 2M Group’s mission to improve the public perception of the Chemical Industry.
Banner’s initiative has included writing guidelines for the Solvent Industry Association, to ensure smaller businesses also have access to Best Practice information with examples of commonly used solvents in different drum sizes. David Dalton, Group Compliance Director for Banner Chemicals and its parent company, 2M Holdings Ltd, said: “We are all ambassadors for the Chemical Industry and take Health and Safety very seriously – it is our responsibility to share our expertise where we can and we work extensively with the SIA and other organisations to do that.” Source and information
Lubrizol Award for Added Value Distribution for Surfachem Lubrizol Corporation presented Surfachem Ltd (part of 2M Holdings Ltd, www.2m-holdings.com) with the prestigious Added Value Award during the latest distributors' meeting at Incosmetics 2015 in Barcelona. The award is in recognition of Surfachem's outstanding commitment to excellence and innovation. Lubrisol acknowledge Surfachem's sustained efforts in delivering added value to business partners across various products and applications. Dr Richard Smith, Managing Director of Surfachem, said: "This Award is a testament to the expertise of the Surfachem team. We are delighted to work with our principals bringing innovation to the chemical markets we operate in, and will continue using Surfachem capabilities to promote Lubrizol as an added value company with innovative solutions". Source and information.
Members’ news
BASF and Grolman collaborate in Europe Marketing of Baxxodur curing agents for use in epoxy resin systems Used in floor coatings, corrosion protection varnish and composite materials Effective immediately, BASF and Neuss/Germany-based Gustav Grolman GmbH & Co. KG will start an exclusive collaboration in the marketing of amine-based curing agents of the Baxxodur® brand in Europe. Grolman will initially market the BASF specialty chemicals for the countries of Germany, Austria, Switzerland, Belgium, the Netherlands, Luxembourg, Ireland and Great Britain, specifically for use in epoxy resin based applications. Examples are thermosetting laminates, highly resistant floor coatings, corrosion protection varnish and composite materials. The products are used in the construction industry as well as in the automotive, marine, aerospace and industrial applications manufacturing. “The partnership fits very well into our Baxxodur sales & distribution strategy. Grolman has a diversified know-how in application technology and a technically well-versed sales force. As one of Europe's largest distributors of specialty chemicals, Grolman also has the right structure and market acceptance to serve customers efficiently,” says Dr. Oliver Cullmann, Vice President Business Management Specialty Amines in BASF's Intermediates division. “The high-quality curing agent components made by BASF supplement to a great extent our product range of resins, accelerators, flame retardants, fiber and filler wetting agents not only for the thermosetting industry, but also allows us to keep expanding our strong position in the coating industry,“ says Dirk Grolman, Managing Director and owner of Grolman GmbH & Co. KG. Under the brand name Baxxodur, BASF markets a diversified spectrum of amine-based curing components for the professional processing of epoxy resins. In addition, the BASF product range also comprises various systems of epoxy resins and curing agents. Source and information
Fecc Activities
Fecc welcomes Marie-Hélène Laplagne as New Administrative Assistant We are pleased to inform you that Marie-Hélène Laplagne has joined Fecc as the New Administrative Assistant Marie-Hélène brings more than six years of experience working as as a Management Assistant at Cefic. She obtained her Office management diploma at the ECSEDI University in Brussels and speaks French and English. She is also a proud mom of two children and married. We would like to extend a warm welcome to Marie-Hélène !
STANHOPE HOTEL DISCOUNT—10% OFF ! Go to : http://www.thonhotels.com/log-in/ Benefit from 10% reduction on their Best Available Rate in all of their Brussels Hotels Customer number: TH21779613 Company name: FECC
Fecc Activities
Fecc Annual Congress 2015 – 2 weeks to go! Register today and don’t miss your opportunity to network with the Top Leaders of the chemical distribution industry. We anticipate that the Fecc Congress will be packed with engaging and informative discussions on critical issues. The programme with its theme “Towards a Sustainable Future” features a broad range of speeches that will stimulate an exciting exploration of important issues in the chemical industry. To register, go to: www.fecc-congress.com 2015 Sessions & Highlights Does size matter? Success factors in the chemical distribution Global Perspective of the Chemical Distribution Market New Developing Markets How to plan for the long-term? Sustainability, putting it in perspective Compliance and Communication in the Supply Chain
Opening Reception, Grande Bretagne Hotel, Rooftop Terrace
Marc Woods, Gold Medallist Paralympic and ex-cancer survivor
ALM International S.A joins Fecc ! Brussels, April 2015 –The European Association of Chemical Distributors (Fecc), the voice of the European chemical distribution industry,is pleased to announce that ALM International S.A has recently joined the association. Fecc is proud to welcome its new member, ALM International S.A., a whose main activities are water treatment, distribution and marketing of chemicals and agrochemicals in Sub-Saharan Africa, through a network of subsidiaries and local distributors. Fecc constantly strive to further improve membership benefits and increase the number of services offered by our office. Developing our membership is a priority for us; we believe that working together is the way to drive our industry towards success. ALM International has been an expert in the distribution of chemicals and agro-chemicals on the African territory for over 30 years. In order to establish its image and skills, ALM International has chosen to work along with some of the major chemical players in the world: BASF, DOW CHEMICAL, ERCROS, PT LAUTAN, SASOL, SOLO, TOSOH ... Through its network of subsidiaries and local distributors, ALM International has developed its activity on the African market. This expansion is part of a broader development of ALM International in Africa and therefore allow high quality local service. All subsidiaries, wholly owned by ALM International, have two main goals:
To distribute its products and bid for local tenders
To collect information in the country and forward it to the parent company that will be in a position to have a better assessment of the local context in order to develop its sales and introduce new products.
Their subsidiaries are present in:
Ivory Coast - ALM AO Cameroon - AGROCHEM Burkina Faso - SENEFURA SAHEL Gabon - AD CHIM Democratic Republic of Congo - ALM RDC For more information: http://www.alm-inter.com/en
EU Chemicals Legislation
Registry of Intentions updated It is of paramount importance that industry keeps an active eye on the intentions of Members States with regard to: SVHC, CLH and restrictions. Therefore you will find below a summary of the new intentions recently introduced. Restriction New intentions: The four classified phthalates (bis(2-ethylhexyl) phthalate (DEHP), benzyl butyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP)) in articles SVHC New intentions: Dicyclohexyl phthalate (EC 201-545-9) from Sweden New proposal: · 1,2-benzenedicarboxylic acid, di-C6-10-alkyl esters; 1,2-benzenedicarboxylic acid, mixed decyl and hexyl and octyl diesters with ≥ 0.3% of dihexyl phthalate (EC No. 201-559-5) · 5-sec-butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [1], 5-sec-butyl-2-(4,6dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [2] [covering any of the individual isomers of [1] and [2] or any combination thereof] CLH New intentions: · 1-vinylimidazole (EC 214-012-0) · nitric acid ... % (EC 231-714-2) New withdraw: · Of the intention to re-submit 25 harmonised classification and labelling dossiers for Straight Chain Lepidopteran Pheromones (SCLP) covering alcohols, aldehydes and acetates groups. These are active substances in plant protection products. New submitted proposals: · hymexazol (ISO); 3-hydroxy-5-methylisoxazole (EC 233-000-6) submitted by Finland · Sodium hypochlorite (EC 231-668-3) submitted by the Netherlands · Acetaldehyde (EC 200-836-8) submitted by the Netherlands · Flutianil (ISO) (CAS 958647-10-4) submitted by the United Kingdom · Isoproturon (ISO) (EC 251-835-4) submitted by Germany · 1,2-dihydroxybenzene; pyrocatechol (EC 204-427-5) submitted by France
EU Chemicals Legislation
Forum starts a pilot project on authorised substances At its twentieth plenary meeting on 24-26 March 2015, the Forum for Exchange of Information on Enforcement decided on a second pilot project on the use of substances subject to authorisation. It will focus on substances with a sunset date before 2016. In addition to enforcing that substances subject to authorisation are not on the market without an authorisation, the inspectors will also check whether the authorisation holders comply with the conditions of the granted authorisation. The inspections will target manufacturers, importers, other suppliers and downstream users of substances subject to authorisation. This includes authorisation holders and their downstream users. The results are expected at the end of 2016. The Forum also decided to choose specific restriction entries for the fourth coordinated enforcement project. The entries will be chosen so that they are relevant for consumer articles, professional use and protection of the environment. Each Member State will be free to choose restrictions which are most relevant to their national priorities and market situation from a list of entries. That list will be published in the second quarter of 2015. Inspections will then take place during 2016 and the final report will become available in 2017.
ECHA publishes list of pending Article 95 applications In order to increase transparency ahead of the 1 September 2015 deadline for compliance with Article 95 of the Biocidal Products Regulation (BPR), ECHA publishes a list of all pending Article 95 applications. The list which contains applications for which ECHA has not yet taken a decision will be updated regularly and its publication will be synchronised with the list of active substances and suppliers (the "Article 95 list"). List of pending applications | List of active substances and suppliers
Four new practical guides clarify data sharing under the biocides regulation ECHA launches a new special series of practical guides on data sharing, which provide hands-on advice to companies dealing with biocides. Biocides Practical Guides | Article 95 web pages
EU Chemicals Legislation
How to identify complex substances in REACH? 27-28 April 2015, Brussels The European Commission organises a two-day workshop focusing on the challenges companies have in identifying complex substances for REACH registration. The event will bring together stakeholders such as REACH consortia, industry associations and individual registrants as well as competent authorities, the national REACH helpdesks, ECHA and the European Commission. All organisations whose members need to know about identification of complex substances under REACH are invited to participate and to contribute to the discussions. The workshop will be web streamed (see link below). The video recording as well as presented material will be available on the European Commission's website after the event. Workshop
Biocides Stakeholders' Day Registration open 1 September 2015, Helsinki Biocides Stakeholders' Day will take place on 1 September, which is the three-year anniversary of the entry into operation of the Biocidal Products Regulation (BPR). The programme will focus on case studies and experiences from companies. There will also be presentations on the regulation and available tools and support. The day is open to all and the content will be of particular relevance to European and national trade associations, SMEs, large companies, alternative suppliers and environmental as well as health NGOs. Online registration is now open. There are a limited number of places available on a first-come, first-served basis; so register now to ensure yours. Event page | Register
Tenth Stakeholders' Day conference, 27 May 2015, Helsinki This year, we will hear best practice from a wide range of experts from industry, Member States, NGOs and ECHA. The three plenary sessions are the following: "REACH 2018", "Improving dossier quality" and "Risk management". As before, participants can also book one-to-one sessions with ECHA's scientific experts to discuss specific topics and receive advice. Participation to the conference is free of charge. The conference will be web-streamed live and a link to join the broadcast will be available on the ECHA home page on the morning of the event. Registration is open until 1 May or until places run out. Register | List of speakers | Event page
EU Chemicals Legislation
Top tips for the CLP 2015 deadline Do you know what you need to do to comply with the Classification, Labelling and Packaging (CLP) Regulation? Are you aware of the impact the CLP deadline on 1 June 2015 has on your company? ECHA Newsletter has gathered some frequently asked questions related to the CLP deadline to help you in your preparations. The CLP Regulation requires hazardous chemicals to be classified, labelled and packaged appropriately before they are placed on the market. The regulation is based on the United Nations' Globally Harmonised System (GHS) and replaces in a stepwise manner the previous legislation – the Dangerous Substances Directive (DSD) and the Dangerous Preparations Directive (DPD). Now is the time to act to make sure that you comply with CLP. See: http://newsletter.echa.europa.eu/home/-/newsletter/entry/6_14_top-tips-for-the-clp-2015deadline
Are you a notifier? Then agree on the classification and labelling of your substances In collaboration with the European Commission, Cefic, Eurometaux and FECC, ECHA launched a pilot project to encourage notifiers to agree on the classification and labelling of substances. The notifiers of approximately 100 substances were contacted and asked to compare the notifications they have made with the harmonised classification or with the notifications provided by other notifiers, as published in the C&L Inventory. If there is a disagreement on the self-classification, the parties are invited to use ECHA’s web-based discussion forum, the C&L Platform, where notifiers and registrants of the same substance can come into contact and agree on a self-classification and labelling of their substance. In the first three weeks of the exercise, already more than 30 of these discussions have been initiated on the pilot project substances. The registrants and notifiers of other substances are also invited to check the notifications and where needed to use the C&L Platform. C&L Platform | C&L Inventory
For more information on Chemicals Legislation, please contact: Ophélie Roblot +32 2 679 02 68 oro@fecc.org
EU Chemicals Legislation
Cefic European Responsible Care Awards 2015: Call for Entries Deadline for Submission: 1 July 2015 Apply for the 10th "European Responsible Care Awards" 8 Responsible Care categories, 3 winners!
The 10th edition of the "European Responsible Care Awards"competition is now open. Take part in the competition and showcase your work to the people that matter! * Do you believe your organisation deserves increased visibility for its commitment and accomplishments in applying the Responsible Care principles? * Are you keen to present your efforts and achievements that are actively contributing to the Responsible Care objectives? * Do you consider your project outstanding? Entries will be considered by an expert jury of senior representatives from EU institutions, industry, trade associations and media. Our judges are Responsible Care thinkers and doers; even if you don’t win, this is a great way to make them aware of your work. Download your application form.
Deadline for submission: 1 July 2015 Managed by Cefic, this Awards have a high profile in highlighting our industry's commitment to sustainability vis-Ă -vis our European stakeholders. They will also shine a light on outstanding national association and company achievements, based on the eight areas embracing the Responsible Care ethic. The Responsible Care Awards will be announced and presented during our General Assembly Dinner in Brussels on Thursday, October 8th, 2015. Please promote the awards competition among your members, take part in the competition and showcase your work to the people that matter! www.cefic.org/Responsible-Care/Awards/
For further details, please contact Gerhard Ahlbrecht (gah@fecc.org)
Responsible Care and Logistics
Fecc Survey 2015 Launched in February Fecc is pleased to announce that the Survey 2015 (Data 2014) is open now.
Please submit your data before MAY 15th 2015. If you need help in completing the survey, please contact Gerhard Ahlbrecht (gah@fecc.org). NB: We would like to emphasize that the web form cannot be used after the deadline indicated above as Adobe plans to retire FormsCentral, the platform for our survey, this summer. This means that you are technically obliged to use the PDF form after May 15 2015. Thank you for your cooperation!
New Version of the Fecc European Responsible Care Programme Approved and Available on Fecc’s Website In case of questions, please contact Gerhard Ahlbrecht (gah@fecc.org).
Fecc Product Stewardship Committee At the last Product Stewardship Committee meeting the question was addressed about how to revitalize the Committee, especially noting how the number of members decreased during the last few years. It has been suggested that the Committee should dedicate more energy exploring issues that can be of particular interest to actors in the supply chain especially manufacturers and produce documents such as best practices or guidelines in those fields. We therefore are asking you to provide some ideas on topics that could be of interest and on which the Product Stewardship Committee could raise awareness and provide clarifications, for example writing specific guidelines. Please send your suggestions and ideas to Gerhard Ahlbrecht (gah@fecc.org)
For more information on Responsible Care and Logistics , please contact: Gerhard Ahlbrecht at +32 2 679 02 64 gah@fecc.org
GTDP
API and Excipients - New guidelines published The guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use have been published. A risk assessment as set out in these guidelines should be carried out for excipients for authorised medicinal products for human use by 21 March 2016. Also the guidelines on principles of Good Distribution Practice of active substances for medicinal products for human use have also been published and come into operation on 21 September 2015.
Source: DG Sanco - http://ec.europa.eu/health/documents/new_en.htm
Commission report on the use of delegated powers The Commission transmitted to the European Parliament and the Council a report on the use of delegated powers provided by the EU pharmaceutical legislation. This follows a legal obligation under Directive 2001/83/EC and Regulation (EC) No 726/2004, which requires the Commission to prepare such report every five years.
International convergence: Australia’s TGA proposes to adopt 10 EMA guidelines In a sign that pharmaceutical regulators are merging their regulations further, Australia’s TGA (Therapeutic Goods Administration) is seeking to adopt 10 EMA (European Medicines Agency) guidelines on quality, biologics, clinical efficacy, safety, and more. Source : in-pharmatechnologist - http://www.in-pharmatechnologist.com/Regulatory-Safety/Internationalconvergence-Australia-s-TGA-proposes-to-adopt-10-EMA-guidelines
EMA: TTIP and inspection databases a way of improving global manufacturing standards Ensuring drugs, APIs and excipients are safe will be a focus for the EMA, which says it will explore supplier inspection databases and using trade deals like TTIP to promote GMP standards globally. Source : in-pharmatechnologist - http://www.in-pharmatechnologist.com/Regulatory-Safety/EMA-TTIP-and-supplierdatabases-can-improve-drug-standards-globally
GTDP
EU GMP: Final Annex 15 now published The currently valid version of the EU GMP Guide Annex 15 “Qualification and Validation� from 2001 will finally be replaced by 1 October 2015. This is when the now published revised Version of Annex 15 will enter into force. The new principles of ICH Q8, Q9, Q10 and Q11 constituted a new regulatory environment but also a continuous updating of Chapters of Part I of the EU GMP Guide or Annex 11 (computerised systems). Another important document to be mentioned in connection with the new Annex 15 is the EMA guidance on process validation. The changes now reflect the changed regulatory requirements and the latest state of technology in the pharmaceutical industry. Source: GMP Publishing - https://www.gmp-publishing.com/en/gmp-news/gmp-aktuell/EU-GMP-final-annex-15-october2015.html
Indian Pharmacist Group Calls for Stricter Regulations on Storage Temperature Instructions A group representing pharmacists in India is calling for regulators to amend the country's Drugs and Cosmetics Act to more strictly control how manufacturers specify temperature storage instructions for their products. Background The environment drugs and other healthcare products are stored in plays a critical role in ensuring their safety and efficacy. Manufacturers are required to control for a number of environmental factors, including temperature, humidity, ventilation and exposure to sunlight, based on their product's sensitivity to those factors. Because the risks posed by improper storage do not vanish after a product leaves the manufacturer, companies must also consider how their products are distributed, warehoused, stored at pharmacies and ultimately how they are handled by consumers. The requirements for controlling environmental factors are often found in good manufacturing practice (GMP) and good distribution practice (GDP) guidelines. In 2013, India released a draft of its Guidelines on Good Distribution Practices for Pharmaceutical Products, which has yet to be put into effect. However, neither the draft guidelines nor the Drugs and Cosmetic Act establish specific requirements on how storage temperature instructions must be written. Source: RAPS News - http://www.raps.org/Regulatory-Focus/News/2015/04/20/22003/Indian-Pharmacist-Group-Calls-forStricter-Regulations-on-Storage-Temperature-Instructions/
EMA Says Complying With its Scientific Advice Raises Likelihood of Approval, Fewer Objections companies that request scientific advice, the agency offers A new study authored by European Medicines Agency (EMA) staff finds that companies that followed the agency's scientific reduced fees to certain products, including orphan medicinal products and advanced-therapy medicinal products (ATMPs). advice are more likely to get their products authorized. Products with a pediatric use designation may receive scienEMA provides scientific advice to companies for a fee in order tific advice free of charge. Additionally, small- and mediumto assist them in designing clinical trials through its Scientific sized enterprises (SMEs) qualify for reduced fees through the Advice Working Party (SAWP). If a clinical trial I SME office. is not well designed, it can be difficult to for the agency to Source: RAPS News - http://www.raps.org/Regulatory-Focus/ conduct an assessment of the product and may lead to objecNews/2015/04/20/21997/EMA-Says-Complying-With-itstions from reviewers. While EMA collects fees from Scientific-Advice-Raises-Likelihood-of-Approval-FewerObjections/
GTDP
To Boost Transparency, Canada Launches GMP Inspection Database Canada's Health Minister Rona Ambrose announced the launch of a new publicly accessible database for manufacturing inspections on 13 April 2015. The new Drug and Health Product Inspection Database will allow Canadians to search for timely information on good manufacturing practice (GMP) inspections conducted by Health Canada.
Source: RAPS News - http://www.raps.org/Regulatory-Focus/News/2015/04/15/21975/To-Boost-TransparencyCanada-Launches-GMP-Inspection-Database/
India’s CDSCO Issues Guidance on How to Conduct GMP Inspections India’s Central Drugs Standard Control Organization (CDSCO) issued a notice to all local State Drugs Controllers setting forth uniform procedures on how to conduct good manufacturing practice (GMP) inspections of local pharmaceutical manufacturing facilities. Local inspectors are to focus on the GMP requirements for establishing shelf life, validation studies, and ensuring prompt recalls of non-compliant products when necessary.
The inspection should last between two and five days (depending on the size and complexity of the manufacturing site) and regulatory action is to be undertaken immediately in those cases where inspection observations have uncovered conditions that could compromise drug quality, safety and efficacy. CDSCO also states that the report of the inspection findings that prompted regulatory action should be finalized without delay at the end of the inspection. Source: RAPS News - http://www.raps.org/Regulatory-Focus/News/2014/08/08/19995/India%E2%80%99sCDSCO-Issues-Guidance-on-How-to-Conduct-GMP-Inspections/
International Trade
New report shows major potential of TTIP for smaller companies The Transatlantic Trade and Investment Partnership (TTIP) has significant potential for small and medium sized enterprises, according to a report released in Brussels. It presents the results of a survey of small and medium-sized enterprises (SMEs) carried out in 2014 on challenges they face when exporting to the United States. It also uses newly available data to look at the scale of exports by EU SMEs to the United States.
The report finds that SMEs are already big winners from transatlantic trade. 150,000 SMEs exported to the United States in 2012, accounting for 28% of all EU exports there. SMEs in sectors linked to food, beverages & agriculture; clothing, textiles & leather; as well as chemicals had an above-average share of EU exports. However, the survey also shows that that EU SMEs see challenges in exporting to the US market, many of which can be eased by a TTIP agreement that is ambitious and comprehensive and maintains our high standards of regulatory protection. Source: DG Trade - http://trade.ec.europa.eu/doclib/press/index.cfm?id=1292
EU and Vietnam hold twelfth round of FTA talks The EU and Vietnam completed the twelfth round of talks on the Free Trade Agreement (FTA). This time the talks were held in Hanoi, Vietnam, from 23 to 27 March 2015. Both teams made further progress on finding common ground on all open issues, and are continuing to work towards a swift conclusion of the negotiations.
The talks focused on the outstanding areas of the proposed FTA such as goods (tariffs, rules of origin, non tariff barriers, export duties), services & investment, government procurement, state owned enterprises, IPR and geographical indications, and regulatory issues. Source: DG Trade - http://trade.ec.europa.eu/doclib/press/index.cfm?id=1286
For more information on International Trade, please contact : Joel D’Silva +32(0)2 679 02 62—jds@fecc.org
EU & Other News
Investment Plan for Europe: Poland will also contribute € 8 billion On April 21, 2015 - Poland announced that it will contribute €8 billion to projects benefiting from finance by the European Fund for Strategic Investments (EFSI), which is at the heart of the €315 billion Investment Plan for Europe. The contribution will come via its National Promotional Bank Bank Gospodarstwa Krajowego ("BGK"). Poland is the sixth country to contribute to the Plan even before the EFSI has been formally set up, following the lead of Germany, Spain, France, Italy and Luxembourg. European Commission Vice-President Jyrki Katainen, responsible for Jobs, Growth, Investment and Competitiveness, said: "I am very glad to receive the great news from Finance Minister Mateusz Szczurek in person that Poland will contribute to the Investment Plan, the sixth country to do so. Poland's BGK already has a vast engagement in cross-EU investment platforms. I am very happy about this very timely announcement." Background On 10 March, EU finance ministers agreed a common position on the Commission’s proposal for a Regulation on the European Fund for Strategic Investments (EFSI). Following a vote on the Regulation by the responsible Committees in the European Parliament on 20 April, negotiations between the co-legislators can now enter the final phase, with a view to finding an agreement on the legal text in June. Already by the summer, SMEs and some infrastructure projects will be able to benefit from pre-financing from the EIB, as was announced on 17 February. The objective is that the new Fund will be fully operational by September at the latest. National Promotional Banks have a crucial role to play in getting Europe investing again. They have the expertise to carry out the Investment Plan, and they often ensure the most efficient use of public resources. Poland is now the sixth country to announce a contribution through its National Promotional Bank: Germany announced in February that it would contribute €8 billion to the Investment Plan through KfW. Also in February, Spain announced a €1.5 billion contribution through Instituto de Crédito Oficial (ICO). In March, France announced a €8 billion pledge through Caisse des Dépôts (CDC) and Bpifrance (BPI) and Italy announced it will contribute €8 billion via Cassa Depositi e Prestiti (CDP). In April Luxembourg announced that it will contribute €80 million via Société Nationale de Crédit et d’Investissement (SNCI). The economic crisis brought about a sharp reduction of investment across Europe. That is why collective and coordinated efforts at European level are needed to reverse this downward trend and put Europe on the path of economic recovery. Adequate levels of resources are available and need to be mobilised across the EU in support of investment. There is no single, simple answer, no growth button that can be pushed, and no onesize-fits-all solution. The Commission is setting out an approach based on three pillars: structural reforms to put Europe on a new growth path; fiscal responsibility to restore the soundness of public finances and cement financial stability; and investment to kick-start growth and sustain it over time. The Investment Plan for Europe is at the heart of this strategy. More information: Investment Plan Website
EU & Other News
UPCOMING EVENTS 11th annual Innovation fusion: NPD & Technology Excellence for Chem & FMCG Sectors that will take place in April 21& 22 in Berlin Innovation Fusion programme Innovation Fusion webpage
TSGE Forum - The European REACH Congress Düsseldorf, Germany, 24-25 November 2015 Find out more on: http://www.reachcongress.com/
Food Matters Live takes place at London’s ExCeL on Tuesday 17 – Thursday 19 November 2014 which will tackle one of the most important issues of our time – the relationship between food, health and nutrition. With several FECC members already involved, see the website to find out more. www.foodmatterslive.com @FoodMattersLive
Calendar Date
Meeting
Location
2015 April 23
ESAD Steering Committee
Cefic, Brussels
5
BOARD Meeting
Athens
6
Internal Meetings
Athens
6-8
Annual Congress
Athens
27
GTDP
Brussels
28
International Trade
Brussels
Responsible Care
Brussels
SHE Committee
Brussels
8
Responsible Care
Brussels
23
BOARD Meeting
Hamburg
29
ESAD Steering Committee
Fecc, Brussels
21
SHE Committee
Brussels
22
GTDP
Farmalabor, Italy
17-18
EXCiPACT Training
Brussels
25
Membership Meeting
Hilton (Grand-Place), Brussels
25
BOARD Meeting
Brussels
26
International Trade
Brussels
Responsible Care
Brussels
May
June 10 July 29 September
October
November
December 3
Contact us! Fecc secretariat +32 2 679 02 60 Uta Jensen-Korte, Director General—ujk@fecc.org Alexandra Mengesha, Communications & Membership Development Manager—ame@fecc.org Gerhard Ahlbrecht, Responsible Care and Logistics Manager—gah@fecc.org Joel D’Silva, Life Science & International Trade Manager—jds@fecc.org Ophélie Roblot, Health Safety & Environment Manager—oro@fecc.org Marie-Hélène Laplagne, Administrative Assistant—assistantfecc@fecc.org
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