Fecc Newsletter April 2014

Inside

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click a web ble links

2 Members News 6 Fecc Activities

newsletter

10 GTPD 12 International Trade 12 EU & Other News

issue 4 - April 2014

Registrations are now open! For the Fecc Food Safety workshop: How to Comply as a Chemical Distributor

Fecc Annual Congress Register Today!

Over 130 companies and over 210 delegates have already confirmed their presence, don’t miss out and register today! Want to know who will be there? visit: www.fecc-congress.com/who

Join us to celebrate Fecc’s 60TH Anniversary - With a Longer Opening Reception 19:00-22:00

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raceability… Food Grade… HACCP… BRC…? Want to know more…. Join us in our 2014 Fecc Product...

Read more on page 6

The Biocidal Products Committee adopts its first opinions

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he Biocidal Products Committee Please join us for a full evening of networking to celebrate 60 years of working (BPC) met from 8 to 10 April 2014. together. Attending the Opening Reception is a great start to the congress. Enjoy The first three opinions adopted were three hours to meet fellow delegates in a unique setting. We will celebrate this in relation to industry applications... important occasion on the rooftop pool of the Radisson Blu hotel with cocktails and walking dinner.

Read more on page 9 If it is the first time you are joining the Fecc Congress for the first time, please join us for a first time delegates reception at the rooftop pool of the Radisson Blu hotel at 18:30 (Monday 26).

Register today on:

www.fecc-congress.com Scan this QR code to download the congress mobile app:

European Medicines Agency (EMA) presents report to the Commission on pharmacovigilance

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he European Medicines Agency (EMA) has presented the European Commission with its first report on the tasks it undertook...

Read more on page 10

Sponsored by:

EU adopts stronger rules to better defend its rights under trade agreements

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he European Commission welcomes a new legal framework approved by the European Parliament on April and by the EU Council to....

Read more on page 13 www.fecc.org

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Members News AkzoNobel and Solvay seal partnership with EY to monitor sustainable raw material use

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kzoNobel and Solvay have joined forces with EY (Ernst & Young) to jointly develop a monitoring system that tracks and quantifies the use of renewable raw materials in paints, coatings and other applications.

The partnership builds on last year’s agreement between AkzoNobel and Solvay, whereby the company progressively increases the use of Solvay’s bio-based epichlorohydrin, or Epicerol, in its coatings products. Rather than buying Epicerol directly from Solvay, AkzoNobel obtains epoxy resins from a number of intermediate producers. The company then uses these epoxy resins as ingredients in various coatings.

Under this new agreement, Solvay, AkzoNobel and EY will develop a “chain of custody methodology” to ensure that even in situations where no physical segregation of petro and bio-based materials is practiced, volumes may still be assigned and reported.

“This is a vital next step to measure and share with partners our progress in using Solvay’s bio-based epichlorohydrin,” explained Peter Nieuwenhuizen, AkzoNobel’s Director of Innovation and Partnerships. Added Jean-Luc Préat, Head of the Epicerol business in Solvay’s Emerging Biochemicals Global Business Unit: “We welcome the expertise of EY to monitor progress in the implementation of this innovative partnership along the value chain.”

Epicerol has a substantially lower carbon footprint than fossil-produced epichlorohydrin and is already used in AkzoNobel’s coating products worldwide. By 2016, the company aims to source 20 percent of its total epichlorohydrin demand as bio-based material.

“This methodology will not just be useful for Epicerol, but can be applied more broadly in chemical value chains,” said Franc van den Berg, EY partner for Cleantech and Sustainability. “This is an important enabler for establishing a stronger position for bio-based chemicals in the chemical business.”

Jürgen Hambrecht elected as new chairman of the Supervisory Board of BASF SE

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ichael Diekmann and Robert Oswald re-elected as deputy chairmen. In its constitutive meeting, the new Supervisory Board of BASF SE has elected Dr. Jürgen Hambrecht as its new chairman. Hambrecht thus succeeds

Dr. h.c. Eggert Voscherau, who took over as chairman following the Annual Shareholders’ Meeting 2009 and who was no longer available for re-election by today’s Annual Shareholders’ Meeting. As vice chairmen, the Supervisory Board elected Michael Diekmann and Robert Oswald, both of whom had previously held this function.

The Annual Shareholders’ Meeting of BASF SE elected the following shareholder representatives as members of the Supervisory Board: • Dame Alison Carnwath DBE, London • Professor Dr. François Diederich, Zurich • Michael Diekmann, Munich • Franz Fehrenbach, Stuttgart • Dr. Jürgen Hambrecht, Neustadt/Weinstraße • Anke Schäferkordt, Cologne Besides Voscherau, Max Dietrich Kley, who has served on the Supervisory Board since 2003, also did not stand for re-election.

The BASF Europa Betriebsrat (European works council) previously appointed the following employee representatives to the Supervisory

Board of BASF SE: • Robert Oswald, Altrip • Wolfgang Daniel, Heidelberg • Ralf-Gerd Bastian, Neuhofen • Michael Vassiliadis, Hanover • Francesco Grioli, Ronneberg • Denise Schellemans, Brecht/Belgium The appointments of the Supervisory Board members are valid until the end of the Annual Shareholders’ Meeting 2019.

In its constitutive meeting, the Supervisory Board also newly appointed its committees. All shareholder representatives are members of the Nomination Committee, which is chaired by Hambrecht. The Personnel Committee comprises Diekmann, Oswald, Vassiliadis and is chaired by Hambrecht. The Audit Committee comprises Fehrenbach, Bastian, Vassiliadis and has Carnwath as its chair and financial expert.

Barentz International and Additive Solutions join forces to expand their business in Australia and New Zealand

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arentz International and Additive Solutions from Australia proudly announce their strategic cooperation for the sales, marketing and distribution of specialty ingredients across Australia and New Zealand.

Headquartered in Melbourne Australia, Additive Solutions services a range of industries including the food, beverage, confectionary, nutrition, health and well-being and animal health sectors across Australia and New Zealand. For www.fecc.org

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Members News Barentz International, headquartered in The Netherlands and active in close to 40 countries across three continents, the strategic partnership with Additive Solutions adds two strategically important country representations to the Barentz Food & Nutrition business.

Hidde van der Wal, CEO of Barentz International explains that Barentz had been searching for a strategic partner in Australia for some time to strengthen its position in this part of the world. Barentz was looking for a company that shared similar values including strong technical expertise, an emphasis on quality ingredients and customer service.

Hidde van der Wal adds: “The technical understanding of our sales force and the technical application expertise we can offer our customers throughout their product development and production stages is a very important business driver for us. We were impressed with the expertise and skills of the Additive Solutions team, and this was a very important aspect in our decision to join forces with them.”

Jim Nanos, Managing Director of Additive Solutions explains: “This development is an absolute advantage for our customers. Supported by Barentz’s industry extensive networks and deep industry knowledge we are able to offer a very comprehensive product range across both Australia and New Zealand. Vitablend’s range of antioxidant blends and nutritional premixes is an obvious example. I am also personally delighted to be representing LI Frank who produce innovative bean and grain based ingredients including Lupin proteins, which are grown in Australia.”

Barentz International has acquired a majority stake in Additive Solutions who will also be handling the sales, marketing and distribution of the LI Frank and Vitablend ingredients and products.

Ongoing positive trends for Brenntag in the major regions • Gross profit* up 4.4% on a constant currency basis to EUR 483.6 million • Operating EBITDA** up 2.8% on a constant currency basis, totalling EUR 164.0 million • Profit after tax of EUR 72.1 million and earnings per share of EUR 1.40 renntag recorded growth in gross profit compared with the first quarter of the previous year. The two largest regions - Europe and North America - performed particularly well, despite extreme weather conditions in North America.

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Profit after tax totalled EUR 72.1 million in the first quarter of 2014.

Consequently, the earnings per share attributable to Brenntag’s shareholders amounted to EUR 1.40 in the first quarter of 2014, thus exceeding the figure of EUR 1.35 for the same quarter of the previous year.

The free cash flow increased to EUR 75.7 million in the period under review after EUR 70.5 million in the same period of the previous year. Steven Holland, CEO of Brenntag AG: “While the economies in the developed regions North America and Europe are clearly recovering, the markets in the emerging regions hold challenges. This is also reflected in our results in the first quarter 2014. The strong performance of Europe and the positive trends in North America make us optimistic for the future. In addition, the somewhat weaker results in the two much smaller regions of Latin America and Asia-Pacific are likely to be merely temporary. We will keep on investing continuously in developing our business in order to strengthen and enhance our market position in all regions”.

Outstanding performance in Europe A clear change of trends in European business has been achieved, and results are improving continuously. External sales increased by 2.7% year-on-year on a constant currency basis (2.1% as reported) to EUR 1,175.6 million.

The efficiency measures and process optimizations carried out in the past are showing a very positive effect. This and the improved overall economical development in Europe are the cornerstones of this development. Year-on-year, operating gross profit* rose by 5.4% on a constant currency basis (5.0% as reported) to EUR 244.1 million. Operating EBITDA** increased significantly by 10.2% on a constant currency basis (9.9% as reported), reaching a healthy figure of EUR 83.2 million.

Brenntag optimistic regarding prospects for the rest of the year Brenntag expects to see growth in all of the relevant performance indicators for the current year. As a result of the positive trends in Europe and North America, Brenntag can be confident about the rest of the year ahead. Brenntag also considers itself to be well-positioned to benefit as the global economy slowly recovers.

Source and more information on: www.brenntag.com

Over 130 companies registered! don’t miss out & register today on: www.fecc-congress.com

Sales amounted to EUR 2,416.1 million, corresponding to growth of 2.9% on a constant currency basis (-0.1% as reported). Year-on-year, gross profit*, one of Brenntag’s key performance indicators, increased by 4.4% on a constant currency basis (1.2% as reported) to EUR 483.6 million.

Operating EBITDA** increased by 2.8% on a constant currency basis (-0.4% as reported) to EUR 164.0 million. www.fecc.org

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Members News Biesterfeld AG, Hamburg, continues its expansion path

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uring the business year 2013, the Biesterfeld Group Hamburg continued its steady growth. In a challenging market environment, the group increased its revenue by 6.1% to around € 1.057 bn, thereby clearly surpassing the 1 billion euro line.

Despite challenging market conditions, the Biesterfeld Group was successful in expanding its market shares and increasing revenue. The operative profit (EBIT), at around € 29.4m, remained just below prior year’s figure (€ 29.7m), which had been influenced by extraordinary items.

Inconsistent price and margin trends – particularly in the plastics and natural rubber industries – as well as weak international trade stimuli affected the group’s profit.

The Biesterfeld Group’s positive business development was due in large part to the two business units, Biesterfeld Plastic and Biesterfeld Spezialchemie. The acquisition of Küttner GmbH in Germany and SMPC Production S.A in France, in addition to the joint venture Biesterfeld Nordic AB, founded in 2013, and the recently established Thai company Biesterfeld International Ltd., also had a positive impact on business operations.

“In the past year, we were successful in increasing our market share in Europe, expanding into new regions, and widening our portfolio with new products and product groups. We entered 2014 with renewed strength. The remarkable first quarter results affirm our strategy,” said Birger Kuck, CEO of Biesterfeld AG. The Biesterfeld Group expects continued growth in 2014.

Biesterfeld AG is the strategic holding company of the Biesterfeld Group with its 100 year tradition in the chemicals business. The company is one of the leading enterprises in chemicals and polymer distribution with over 50 locations worldwide in Europe, the Americas, as well as in Asia. The family owned company will continue to focus on steady profitable growth within their core business divisions Plastics, Specialty Chemicals and International.

KRAHN CHEMIE enters Italy through the acquisition of Pietro Carini

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RAHN CHEMIE GmbH has acquired a majority share in Pietro Carini S.p.A., a speciality chemical distributor headquartered in Milan.

Founded in 1868, Pietro Carini is a well-established player in the Italian market in which it represents some firstclass chemical producers. Pietro Carini has 27 employees and supplies speciality chemicals to the plastics, rubber, adhesives, sealants, inks, and coatings industries. Pietro

Carini was the first Italian chemical distributor which was ESAD II certified.

With the acquisition of Pietro Carini only one year after the takeover The new Management Board of Pietro Carini S.p.A.: Axel of ICH Benelux KRAHN Sebbesse, Emanuela Bozzi and Enrico Bozzi (CEO) CHEMIE consistently follows its regional growth strategy within Europe started in 2009. Italy is the third largest chemical distribution market in Europe and still very fragmented.

“The acquisition of Pietro Carini is a high strategic fit,” Axel Sebbesse, Managing Director of KRAHN CHEMIE, comments. “Pietro Carini provides us with a strong regional footprint and with a solid basis for further growth in the highly attractive Italian market. The long-term relationships to strategic suppliers and the in-depth local industry expertise of the team of Pietro Carini will also strengthen our existing core business segments in Europe.”

Enrico Bozzi, Managing Director and co-shareholder of Pietro Carini, states, “KRAHN CHEMIE is a strong partner for Pietro Carini. We both have a very similar market approach by providing added value for our customers through technically driven sales and distribution, close and reliable co-operations and a clear long-term commitment to the market. Being part of the KRAHN CHEMIE Group will ensure stability and sustainable growth for Pietro Carini in Italy – to the benefit of our customers and supplying partners.”

EC clears proposed Solvay/INEOS joint venture

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olvay and INEOS obtained European Commission (EC) clearance for their proposed 50/50 chlorvinyls Joint Venture.

Commission clearance is subject to implementation of an agreed remedy package comprising divestment of the following INEOS owned assets: • the membrane chlorine plant and EDC/ VCM plants at Tessenderlo, Belgium • the PVC plant at Mazingarbe, France • the PVC plant at Beek, the Netherlands • the PVC and VCM plants at Wilhelmshaven, Germany • the EDC plants at Runcorn, UK. In addition, the Commission requires the membrane chlorine plant at Runcorn to be placed in a Joint Venture between the INEOS/ Solvay Joint Venture and the new owner of the aforementioned plants.

The required remedy package must be implemented before the Joint Venture can be formed. INEOS and Solvay will continue to run their businesses separately until completion of the transaction, which is expected in Q4 2014. www.fecc.org

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Members News NRC is new supplier of Akzo Nobel Chemicals AG products

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ince February 2014, Nordmann, Rassmann has been distributing products from Akzo Nobel Chemicals AG throughout Germany for the construction and paint industries.

For the construction industry, NRC offers Azko Nobel’s wide-ranging ELOTEX® portfolio of redispersible polymer powders and specialty additives. The polymers are based on various monomers like vinyl acetate and versatate, and on ethylenes and acrylates. Among others, the powders are utilized to enhance the elasticity of hardened mortars, and to increase strength and tensile bond strength. Modified BERMOCOLL® cellulose ethers improve processing characteristics and increase water retention.

In the field of paint manufacture, the company markets a variety of non-ionic cellulose ethers for water-based paints known as BERMOCOLL®. The products are available in enzyme-resistant and hydrophobically-modified varieties.

BERMOCOLL® is suitable for use in interior and exterior paints of differing levels of gloss, in addition to texture paints and dispersion plasters. New are the BERMOCOLL® Prime cellulose ethers, optimised for use in latex paints.

The products’ improved flow properties assist with pigment dispersion during the grinding process. BERMOCOLL®’s excellent water retention qualities also help keep water within paint layers, slowing both evaporation and penetration into the subsurface.

Fecc Activities Fecc Annual Congress 2014

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he Fecc Congress is the number one choice of top leaders from the chemical distribution industry for networking. This is a wonderful opportunity to generate new business and reinforce existing relationships and at the same time learning new methods to improve your company’s performance.

Over 130 companies and over 210 delegates have already confirmed their presence, don’t miss out and register today! Want to know who will be there? visit: www.fecc-congress.com/who

Join us to celebrate Fecc’s 60TH Anniversary With a Longer Opening Reception 19:00-22:00 Please join us for a full evening of networking to celebrate 60 years of working together. Attending the Opening Reception is a great start to the congress. Enjoy three hours to meet fellow delegates in a unique setting. We will celebrate this important occasion on the rooftop pool of the Radisson Blu hotel with cocktails and walking dinner.

If it is the first time you are joining the Fecc Congress for the first time, please join us for a first time delegates reception at the rooftop pool of the Radisson Blu hotel at 18:30 (Monday 26).

Register today on:

www.fecc-congress.com

Highlights of 2014 • Sales & Marketing • The Chemical Distribution Market • Software Solutions • Legislation • Future Trends • Networking opportunities • Experience & Advice on Competition Compliance • Understanding the advocacy process • The Chemical Industry by 2050 • Effect of energy prices on the EU & US economy • Shale Gas • Reputation Management • Setting the right sales targets • Trends to watch in CRM • Legal aspects to consider when using new technologies

CONGRESS MOBILE APP, WEB DELEGATES AREA & MATERIALS Fecc is virtual! All materials related to the Congress and all up to date information can be found on the Congress Mobile App and Delegates Area on the congress web. All documentation is only be available digitally.

Scan this QR code to download the congress mobile app:

www.fecc.org

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Fecc Activities

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raceability… Food Grade… HACCP… BRC…? Want to know more….

Join us in our 2014 Fecc Product Stewardship Seminar FOOD SAFETY: HOW TO COMPLY AS A CHEMICAL DISTRIBUTOR. The event will be held in Brussels on September 17th, 2014 and will be FREE CHARGE.

distributors are facing.

The aim of the seminar is to give the participants among others a good understanding of the different quality systems available and give practical case studies viewed from every angle within the supply chain.

This seminar will focus food safety Read the programme here! in the chemical supply chain with a Register today here! specific emphasis on the problems Places are limited!

Meeting Description:

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anufacturers and distributors today have a myriad of channels they use to sell their products. But how do they choose the most effective path? How can they reframe their thinking about specific channels? And can they successfully transition from one channel to another? ©Shutterstock/Maksim Kabakou

Registrations are now open!

Case Study Review: How Manufacturers & Distributors Can Optimize Their Online Channel

Cefic seminar on product environmental footprint and life cycle analysis

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ecc attended the Cefic seminar on product environmental footprint and life cycle analysis. After an introduction to life cycle thinking, case studies and good practice promoted by the World Business Council on Sustainable Development (WBCSD) were explained. The paint industry (CEPE) reported on its practical experience on how to prepare an environmental footprint evaluation under the EU umbrella. The Belgian association Essenscia went through a web tool, developed recently under SUSCHEM that allows an EX-ANTE evaluation of available methods for life cycle assessment. During the presentations and discussions it was made clear that the various available methodologies are complex and not fully comparable. In addition, the use of specific data bases clearly impacts on the result of the assessment.

Own data are often preferable, but average or sector specific data can serve as back-up - provided it is clearly explained!

In the afternoon participants debated about the role of associations, their needs and how to convince their members to embark on LCA or foot

printing. The first item highlighted was that unless the business case is visible and CEOs are convinced, companies will not be keen to go for it. It was however clearly noted that interest in and awareness of LCA has increased in recent years. National associations are willing to receive regular updated information on what is developing globally and at EU level, and are happy to convey the messages in their own country. This could improve their members’ awareness but would not reduce the cost or uncertainties linked to those - not yet harmonised approaches.

The example of Plastics Europe working with suppliers and downstream users was a good demonstration that costs can be minimised when working together, and that networking and advocacy to the outside world can be facilitated. Costs can also be reduced by focusing on a key parameter (carbon foot printing) or product (innovative ones). Social and economic assessments linked to LCA were also debated as developing areas that need to be further developed and standardised in the future. The presentations are available on the Fecc website (members’ area).

There are many barriers to doing traditional e-commerce, and in many cases a traditional approach may not be optimal.

In this 60-minute webcast, Brian Strojny, co-founder of Insite Software, and Scott Powell, VP II, CMS and Ecommerce, NTT Data, outline how several organizations created three-year digital plans that laid out alternative ways to sell their products and reach their target customers.

Strojny and Powell will discuss: • The barriers many manufacturers and distributors face when considering e-commerce • How a digital roadmap will help distributors and manufacturers explore alternative methods of selling online • How to manage the disruption of new competitors and new channels facing businesses.

More information on: cc.readytalk.com www.fecc.org

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EU Chemicals Legislation First substance evaluation decisions published: Registrants are requested to submit further information on hazards and/or exposure

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irst ECHA decisions on substance evaluation are now available on ECHA’s website. These are the decisions on 14 substances taken by ECHA based on evaluations carried out by Member States. A decision on substance evaluation means that there is a need for further information to conclude on the concern on a substance. From the substances listed in the CoRAP for 2012 there were 32 substances for which the evaluating Member States originally proposed a draft decision. After the Member States’ review and discussions and unanimous agreement in the Member State Committee ECHA has taken final decisions on 14 substances.

Each decision defines a deadline by which the registrants subject to the decision must deliver the requested data in a IUCLID dossier update to ECHA. The evaluating Member State will then review the data and conclude on the risks and follow up actions, if deemed necessary.

In future, ECHA will continue publishing the decisions in batches without separate communications upon publication of each batch.

Substance

EC-number

Evaluating Member State

Isoheptane

250-610-8

Latvia

Bisphenol A, 4,4'-isopropylidenediphenol

201-245-8

Germany

Imidazole

206-019-2

United Kingdom

A mixture of: cistetrahydro-2-isobutyl-4-methylpyran-4- 405-040-6 ol; transtetrahydro-2-isobutyl-4-methylpyran-4-ol

Spain

Oligomerisation and alkylation reaction products of 700-960-7 2-phenylpropene and phenol

Denmark

N,N'-bis(1,4-dimethylpentyl)-p-phenylenediamine

221-375-9

Belgium

Carbon tetrachloride

200-262-8

France

1,3-Diphenylguanidine

203-002-1

France

Hexyl salicylate

228-408-6

The Netherlands

2,2'-Iminodiethanol

203-868-0

Germany

2-Ethylhexanoic acid

205-743-6

Spain

Decahydronaphthalene

202-046-9

Finland

Alkanes, C14-17, chloro (MCCP, Medium chained 287-477-0 chlorinated paraffins)

United Kingdom

2-(4-tertbutylbenzyl)propionaldehyde

Sweden

201-289-8

Please find more information on: Comunity rolling action plan table with decisions documents www.fecc.org

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EU Chemicals Legislation Launch of the ECHA Subst ID screening campaign

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CHA has been announcing to look at substance identity more in depth in 2014, which will result in an important number of letters that will be send.

According to ECHA, unambiguous substance identification is a prerequisite to most of the REACH processes. Indeed actors in the supply chain must have sufficient information on the identity of their substance. The correct identification of a substance will enable, for example: • The sharing of information by potential registrants and data holders to prevent the duplication of testing on animals and unnecessary costs • The assessment of the applicability of test data across companies who registered the same substance, the assessment of read-across proposals (categorisation approach) or the use of non-test information • The assessment if a substance is included in the Authorisation List, the list of restrictions or if its classification and labelling has been harmonised

Following the automatic screening of its database, ECHA intends to send out informative letters to companies in which (potential) substance identity incompliances in their dossiers are pointed out. So far ECHA has identified frequent shortcoming in dossier evaluation with about 66% of decisions in 2012. Companies are expected to spontaneously update their dossier in following the instructions given in the letters.

• Clear and concise description of the analytical methods

Critical points of concern for ECHA, regarding SID, are for instance: same analytical information present in more than one registration dossier (which means that analytical data attached in one dossier have been shared with other registrants), missing concentration ranges, inconsistent concentration ranges and purity, deviation from 80%-rule, inconsistency The SID screening campaign will start with identifiers. in Q1 2014 with a first batch of letters sent, a subsequent one will be sent ECHA informed that some 1400 letters on substance identity were sent early later over the year.

The following information on the April. Three months were given to manufactured or imported substance update. Please do check your REACH-IT shall be included in the dossier in mail boxes. A webinar will be organized order to unambiguously identify the on 30 April. The invitation to the webinar was sent in the coming days substance: • Substance name and related to the companies that have received a identifiers, molecular and structural letter. formulae, if applicable • Information on the composition and Please also note that the technical Annex has been updated and is purity of the substance • Spectral data and analytical available in the SID screening section: information to verify the identity echa.europa.eu and composition of the substance

New version of REACH-IT clarifies communication between ECHA and companies

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he new version of REACH-IT (2.7), now ready for use, introduces new terms and conditions that clarify how companies receive decisions and other communications from ECHA. In addition, the update now allows the submission of applications for authorisation through REACH-IT. At the same time, a new version of IUCLID launched.

Together with REACH-IT, a new version of IUCLID is published.

The update (version 5.6) adapts IUCLID to the fourth revision of the CLP Regulation and allows registrants and notifiers to comply with this regulatory update. More information about the release of IUCLID 5.6 isavailable on the IUCLID website.

ECHA will still continue to accept IUCLID dossiers made with the previous IUCLID versions 5.4 and 5.5.

Ninth Stakeholders’ Day - 21 May 2014, Helsinki

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CHA is organizing its 9th Stakeholders meeting on the 21 May in Helsinki. The conference programme includes external speakers from Bayer AG, the European Environmental Bureau and the Aerospace and Defence Industries Association of Europe.

Marianne Lyngsaae from Brenntag Nordic and active member of the SHE Committee will also present a case study on downstream users and REACH. Participants will also be able to hear a case study from a small company about their experiences with REACH registration.

For more information on the event please visit: echa.europa.eu For more information on EU Chemicals Legislation contact: Ophélie Roblot +32 (0)2 679 02 60 oro@fecc.org www.fecc.org

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EU Chemicals Legislation The Biocidal Products Committee adopts its first opinions he Biocidal Products Committee (BPC) met from 8 to 10 April 2014.

The first three opinions adopted were in relation to industry applications to approve active substances for use in biocidal products:

Permethrin for PT 8 and 18 Permethrin is an active substance evaluated in product-type (PT) 8, wood preservatives and PT 18, insecticides, acaracides and products to control other arthropods. As a wood preservative, permethrin is intended to be applied to preserve wood for preventive and curative treatment of for example fences, roadside noise barriers and electricity transmission posts. Permethrin is also used as an insecticide, for indoor use by spot treatment in cracks and crevices by professionals or non-professionals and for the treatment of textile fibres to be used for example in the manufacture of carpets.

a polymeric binder material on the market for use in paints to confer anti-microbial properties to painted surfaces. In relation to this the European Commission has requested the Agency for an opinion on whether the polymeric material contributes to the biocidal properties of paints, contains a biocidal active substance and if so, what is the identity of that active substance?

The BPC concluded in its opinion that the polymeric material contributes to the biocidal properties of antimicrobial paints, the polymeric binder is a biocidal active substance and has clarified its identity.

ŠShutterstock/molekuul.be

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as tralopyril, companies have to apply for approval of an active substance by submitting a dossier.

After a validation check the evaluating competent authority carries out an evaluation within one year. The result of the evaluation is forwarded to the BPC, which prepares an opinion within 270 days. The opinion serves as a basis for the decision-making by the European Commission and the Member States.

The approval of an active substance is granted for a defined number of years, not exceeding ten years.

The Commission also asked the BPC for an opinion on whether silver absorbed on silicon dioxide intended to be used in the treatment of textiles is a nano material, what constitutes the active The evaluating competent authority substance and how to specify it. The of the active substance application is BPC adopted its opinion and clarified Ireland. that it is a nanomaterial according to the definition in the BPR but that it is premature to draw up further detailed Tralopyril for PT 21 Substances which were on the market specifications.

Tralopyril is a new active substance before 14 May 2000 and are evaluated evaluated in PT 21, antifouling products. under the review programme in an Products containing tralopyril are Background Information analogous manner to new active intended for professional use on ships substances are referred to as existing to control a range of animal and algal The Biocidal Products Committee active substances. Permethrin for prepares the opinions of ECHA related product types 8 and 18 are review fouling organisms. to several processes under the Biocidal programme substances.

The evaluating competent authority of Products Regulation. Each EU Member the active substance application is the State is entitled to appoint one Article 75(1)(g) of the BPR states that member to the BPC for a renewable the BPC is responsible for preparing an United Kingdom. term of three years. opinion on any other questions that may arise from the operation of the Specific requests from the BPR relating to technical guidance or Commission In relation to applications for the risks to human health, animal health A company has proposed to place approval of new active substances such or the environment.

Over 130 companies registered! don’t miss out & register today on: www.fecc-congress.com www.fecc.org

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GTDP European Medicines Agency (EMA) presents report to the Commission on pharmacovigilance

The report, which covers the period 2 July 2012 to 1 July 2013, reveals positive results for ensuring the main objectives of the new legislation, i.e. better collection of key information on medicines, improved analysis and understanding of data and information, improved timeliness of procedures, greater transparency, etc.

• P r o d u c t information changes for medicines following assessment of signals of new or changing safety issues. For example, hearing disorders associated with medicines containing roxithromycin and the risk of hypoglycaemia associated with medicines containing tramadol.

• Training thousands of individuals in pharmacovigilance, and publication of a catalogue with training material for the implementation of the new legislation.

• Initiation of a number of major public health reviews. For example on: • all combined hormonal contraceptives and venous thrombo-embolism, • Diane-35 and generics (medicines containing cyproterone acetate/ ethinylestradiol) and venous thrombo-embolism, • Codeine-containing medicines used for pain relief and overdose in children.

Some of the concrete achievements during the first-year reporting period are: • Nearly 25 000 patient reports of suspected adverse drug reactions - an increase of more than 60% compared to the previous 12 months.

Full report is available here - ec.europa.eu

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he European Commission’s Scientific Committee on Consumer Safety (SCCS) has published its opinion on the safety of aluminium in cosmetics, as well as on six other substances.

The Committee comes to no conclusions regarding safe concentration limits for aluminium, due to a lack of data on dermal penetration to estimate the internal dose of the substance following cosmetic use.

Going forward, the SCCS suggests that a human exposure study under real-life conditions is conducted. ©Shutterstock/Picsfive

he European Medicines Agency (EMA) has presented the European Commission with its first report on the tasks it undertook during the first year of application of the EU’s new pharmacovigilance legislation.

Responsibility for implementing the new legislation is shared between the European Commission, the national competent authorities and EMA.

©Shutterstock/Jane0606

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EU Scientific Committee issues opinion on aluminium in cosmetics

There is, however, no evidence that aluminium in the levels reached with cosmetic use is carcinogenic, increases the risk of breast cancer, Alzheimer’s disease, or chronic neurodegenerative diseases, the SCCS concludes.

Source: ChemicalWatch: chemicalwatch.com

In-vitro market strongest in Europe as testing alternatives take centre stage

Record breaking amount of fake cosmetics seized in Dubai, despite rise in consumer trust

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new market report by Markets and Markets details the size and growth of in-vitro toxicology and toxicity testing markets across the world states that Europe is to hold its position as largest until 2018.

he Department of Economic Development in Dubai has seized a staggering 1.4 million counterfeit cosmetics from just one warehouse, with an estimated market value of Dhs16m.

Source: Cosmeticsdesign-europe: www.cosmeticsdesign-europe.com

Source: Cosmeticsdesign-europe www.cosmeticsdesign-europe.com

For more information on GTDP contact: Joel D’Silva +32 (0)2 679 02 62 jds@fecc.org www.fecc.org

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GTDP Croda Europe site receives EXCiPACTTM Revised EU Good certification as pharmaceutical excipient m a n u f a c t u r i n g supplier practice (GMP) roda Europe Ltd of pharmaceutical excipients Guidelines chapter C Goole, UK, has received according to the EXCiPACT™ an EXCiPACT™ Certificate Good Manufacturing 6 “Quality Control” from SGS ICS France, one of Practice (GMP) and Good EXCIPACT’s internationallyDistribution Practice (GDP) published recognised Bodies.

Certification

The Certificate demonstrates that the Croda sites at Rawcliffe Bridge and Thorne near Goole, UK manufactures and distributes

Certification Standards.

This is the first UK site to receive Certification and the 10th globally to date.

For more information visit: www.excipact.org

European Commission releases Good Distribution Practice : A “Question and Answer” document for medicinal products

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ffective October 1st, 2014 the revised EU GMP chapter 6 “Quality Control” was published on March 28th 2014. As reasons for the changes the inclusion of a new section on technical transfer of testing methods and other items such as Out Of Specification (OOS) results are listed. Both items are consequently covered in more detail in the new chapter with the items 6.37 – 6.41 (technical transfer) and 6.7, 6.9 & 6.35 (OOS), respectively.

For a technical transfer of testing methods a detailed protocol shall be prepared. Furthermore it shall be verified that the test method(s) comply with those as described in the Marketing Authorisation (MA) or the relevant technical dossier. The technical transfer shall be closed with a technical transfer report including code relating to medicinal products for potential deviations from the protocol human use (Directive 2001/83/EC). and related investigations. ©Shutterstock/Zyxx

he wholesale distribution of medicinal products is an important activity in the integrated supply chain management.

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The quality and the integrity of medicinal products can be affected by a lack of adequate control. To this end, the Commission has published guidelines on Good Distribution Practice of medicinal products for human use in the form of a Commission The “Question and Answer” document guideline 2013/C 343/01. responds to frequently asked questions The present guidelines are based on in relation to the guidelines on Good Articles 84 and 85b(3) of Directive Distribution Practice of medicinal 2001/83/EC of the European products for human use.”

Parliament and of the Council of 6 November 2001 on the Community Link: ec.europa.eu

Concerning OOS and Out Of Trends (OOT) results a written procedure has to be in place and such results need to be investigated. This is required for any analytical tests results, yields, environmental controls etc.

Link: ec.europa.eu

Rx-360 releases White Paper on EXCiPACTTM signs Upstream Supply Chain Security agreement with AJA he white paper primary direct contact materials (bags, Registrars Germany

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addresses pharmaceutical raw materials, A c t i v e Pharmaceutical Ingredients (APIs), excipients, starting materials for APIs and excipients, process materials,

filters, tubing), and primary packaging EXCiPACTTM materials.

This paper also discusses parties involved in the chain of custody or GxP services (i.e., sterilizers, contract lab services, warehouses, and logistics (including 3rd-party providers)).

L ink: rx-360.org

has completed an Agreement with AJA Registrars Germany GmbH, an internationally-recognised Certification Body, for the certification of the manufacture and distribution of pharmaceutical excipients according to EXCiPACT’s Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) Certification Standards. www.fecc.org

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International Trade EU and Japan exchange offers to open markets Officials from the EU and progress achieved during Japan exchanged offers to the first year of talks and open their markets to each assess implementation of other’s products. The fifth commitments made by round of negotiations for Japan prior to the launch a free trade agreement of the negotiations. The between these two agreement could boost economic powerhouses Europe’s economy by 0.6% also made headway towards to 0.8%. Once the agreement consolidating the chapters of the future is in place, EU exports to Japan could agreement and putting on paper some increase by over 30%, while Japanese new joint provisions. exports to the EU would increase by over 20%.

As specified in the EU’s negotiating mandate, the EU will now review Source: DG Trade - trade.ec.europa.eu

EU & Other News Business services crucial for keeping EU/Access to Europe’s industry fit finance: EIB’s new importance of Business Services and legal services, design, engineering program confirming Ttheheshould be adequately reflected in and technical maintenance services, Europe 2020 Strategy according recruitment, security and industrial its strong support to to a report of the High Level Group on cleaning. Business services are an Business Services. integrated part of our industrial value SME European Commission Vice President Antonio Tajani responsible for Enterprise and Industry policy said: “Business services in Europe have a significant untapped growth potential, especially in terms of productivity and innovation uptake. The Group’s Report has put the spotlight on the important role that business services play for the European economy. It demonstrates that high performing business services are crucial for our economic value chains and hence European competitiveness. Business services will be essential for achieving an industrial renaissance.”

chains and essential for European competitiveness, a strong Single Market and an industrial renaissance.

The High level Group chaired by Professor Carlo Secchi of the Bocconi University was set up in order to study the shortcomings existing in this sector and help policy makers better understand the current challenges.

The Group recommends actions along several lines. In addition to prioritising business services in the Europe 2020 strategy, these include the completion of the Single Market for services, seizing the international opportunities and developing the right skills and technological infrastructure needed by European companies.

The recommendations are issued to the Commission, but also to Member States and industry (for the full recommendations, please see MEMO/14/265).

The group was launched by VicePresident Tajani and Commissioner Barnier in March 2013 to help define a European policy agenda for this important sector. Business services are services provided by businesses to other businesses. Typical examples include: management consultancies Source & info: ec.europa.eu

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n 31 March, the European Bank of Investment renewed its commitment to SME. A new program worth EUR 2 billion for the second quarter of 2014 will focus on speeding up lending operations.

Based on the complementary nature of the EIB loan for SMEs, the proposed EU Loan is expected to generate up to EUR 4bn of financing.

The program aims at stimulating SMEs’ capacity of investment, which is being seriously hampered in current market’s conditions. The EIB is sending a strong signal, placing SME support at the core of its contribution policy.

To read about EIB’s program, please visit: www.eib.org www.fecc.org

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EU & Other News EU adopts stronger rules to better defend its rights under trade agreements

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he European Commission welcomes a new legal framework approved by the European Parliament on April and by the EU Council to better enforce EU rights under international trade agreements.

The new rules will allow for a more effective EU response to illegal measures taken by our trading partners. The new regulation gives the EU a single horizontal framework to react swiftly and effectively to make sure that trade agreements translate into real benefits for EU businesses and workers.

“These new enforcement rules will help us ensure that trade agreements are respected and deliver benefits for the EU economy. The EU is now better equipped to take action when other countries don’t play by the rules,” said EU Trade Commissioner Karel

Recourse to lengthy legislative procedures, which are ill-suited for the swift adoption of effective enforcement measures, will no longer be necessary.

The Commission can now increase customs duties, set an import quota or impose limitations on access to public contracts in the EU by means of an executive decision to prompt the offending country to remove their illegal measures. ©Shutterstock/Sampien

The Commission will now also have legal powers to compensate for import restrictions imposed on EU products in exceptional situations (socalled safeguard measures), or to react to cases where a WTO member raises its import tariffs without adequate compensation for the EU.

De Gucht. If an international trade panel – a WTO panel or a dispute settlement panel created under a free trade agreement – finds an EU partner country does not abide by international trade rules, the Commission will now be able to adopttrade sanctions under Source & Info: ec.europa.eu a streamlined procedure.

Regulated professions: European Commission publishes European map of regulated professions

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he European Commission has today published a European map of regulated professions those professions to which access is conditional upon the possession of specific qualifications or for which the use of a specific title is protected, e.g. pharmacists or architects. This is an essential part of the transparency process launched by the modernisation of the Directive on the recognition of professional qualifications in November 2013 (MEMO/13/867) and announced in the Communicationof 2 October 2013 on the evaluation of national regulations on access to professions (see IP/13/897).

This interactive map gathers together the most

important information on how professions are regulated in the different Member States, such as the number of regulated professions and their breakdown by sector of the economy, the trend in the number of recognition decisions since 2005, and details of the national contact points responsible for informing professionals about the procedures and formalities to be completed in order to obtain recognition of professional qualifications. The map is a graphic depiction of the information which has just been updated by the Member States in the database of regulated professions in Europe.

Michel Barnier explained that “the European map of regulated professions is a transparency tool which provides an overview of the situation on regulated professions in the Member States and the Union as a whole.

A careful examination of the map reveals the diversity of approaches adopted by Member States to protect their public interests by regulating certain professions. These approaches reflect different realities, sensitivities and regulatory backgrounds, but they are also the cause of obstacles to the free movement of qualified professionals. The added value of this map is that it provides us with a visual representation of these obstacles and allows us to direct our efforts towards the sectors and professions where the modernisation of the legislative environment is likely to have the Internal Market greatest effect.” and Services C o m m i s s i o n e r Source & Informarion: europa.eu www.fecc.org

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Fecc Meetings Calendar 2014 Date

Meeting

Location

23

Workgroup Fecc EU Responsible Care Programme

Brussels

15

International Trade Committee Focus ASEAN

Brussels

25

Board Meeting

Rome

26-28

Fecc Annual Congress “Going for growth�

Rome

10-11

Excipact Trainings

Brussels

17

GTDP Committee

Brussels

25

Responsible Care Committee

Brussels

3

SHE Committee

Brussels

17

Food Safety: How to Comply as a Chemical Distributor Workshop

Brussels

18

Product Stewardship Committee

Brussel

19

Board Meeting

Hamburg, Germany

25

GTDP Committee

Krefeld, Germany

1

Responsible Care Committee

Brussels

23

SHE Committee

Brussels

12

Fecc Membership & Board Meeting

Brussels

13

International Trade Committee

Brussels

18-19

Excipact Trainings

Brussels

Responsible Care Committee

Brussels

April May

June

July September

October

November

December 9

www.fecc.org

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Owner and Publisher: The European Association of Chemical Distributors (Fecc) Rue du Luxembourg 16B, B-1000 Brussels, Belgium www.fecc.org Chief editor: Camila Diaz, +32 26790263,cdi@fecc.org Editorial staff: Fecc Policy Managers Pictures: Shutterstock, PSD Graphics, member companies and private pictures Disclaimer The information contained in this newsletter is for general information purposes only. Through this newsletter you are able to link to external websites which are not affiliated with or under the control of Fecc. We have no control over the nature, content and availability of those sites.

The inclusion of any links does not necessarily imply a recommendation or endorse the views expressed within them.

Contact us!

Fecc secretariat +32(0) 2 679 02 60

• Uta Jensen-Korte, Director General ujk@fecc.org • Camila Diaz, Communications Manager cdi@fecc.org • Jan Thienpont, Responsible Care & Logistics Manager jth@fecc.org • Joel D’Silva, Life Science & International Trade Manager jds@fecc.org • Ophélie Roblot, Health Safety & Environment Manager oro@fecc.org • Catherine Lefranc, Assistant assistantfecc@fecc.org www.fecc.org

15

Rue du Luxembourg 16B 1000 Brussels Belgium +32 (0)2 679 02 60

www.fecc.org www.fecc.org

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