Newsletter December 2015

Issue 8– December 2015

Fecc is proud to present its new 2016 Business Plan, Informational Leaflet and we also invite you all to visit our NEW website !

New Website

2016 Business Plan

New Leaflet

Inside this issue Season’s Greetings Fecc Activities Members’ News EU Chemicals Legislation Responsible Care and Logistics International Trade &GTDP EU&Other News—Events Upcoming Events Calendar

2 3-4 5-10 11-14 14 15-16 17-18 18

1

Season's Greetings

Dear Members, We wish you all a Happy Holiday Season !

Our sincere thanks for your contribution and support throughout the past year. We look forward to working with in 2016.

Fecc Team Alexandra, Gerhard, Irantzu, Joel , Marie-HÊlène and Uta

Message from the President I would just like to thank you all for your support over the past year, your membership and participation with Fecc are hugely valued. Of course, this year we faced the evil of terrorism in Fecc's home city of Brussels, and I can only apologise that we felt the best course of action was to cancel the Membership Meeting: safety was our prime concern.

I thank you for your understanding, but I am sure that we will be able to look forward to a fantastic event next year at the Fecc Congress, when we can meet and celebrate our great industry in Istanbul. It only remains for me to thank all the Fecc staff for their hard work in 2015, and to wish all of you a wonderful Christmas holiday and hope that 2016 brings peace, health and prosperity.

Neville Prior President, Fecc 2

Fecc Activities

Fecc is proud to present its new 2016 Business Plan, Informational Leaflet and we also invite you all to visit our NEW website !

Fecc announces the launch of its redesigned website

GROWING STRONGER TOGETHER

Brussels, December 2015 - Fecc announced the launch of its redesigned website, www.fecc.org.

The new website is more user-friendly and intuitive, with improved navigation and new functionalities.

Moreover, consulting the new website on the go is smooth since it is fully responsive to mobile and tablet.

Brussels, November 2015 - The European Association of Chemical Distributors (Fecc), has published its Business Plan for 2016. The document published includes the Working Committees’ achievements for 2015 and work plan for the coming year. The business plan describes Fecc’s priorities and how the association will contribute to grow a stronger chemical distribution industry.

As an association in existence for over 60 years, we believe it is important to regularly refresh our look and ensure easy access to information about our industry.

The new Fecc website is more attractive and conveniently designed, reflecting the modern and innovative character of the European Chemical Distribution industry.”

The 2016 Business Plan is a statement of commitment to continue to support our members with high quality services through our expert committees. It is intended to help our many stakeholders understand the global marketplace and the regulatory framework surrounding it. The report also gives an update of the recent significant work efforts and accomplishments made by Fecc, in particular that of the expert working committees.

To learn more about the Fecc’s activities, achievements and plans for 2016, read and download the Business Plan on: www.fecc.org/fecc/publications

FECC INFORMATION LEAFLET The Fecc information leaflet provides an overview of our association's objectives, vision and membership benefits. It also summarises the work and activities of our working committees. You can also download it on our website : http:// www.fecc.org/fecc/publications/leaflet

As an umbrella association Fecc unites the chemical distribution sectors and provides expertise on a variety of policy issues. The new platform fully emphasises the many facets of the association’s work. Latest News and publications are grouped under the section “What’s New” and events are listed in the tab Events, but all can also be found according to Topic. This structure enables visitors to locate relevant content quickly or simply browse through recent updates.

For instance, a visitor looking for information related to Guidance documents can visit the publication page.

Narrowing down to the desired content could not be easier.

The new website also includes a members area intended to facilitate tailored communication between the association and its members and where you can also find different kinds of Fecc publications, such as the monthly newsletter and other internal documents. Go to : www. fecc.org

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Fecc Activities

2016 Sponsorship Package Booklet !

BECOME A SPONSPOR TODAY The NEW sponsorship package booklet is available now. Click here to view details. This year, you will find many useful branded goodies at the end of the booklet and these are new options which will give you great visibility as well. We thank you in advance for your continual support in making our Congress another very successful event !

Should you be interested in sponsoring or need further information about our new package, please do not hesitate to contact : Alexandra Mengesha, Communications and Membership Development Management at ame@fecc.org

Fecc invites you to register for the Good Trade and Distribution Practices (GTDP) Seminar on 27 January, 2016.

Please see attached the provisional programme and registration form. If you are interested in attending, please send the form back to us at the earliest, places are limited to 40.

Registration Fees (VAT not included 21%)

Fecc GTDP Seminar – 27 January 2016

250€ Fecc National Association Members

Regulatory and quality developments in the Pharma supply chain

300€ Non Fecc Members

Sessions

200€ Fecc Members

(Fees are inclusive of refreshments, lunch, documentation and participation certificate)

EU Good Manufacturing Practice (GMP) Chapter 5: Production

Registration deadline: 15 January, 2016

•

Impact of new regulatory changes on the supply of starting materials to the pharma industry

Sheraton Brussels Airport Hotel



Third Party auditing and compliance with new EU GMP: Chapter 5 requirements

•

Reduced testing and Quality agreement aspects

Meeting location

Brussels National Airport Brussels, 1930 - Belgium Phone: +32 2 710 80 00 Fax: +32 2 710 80 80

EU Good Distribution Practices (GDP) Guidelines for Active Pharmaceutical Ingredient’s (API’s) 

Content and implications on distributors of API’s

•

Expectations of the Pharma industry from Distributors

EU Guidelines Risk assessment for Excipient GMP 

Risk assessment for Excipient GMP – Essentials.

•

How to apply the Excipient Risk assessment for Excipient GMP: Industry perspective.

How to get there: www.starwoodhotels.com Accommodation (if required): Fecc has negotiated a group rate for you at the Sheraton Brussels Airport Hotel. The price per room is 179€ and it includes breakfast.

• Please go to: https://www.starwoodmeeting.com/ Book/FECC to book your room.

Please book your accommodation as soon as possible and no later than 26 December 2015. After this date rooms will be subject to availability.

4

Members’ news

BASF receives German Sustainability Award for resource efficiency BASF was presented with the Special Award “Resource Efficiency” at the ceremony for the German Sustainability Award 2015 on November 27, 2015. With this decision, the jury recognized BASF’s Verbund concept that has set the benchmark in the chemical industry for resource and energy efficiency for decades. In addition to the recognition for efficient raw material and energy use, the development of innovative business models for sustainability, for example, the “mass balance” method, was acknowledged by the jury. This method uses renewable raw materials from the very beginning of the value chain in the existing Production Verbund. Savings of fossil resources are calculated for each product.

BASF was also nominated in the category “Most Sustainable Large Companies” and was among the three leading companies. The German Sustainability Award recognizes companies which make significant contributions to sustainable development on a national and international basis.

Additional information on sustainability at BASF is available at www.basf.com/sustainability.

BASF announces winners of the open innovation contest on energy storage  

Four research groups each receive prize money of €100,000 for innovative battery concepts Competition is an important part of the cocreation program in BASF’s anniversary year

The winners of the BASF Energy Contest were announced at the “Creator SpaceTM Summit” in Ludwigshafen. From 122 applications submitted on the online platform NineSights, a jury of BASF experts and external specialists chose the four best proposals which will be funded with €100.000 each.

The winning concepts were nominated by the professors Patrik Johansson, Department of Applied Physics at the Chalmers University of Technology, Sweden, Paul K. Wright and James W. Evans, University of California, Berkeley, Mike Stuart Licht, Department of Chemistry at George Washington University und Xiangwu Zhang, Department of Textile Engineering at North Carolina State University.

The Open Innovation Contest, initiated by BASF at the beginning of February, aims to find ideas for the storage of energy from renewable energy sources. Sustainable technologies should make it possible to store power from the grid and feed power back into it. Together with scientists, inventors and companies, BASF is looking for efficient solutions for the long-term storage of electricity, which are financially viable, for example through lower investment costs. Innovative chemistry was to play a central role in the submitted proposals. Source and information

Well-established, Hamburgbased company TER GROUP founds specialized subsidiary TER Ingredients 

Strong growth in turnover of ingredients for Food & Feed



Setting the course for sustainable growth in the Food & Feed business

The Hamburg-based TER GROUP is set to spin off its business with ingredients for food and animal feed to a special subsidiary. From 1 January 2016, the newly founded TER Ingredients GmbH & Co. KG will take over the existing Food & Feed business from the TER HELL & Co. GmbH trading company. With this reorganization, the TER GROUP is responding to the above-average growth in the Food & Feed business unit. The turnover in 2014 amounted to €65 million.

In recent times, the business with ingredients for food and feed has become even more important at the wellestablished, Hamburg-based trading company. Founding a new company will set the course for future growth and drive the expansion of this business unit. “By founding our own new company to focus on ingredients, we will meet the 5

Members’ news demands of our suppliers more closely and establish even greater independence for this business unit regarding future decisions”, says Oliver Zimmermann, CEO of TER Chemicals Distribution Group and Managing Director of the new company TER Ingredients.

The second Managing Director at TER Ingredients will be Benjamin Lindenau, who previously worked as Business Unit Manager for Food & Feed. “We have ambitious growth plans for the future and we hope to achieve a faster and to a greater extent far-reaching implementation of these plans with our new company”, says Lindenau. In addition, customer service will be further improved by specialized and optimized processes, organization structures and quality assurance.

TER Ingredients will be run as a new company in the TER Chemicals Distribution Group. All the staff from the business unit will move to the new Hamburg-based company, which will be a 100%-owned subsidiary of TER HELL & Co. GmbH from 1 January 2016.

Source and information

LANXESS and TER GROUP signed contract concerning the distribution of industrial biocides for the markets Germany and Benelux TER Chemicals Distribution Group announces the close cooperation with LANXESS Deutschland GmbH. Purpose is the expansion and improvement of services on biocides to various industries in Germany and Benelux. With this step TER GROUP will strengthen and expand their product portfolio with synergies in all TER Chemicals Industry Management Groups.

"Right from the first contact with Ter Hell, we have been impressed with the know how about industrial applications of biocides we found at Ter Hell. We look forward to building on this expertise and broaden both our customer base and application areas by the new partnership", mentioned Daniel Schlawe, Head of Sales EMEA at LANXESS' business unit Material Protection Products.

"Lanxess biocides are an excellent supplement to our chemical specialties product portfolio and a valuable enlargement of our long term relationships with leading global chemical suppliers. The new contract provides a platform for further growth in coatings, plastics and industrial performance”, commented Wolfgang Weger, Director Business Development & Marketing TER Group.

Source and information

Recipes for Success from Univar Food Ingredients and Key Supply Partners at Fi Europe 2015

At Fi Europe 2015, Univar Food Ingredients is (offered) enticing food and drink samples containing innovative and inspiring ingredients to show how they can help food developers and manufacturers to respond to the latest consumer taste trends.

With a broad portfolio of specialty products from the world’s leading producers, Univar provides highquality ingredients to satisfy what it regards as six of the most prevalent trends in the food market today: sugar reduction, sodium reduction, gluten-free, clean label, protein enrichment, and lactose reduction. Through cooperation with key supply partners Ingredion, Fonterra, and Novozymes, Univar is demonstrating its offering of specialty ingredients that answer the call from consumers for more health-aware products and information transparency, with samples of baked goods and drinks. Two gluten-free baked goods are being cooked up: a high quality chocolate muffin using PRECISA® Bake GF texturising system and HOMECRAFT® pulse for an added protein content; and a lemon cake, also containing PRECISA® Bake GF. ( see next page)

6

Members’ news A high-fibre banana and pecan cake featuring HI-MAIZE® starch was also be served at the show. These recipes are excellent examples of Culinology®, the synthesis of culinary arts and food technology. Culinology® translates the latest food trends into workable, appealing recipes for large-scale formulations, and is now available to all of Univar Food Ingredients’ customers.

This press release and relevant photography can be downloaded from www.PressReleaseFinder.com

Univar Extends Distribution Agreement for Dow Personal Care Ingredients Univar, a global chemical distributor and provider of valueadded services, announced today it has expanded its longstanding European distribution agreement for The Dow Chemical Company’s (NYSE: DOW) Amerchol personal care ingredients to include France. Univar France is now marketing and selling the full range of Dow’s legacy Amerchol personal care specialty ingredients in the country, including: • UCARE™, SOFTCAT™ and EcoSmooth™ Conditioning Polymers •

UCON™ Fluids

•

POLYOX™ Sensory Enhancers

•

CELLOSIZE™ Thickeners

•

METHOCEL™ Functional Polymers

•

WALOCEL™ CRT Thickeners

•

ETHOCEL™ Oil Thickeners and Film Formers

•

SOLTERRA™ SPF Boosters

“The personal care market is one of Univar’s strategic global markets, and the expansion of our partnership with Dow Personal Care Solutions is an important development for our customers in France,” says Matthew Ottaway, Personal Care Industry Director, Univar EMEA. .

“Dow’s innovative personal care ingredients are a strong complement to our existing portfolio of basic chemicals and speciality products They will help us extend our total-solution approach for the technologies and services that our customers in France need to meet changing consumer demands.”

“We have a long-standing and successful relationship with Univar in many different countries. We value their commitment to our business as well as their sales and marketing expertise as we look to simplify our channel to market strategy in France,” says Philippe Nastasi, EMEAI Sales director for Dow Home, Institutional and Personal Care Solutions.

“The technical knowledge of Univar’s support team and on-the-ground presence provides a real benefit when it comes to promoting these specialties.”

Univar has distributed Dow’s Personal Care ingredients across Europe for more than 10 years, continually expanding the range of products and territories covered.

Building on a global network of laboratories, technical expertise, and shared best practices, Univar provides its customers with an extensive range of solutions that help them address consumers’ needs and inspire new product development.

To learn more about Univar’s comprehensive range of personal care ingredients, Univar’s dedicated personal care specialists will be on hand at Cosmetagora at stand 48-50 in Paris, France, from 12-13 January, 2016, and at In Cosmetics (stand H90) in Paris from 12-14 April, 2016.

This press release can be downloaded from www.PressReleaseFinder.com.

Biesterfeld AG publishes its first sustainability report Biesterfeld AG, Hamburg, is releasing its first sustainability report. The report provides an overview of the current activities of the group in economic, environmental and social spheres. As a chemicals and plastics distributor, Biesterfeld places a high value on the safe and environmentally friendly use of its products as well as energy, water and other raw materials.

7

Members’ news

"For Biesterfeld, sustainability is more than just a word in the company brochure. For us, it means acting sustainably, behaving responsibly and focusing on the long-term consequences", says Thomas Arnold, CEO. "The report details, in black and white, the measures currently being implemented and the targets already met." One important goal of the measures enacted and those being planned for the responsible management of resources and people is the reduction of energy consumption. In coming years, resource usage and additional improvement activities will be the focus for sustainability.

sells its products to clients without any further uses in processing (ie : most of distributors, as they resell same products). This Convention applies when one of the two contracting parties is french ; this means that international and European companies are also affected when dealing with a French company ; both are responsible in legal terms for non compliance ; Convention must be signed each year before the end of March.

For any further information : M. Gilles RICHARD – General Secretary

Biesterfeld is a participant in the UN Global Compact – a network initiated by the UN in order to shape the process of globalisation, both socially and ecologically. With this sustainability report, Biesterfeld demonstrates its commitment to the 10 principles of the UN Global Compact concerning human rights, labour, the environment and anti-corruption. For the report, Biesterfeld uses the guidelines of the independent Global Reporting Initiative, the organisation which also certified the report. This ensures that both data and initiatives related to sustainability are described in comprehensive detail.

In addition, the report is standardised to allow for comparison of sustainability data between individual companies.

Source and information

IMCD reaches agreement on the acquisition of Selectchemie in Brazil

UFCC legal training course Last 24th of November, UFCC organized a specific training course for its members regarding legal aspects of distribution contracts at European and national levels in the chemical supply chain, mainly between producers and distributor. Nearly 25 participants attended this seminar. Most of them were CEO and sales managers.

Its objective was to give companies reading keys regarding trading relations between any furnisher and its clients according to its statutes (commercial agent, broker..) and kinds of distribution agreements.

A comprehensive analysis of commercial negociation was also made : terms of sales, terms of purchase, prices negotiability, payment period, billing rules. The day ended on a very specific French provision : the “Annual Convention”. This document is mandatory when a furnisher (producer, importer..)

IMCD N.V., a leading distributor of specialty chemicals and food ingredients, announced that is has reached agreement on the acquisition of all of the outstanding shares of Selectchemie LTDA in Brazil ("Selectchemie").

Selectchemie, based in Sao Paulo, was founded in 1970 and is owned by Selectchemie AG of Switzerland and two of the current managers. Selectchemie is the leading distributor of pharmaceutical ingredients in Brazil, representing world leading producers from the US, Europe and Asia. The portfolio includes an extensive range of excipients and active pharmaceutical ingredients which complements IMCD's existing position in Brazil.

Dr John Robinson, director IMCD Business Group Pharmaceuticals says: "The acquisition of Selectchemie is an excellent fit with our business as we continue to align with world class suppliers of pharmaceutical ingredients on a multi-regional basis. We recognize Brazil to be a dynamic market for the generic pharmaceutical industry and it is our intention to utilize our formulation expertise to provide solutions to both our customers and suppliers."

Walter Thuring, managing director of Selectchemie says: "We are excited about the potential of combining our knowledge of the growing Brazilian market with IMCD's global reach and strong technical formulation expertise."

8

Members’ news In 2014, Selectchemie generated revenues of BRL 68 million with 43 staff. After completion of the acquisition, which is expected before the end of 2015, the company will continue with its present management and staff.

integrated oleo chemical and personal care manufacturing facility in Malaysia. In turn, EVYAP stands to benefit from NRC’s strong logistic network and extensive customer base in Europe.

Source and Information

Patrick Knüppel, NRC’s General Manager of Oleochemicals & Lubricants, remarks optimistically: “Both existing and new customers will profit from this new partnership by having access to EVYAP’s natural oil-derived oleochemical products, along with the well-known service and supply chain solutions offered by NRC.”

Major shareholder Bain Capital places 4 million shares of IMCD with institutional investors IMCD N.V., a leading distributor of specialty chemicals and food ingredients, announced that is has been informed that Emma (BC) Holding S.C.A., an entity indirectly controlled by the investment funds managed by Bain Capital Investors, LLC (“Bain Capital”), the major shareholder of IMCD, has placed 4 million IMCD shares at EUR 33.60 per share with institutional investors in an accelerated bookbuilding process.

Following this transaction, Bain Capital now holds 7.9% in IMCD, increasing the free float to 92.1%. The transaction was led by Goldman Sachs International and Deutsche Bank AG, London Branch.

New distribution partner: NRC signs agreement with EVYAP

Fatty acids and glycerine are important ingredients for the production of soaps and detergents and being used in more than 2,000 applications for everyday life. ‘’Our customers trust us because we offer excellent quality. We are known for building reliable customersupplier relationships. Therefore NRC is the ideal partner for us in Europe’’ Dr. Martin Rudolph, Vice Chairman, says.

Dr. Gerd Bergmann, Managing Director at Nordmann, Rassmann, completes “The new partnership with EVYAP is the next milestone for NRC in expanding the company’s core activities towards green chemicals. With EVYAP, we’ve found the right company to grow this segment successfully.” Source and information

STANHOPE & Thon HOTELS DISCOUNT—10% OFF !

Go to : http://www.thonhotels.com/ log-in/

Nordmann, Rassmann is pleased to announce a new partnership: as of 1 December 2015, the long-standing, Hamburgbased company will be marketing and supplying EVYAP SABUN MALAYSIA SDN BHD (EVYAP)’s oleochemical product range of fatty acids and glycerine to customers in Europe.

Benefit from 10% reduction on their Best Available Rate in all of their Brussels Hotels Customer number: TH21779613 Company name: FECC

The strategic partnership presents a win-win situation for both companies: with EVYAP, NRC has gained one of the leading producers of oleochemicals in Malaysia. Evyap Sabun Malaysia (ESM), a Turkish based company with its headquarters in Istanbul, Turkey, is no stranger to the Oleo Chemical industry in South East Asia. ESM has a state of art and fully 9

Members’ news

Telko to represent ENGEL in Baltic countries Since September 2015 Telko Ltd, part of Aspo Group, has represented ENGEL AUSTRIA in the Baltic countries. Telko sells ENGEL's injection moulding machines and system solutions to its plastic processing clients. In addition to sales activities Telko will provide spare parts and maintenance services to customers.

Tatiana Sorokina, Dmitry Sergeev, Olga Poichenko are included in the team and will report directly to Maia.

Maia will also manage all automotive projects in Plastics Russia and coordinate all automotive cases together with Lubricants and Chemicals in one line.

Maia Shioshvili will keep reporting to Sales Director Plastics Russia, but there will be an interim change of Sales Director in Plastics Russia.

Telko has operated in the Baltic countries for 20 years and its local offices located in Estonia, Latvia and Lithuania serve the customers in the regions with high efficiency and speed. Telko is strengthening its organization with additional technical and commercial personnel.

Svetlana Khovstikova, Sales Director of Plastics in Telko Russia, will be taking her maternity leave effective at the end of November 2015. In her absence, Juris Avotins, Managing Director of Telko Russia and Sales Director of Plastics in Kazakhstan and Belarus, will be assuming the responsibilities.

Telko represents several leading plastic raw material producers with an extensive product portfolio. Telko customers include the packaging, construction, electronics and electricity industries as well as companies manufacturing plastic parts for consumer products.

Please join us for wishing Ilya and Maia the best of luck with their new responsibilities and all the best to Svetlana in her private life for coming months and well deserved maternity leave. Source and information

"Telko is very excited to represent the world class machinery producer ENGEL. We believe the high-performance, energy efficient ENGEL products combined with our market experience, customer intimacy and product offering will prove to add high value to Baltic injection moulding companies", comments Kalle Kettunen, Managing Director of Telko. Source and information

Organizational announcements in Telko Russia In Telko Lubricants Russia has appointed Mr. Ilya Shteba to Sales Manager Lubricants Russia. Ilya Shteba started in Telko at the end of October.

Ilya will be responsible as Sales Manager for Russia West Region and he is based in St Petersburg office.

Ilya has long experience in lubricants sales and excellent product knowledge. The last eight years he has been working for different distributors representing European lubricants brands. He will report to Per Rosenberg, Vice President of Telko Lubricants.

In order to keep and develop further business in automotive area in Plastics Russia, Maia Shioshvili is appointed as Automotive Team Leader from November 16, 2015.

Brenntag extends the distribution of Vantage specialty cleaning products into Ireland Brenntag, the global market leader in chemical distribution, announces that from January 1st, 2016, it will distribute the specialty cleaning range of Vantage Specialty Chemicals Ltd in Ireland (North & South).

Maura Joliffe, Head of Material Science, Brenntag UK Ltd. says: “We are delighted to be extending our existing distribution agreement with Vantage in Great Britain to cover Northern Ireland, whilst also taking over responsibility for the distribution of products into the Republic of Ireland through our sister company Brenntag Chemicals Distribution (Ireland) Limited. The addition of Vantage’s high performance range of precision cleaning products for metal surface treatment allows us to offer an even stronger portfolio to our customer base across a number of specialty markets including the aerospace, automotive, electronics and medical device sectors.”

Dirk Budde, Regional Sales Manager EMEA, Vantage Specialty Chemicals states, “Our goal is to expand the sales of Vantage brands and increase our footprint throughout Ireland.

The partnership with Brenntag UK Ltd and Brenntag Chemicals Distribution (Ireland) Ltd is a proven and reliable basis for growing our international business.” Source 10

EU Chemicals Legislation 1.

REACH 2018

ACT NOW BEFORE IS TOO LATE! Know your portfolio You need to identify those substances which are subject to registration by 31 May 2018. Refresh your knowledge on REACH duties and decide for which substances you want to continue on the market.

Identify your substances correctly Unambiguous and correct identification of your substances is essential to a successful and compliant regis-tration.

Find your co-registrants

In addition, the lists of use descriptors have been updated, including a new use descriptor (Life cycle stage) and some modifications of the descriptors already available.

An appendix on how to manage these changes has also been included.

R.12 Guidance: http://echa.europa.eu/ documents/10162/13632/ information_requirements_r12_en.pdf 4.

New substance infocards - more useful and transparent information on chemicals In January 2016, ECHA will change the way in which you will see chemicals data on the website. Information on up to 120 000 chemicals will be structured in three layers: Infocard, Brief Profile and detailed source data

Find who intends to register. Many substances have already been registered but there is a large list of substances that have not been registered yet, and that won't be registered if no action is taken now.

For more information on 2018 registration: http:// echa.europa.eu/reach-2018 2.

Inspectors’ safety data sheet checklist available

A safety data sheet checklist, developed in cooperation with the Enforcement Forum, is available in 23 languages on ECHA’s website. Its main purpose is to support inspectors in their examination of safety data sheets, but it can also be used by companies to improve the quality of safety data sheets in the supply chain.

For more information: http://echa.europa.eu/web/guest/ regulations/reach/safety-data-sheets 3.

Updated Guidance on use descriptors R.12 published The Guidance update aims to support registrants in improving the description of uses of their chemicals mainly in the context of the registration dossier.

The Guidance update aims to support registrants in improving the description of uses of their chemicals mainly in the context of the registration dossier.

The scope of the guidance document has been extended from the system of use descriptors to also cover the principles and elements for describing the uses of chemical substances, the role that the use descrip-tion plays in different REACH processes, and the related legal requirements.

The most impressive new feature is the Infocard, which offers a summary of the key information on a substance in plain English. "Users will be able to see at a quick glance the key properties of the substance: how it is classified and whether it is hazardous or not. For more information: http://newsletter.echa.europa.eu/home/-/ newsletter/entry/5_15_new-substance-infocards-moreuseful-and-transparent-information-on-chemicals 5.

New case study for assessing chemical hazards with the QSAR Toolbox ECHA has published a new illustrative example which demonstrates what elements need to be taken into account when predicting long-term toxicity to fish with the QSAR Toolbox.

There are now examples available on four different endpoints: •

Skin sensitisation

• Short-term toxicity testing on invertebrates (preferred species Daphnia) •

Short-term toxicity testing on fish

•

Long-term toxicity testing on fish

For more information: http://www.echa.europa.eu/ web/guest/support/oecd-qsar-toolbox 11

EU Chemicals Legislation

6.

Forum publishes REACH EN FORCE 3 results

1 169 companies and 5 746 substances were inspected in 2013-2014. In total, 13 % of companies did not fulfil some of their registration obligations. In most of these cases, the non -compliant companies failed with registration duties related to one or two substances from their portfolio. However, 2 % of companies had not registered any substances at all.

Only representatives, who register substances on behalf of importing downstream users, are more likely to be in breach of their REACH-related obligations than other registrants. A third of 104 OR inspected (32 %) did not comply with their specific only representative information duties as described by Article 8 of REACH. The flow of information in the supply chain between only representatives and importing downstream users was also poor. It was often difficult to establish the structure of the supply chain as the respective importers could not specify the correct only representative and the only representatives did not keep reliable records of represented importers.

For more information: http://echa.europa.eu/viewarticle/-/journal_content/title/many-companies-still-miss

7.

Forum starts projects on internet trade of chemicals and on substances in articles At its November meeting, the Forum for Exchange of Information on Enforcement decided on two new pi-lot projects. In 2016, a pilot project will focus on internet sales of chemicals. The intention is to enforce that legal provisions are complied with (e.g. appropriate information is provided to customers) when substances and mixtures are offered for sale on the internet. The pilot project for 2017 will focus on enforcing the provisions for substances in articles in REACH. For more information: http://echa.europa.eu/view-article/ -/journal_content/title/forum-starts-projects-on-internettrade-of-chemicals-and-on-substances-in-articles

8.

Call for evidence on isocyanates

Germany is working on a restriction proposal and invites anyone with information onisocyanates (EC 927-229-7) to complete a short survey.

The purpose is to gather information on the uses, handling and exposure of diisocyanates and diisocyanate containing products, and about alternative substances for specific applications that you might be aware of. The call will close on 1 December 2015. A possible public consultation on the restriction proposal itself will follow in due time.

For more information: http://www.reach-clp-biozidhelpdesk.de/en/REACH-en/Restriction/German% 20proposals%20for%20restriction/Proposal_Diisocyanates/ Proposal_Diisocyanates.html 9.

Do you have information on alternatives to uses of chromium trioxide?

ECHA has launched a public consultation on two applications for authorisation covering three uses of chromium trioxide (EC 215-607-8; CAS 1333-82-0) in the electroplating sector. More information about the uses that authorisation is applied for, including the description of the function of the substance, expo-sure scenarios, possible alternatives identified by the applicants, together with socio-economic infor-mation, is available on ECHA’s website. Comments can be submitted until 7 January 2016 (23:59 Helsinki time) For more information: http://echa.europa.eu/addressing -chemicals-of-concern/authorisation/applications-forauthorisation 10.

Minutes of committee meetings available

The final minutes of the September meetings of the Committee for Risk Assessment (RAC) and the Committee for Socio-Economic Analysis (SEAC) are available on our website.

RAC-34 minutes: http://echa.europa.eu/ documents/10162/21961120/rac_34_minutes_en.pdf SEAC-28 minutes: http://echa.europa.eu/ documents/10162/21959512/seac_28_minutes_en.pdf

For more information on Chemicals Legislation, please contact: Irantzu Garmendia +32 2 679 02 68 iga@fecc.org 12

EU Chemicals Legislation

11.

Authorisation grant for two trichloroethylene

The Commission Implementing Decision granting an authorisation for some uses of trichloroethylene trichloroethylene (EC 201-167-4; CAS 79-01-6): as a solvent for the removal and recovery of resin from dyed clothand as a solvent in a process to recover and purify resin from process water was adopted on 24 No-vember 2015: The review period for the authorisation will expire on 21 April 2028.

A summary of the decision: http://eur-lex.europa.eu/ legal-content/EN/TXT/?toc=OJ%3AC%3A2015%3A392% 3ATOC&uri=uriserv%3AOJ.C_.2015.392.01.0007.01.ENG REACH Authorisation Decisions: http://ec.europa.eu/ DocsRoom/documents/8962/attachments/1/ translations/en/renditions/native 12.

New chemicals to fall under export notification obligation Annex I to the PIC Regulation lists those chemicals that require an export notification before they can be exported outside the European Union. The notification should be submitted to the Member State authorities at least 35 days before the expected date of export through the IT tool ePIC. This list has been amended with 12 new entries, which cover a total of 143 chemicals. The amendment will enter into force on 1 February 2016. To continue exporting these chemicals without interruption, a notification should already be submitted in December 2015.

The new entries included in Annex I to PIC are: •

1,1-Dichloroethene

•

1,1,2-Trichloroethane

•

1,1,1,2-Tetrachloroethane

•

1,1,2,2-Tetrachloroethane

•

Dibutyltin compounds

•

Dioctyltin compounds

•

Fenbutatin oxide

•

Lead compounds

•

Pentachloroethane

•

Trichlorobenzene

Additionally, the following entries are added only to Annex I part 3 and exports of these chemicals are banned (with the exception of quantities below 10 kg per year per importing country for research and analysis purposes).

• ing

Commercial pentabromodiphenyl ether, includ-

tetrabromodiphenyl ether pentabromodiphenyl ether •

Commercial octabromodiphenyl ether, including hexabromodiphenyl ether heptabromodiphenyl ether

The amendment was published in the Official Journal of the European Union on 3 December 2015.

13.

Registry of Intentions updated and new submitted proposals and withdrawn intentions and submissions Harmonised classification and labelling New intentions: • mesotrione (ISO); 2-[4-(methylsulfonyl)-2nitrobenzoyl]-1,3-cyclohexanedione (CAS 104206-82-8) by United Kingdom • branched hexatriacontane (or Alkane 4) (EC 417070-7; CAS 151006-62-1) by the United Kingdom.

Submitted proposals • empenthrin (ISO); (E)-(RS)-1-ethynyl-2-methylpent2-enyl-(1R,3RS)-2,2-dimethyl-3-(2-methylprop-1-enyl) cyclopropanecarboxylate (CAS 918500-11-5) submitted by Belgium • 1,2-benzenedicarboxylic acid, di-C8-10branched alkyl esters, C9-rich; [1] di-''isononyl'' phthalate [2] (EC 271-090-9; CAS 68515-48-0) submitted by Denmark • titanium dioxide (EC 236-675-5; CAS 13463-677) submitted by France • thiabendazole (ISO); 2-(1,3-thiazol-4-yl)-1Hbenzimidazole (EC 205-725-8; CAS 148-79-8) submitted by Spain.

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EU Chemicals Legislation SVHC New intentions: Germany plans to submit a dossier SVHC dossier on benzo[def]chrysene (benzo[a]pyrene) (EC 200-028-5; CAS 50-32-8).

The expected submission date is 1 February 2016.

Withdrawn Dicyclohexyl phthalate (CE 201-545-9; CAS 84-61-7) By Sweden Restriction Withdrawn Bisphenol A,4,4'-isopropylidenediphenol ( CE 201-245-8: CAS 80-05-7) By Sweden For more information: http://echa.europa.eu/addressing-chemicals-of-concern/registry-of-intentions

Responsible Care and Logistics

Fecc Responsible Care Committee Meeting 2016 - Brussels The next Fecc Responsible Care Committee meeting will be held on 10 March 2016 at Fecc offices, in Brussels.

For enquiries, please contact Gerhard Ahlbrecht at gah@fecc.org

For more information on Responsible Care and Logistics , please contact: Gerhard Ahlbrecht at +32 2 679 02 64 gah@fecc.org

14

International Trade News

EU and Vietnam finalise trade deal The European Union (EU) and Vietnam have finalised talks for a free trade agreement (FTA), marking the end of the negotiating process. As well as unlocking a market with huge potential for EU firms, the agreement will support Vietnam's transition towards a more competitive, smarter and greener economy. It will also help trigger a new wave of high quality investment in both directions, supported by an updated investment dispute resolution system. EU exports to Vietnam are dominated by high tech products including electrical machinery and equipment, aircraft, vehicles, and pharmaceutical products. Vietnam's key export items to the EU include telephone sets, electronic products, footwear, textiles and clothing, coffee, rice, seafood, and furniture.

Source: DG Trade – http://trade.ec.europa.eu/doclib/press/ index.cfm?id=1409

India, EU trade pact talks early next year Chief negotiators of India and the EU will meet early next year to take the talks further on the trade and investment pact. So far 15 rounds of negotiations have been held between India and the European Union on Bilateral Broad Based Trade and Investment Agreement (BTIA).

The case threatens a deal that had expanded duty-free status to dozens of Moroccan agricultural and fisheries products imported to the EU. However, officials said the judgment should have no immediate impact on commerce between the two sides, which totalled close to €30 billion ($32.8 billion) last year. The European Union Foreign Affairs Council has appealed this ruling on the EU-Morocco agriculture agreement Source: Morocco World News - http:// www.moroccoworldnews.com/2015/12/175130/euforeign-affairs-ministers-appeal-ecjs-ruling-on-eumorocco-agriculture-agreement/

Canada’s fresh push for EU trade deal Canada’s new government is pushing the EU to move faster on a delayed trade deal, including a potential compromise on the key sticking point holding the deal up.

Canada is open to compromise on the EU’s demands for an international court on investment protection. Although Ottawa and Brussels concluded their negotiations on the deal back in September 2014, controversy over the so-called investor state dispute settlement (ISDS) mechanism has stalled efforts to ratify and implement the agreement since then.

Source: http://www.politico.eu/article/canada-tradedeal-ttip-ceta-malmstrom-trudeau/

Source: Economic Times India http://economictimes.indiatimes.com/ articleshow/50172522.cms? utm_source=contentofinterest&utm_medium=text&utm_ca mpaign=cppst

Court Annuls EU Trade Accord With Morocco The European Court of Justice's (ECJ) has ordered a 2012 trade pact between the EU and Morocco annulled, saying the agreement should not apply to Western Sahara, a disputed territory claimed by Morocco.

15

GTDP News

QP Declaration: Q&As by the CMDh-Group In 2014, the European Medicines Agency (EMA) published a Qualified Person (QP) declaration template together with a guidance document. This template provides a basis for demonstrating compliance of the API-manufacture with the current GMP requirements and a relevant knowledge of the supply chain. However, the past year has shown that there are still uncertainties and open questions. The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) has now published a document to summarize the most frequent Q&A’s asked by the stakeholders regarding the two EMA documents.

Source: Maas & Peither GMP Publishing - https://www.gmp-publishing.com/en/gmp-news/gmp-aktuell/qualified-person -questions-answers-2015-EMA.html

Label pictogram for EU-sourced medicinal products?

The government of France has proposed a new labelling claim to the European Commission – a pictogram – indicating that the manufacturing operations of excipients, the manufacturing of the active substance, its production or packaging were carried out within the territory of the European Union or Member States of the European Free Trade Association (EFTA). The pictogram would be shaped a rectangle divided in four equal parts which correspond to the four categories active ingredient, excipients, production and packaging. If a component was e.g. produced in the EU or a member state of the EFTA, the category would bear the word “Europe” in white letters on a blue background. Ingredients made outside Europe would simply carry a black cross.

A feedback at the European level is pending, so far.

Source: https://www.gmp-publishing.com/en/gmp-news/gmp-aktuell/pictogram-france-made-in-eu-medicinalproducts.html

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

16

EU and Other News

Maximising the contribution of the European Structural and Investment Funds to the Commission's priorities

On December 14, the Commission adopted a Communication on the contribution of the European Structural and Investment Funds (ESI Funds) to the EU's growth strategy, the Investment Plan and the Commission's priorities over the next decade.

The Commission adopted a Communication on the contribution of the European Structural and Investment Funds (ESI Funds) to the EU's growth strategy, the Investment Plan and the Commission's priorities over the next decade. The report also includes the outcomes of the negotiations with all the Member States on Partnership Agreements and programmes and the key challenges per country.

Vice-President Jyrki Katainen, responsible for Jobs, Growth, Investment and Competitiveness, said: "There is a huge potential to combine ESI Funds and the Investment Plan's European Fund for Strategic Investments (EFSI), but local and regional authorities may not be aware. That is why Commissioner Crețu and I will soon issue guidelines on the complementarity of the Funds, to make sure Member States make full use of these new opportunities."

Paris UN climate change conference, 30/11-12/12/2015 From 30 November to 12 December, Paris hosted the 21st session of the Conference of the Parties (COP 21) to the United Nations Framework Convention on Climate Change (UNFCCC) and the 11th session of the meeting of the parties to the Kyoto Protocol (CMP 11).

On 12 December, the parties reached a new global agreement on climate change. The agreement presents a balanced outcome with an action plan to limit global warming 'well below' 2°C. Carole Dieschbourg, Environment Minister for Luxembourg, holding the presidency of the Council, said: "Today is a day to be proud. We have agreed the first-ever legally binding and universal climate agreement which puts the world on course to avoid dangerous climate change. It is a roadmap for a better, more just and sustainable world. The EU fought for this agreement to be as strong as possible. We have been a successful bridge builder throughout these negotiations. But let's not forget that Paris is only the beginning of a long journey. Together with all the stakeholders - NGOs, the business community and every citizen -we will now have the responsibility to translate this agreement into actions."

Donald Tusk, President of the European Council, joined 150 other leaders at the opening event on 30 November 2015.

The Council formally adopted a negotiating position for the conference in September this year.

Commissioner for Regional Policy Corina Creţu said: "The ESI funds are increasingly needed as national and regional investments are declining. They robustly support Europe's return to lasting prosperity, by targeting the most promising sectors, bringing more cohesion and convergence in the EU and helping regions and cities capitalize on the talent and ideas of their people. It is now up to the Member States to efficiently manage and invest the Funds, so they can reach the objectives detailed in the Communication."

Read more 17

EU and Other News

The European Commission publishes its long awaited Circular Economy package Last week the European Commission published the awaited Circular Economy package. The new package presented is driven by the Commission’s Better Regulation agenda, focusing on effective monitoring, setting realistic targets, and linking it to existing and upcoming EU initiatives. Vice-President Jyrki Katainen, in charge of Jobs, Growth, Investment and Competitiveness, stressed that the new package is especially about the economy and boosting competitiveness. It shows that while its plan remains ambitious, the Commission has taken the strategic decision to take a more realistic and holistic approach.

The Circular Economy package consists of legislative proposals on waste and an action plan encompassing a set of actions to be carried out under the current Commission’s mandate: • A Communication on circular economy: “Closing the loop – An EU Action Plan for Circular Economy”. This Communication sets out a roadmap for the coming years regarding circular economy. The objective “is to preserve and maintain the value of products, materials and resources in the economy for as long as possible, while minimising the generation of waste.”

•

A proposal for a Directive amending Directive 2008/98/ on waste;

•

A proposal for a Directive amending Directive 94/62/EC on packaging and packaging waste;

•

A proposal for a Directive amending Directive 1999/31/EC on the landfill of waste;

• A proposal for a Directive amending Directive 2000/53/EC on the end-of-life vehicles, 200/66/EC on batteries and accumulators and waste batteries and accumulators and 2012/19/EU on waste Electrical and Electronic Equipment.

More information is available via the following link: http://ec.europa.eu/environment/circular-economy/index_en.htm http://ec.europa.eu/priorities/jobs-growth-investment/circular-economy/docs/communication-action-plan-for-circulareconomy_en.pdf http://ec.europa.eu/priorities/jobs-growth-investment/circular-economy/docs/annex-communication-action-plan-forcircular-economy_en.pdf

UPCOMING EVENTS 2016 IPEC Europe Excipients Forum 4 February 2016, Nice (FR) Our next annual event will take place on 4 February 2016 in Nice, France at the prestigious Negresco Hotel.

The 2016 event will address topics such as risk assessment for excipients, ICH Q3D, EXCiPACT Certifying Body experience, QbD and also the use of excipients in paediatrics.

We are looking forward to welcoming you in Nice! Tofind out more, click here

18

Calendar Date

Meeting

Location

December Year 2016 Date

Meeting

Location

GTDP Symposium

Sheraton Brussels, Airport

1

Board Meeting

Fecc, Brussels

8

Biocidal Products TF

Fecc, Brussels

9

SHE Committee

Fecc, Brussels

10

Responsible Care

Fecc, Brussels

19

ESAD Steering Committee

Cefic, Brussels

28

Logistics Committee

Fecc, Brussels

Precursors Committee

Fecc, Brussels

5

Board Meeting

Istanbul

6-8

Fecc Annual Congress

Istanbul

SHE Committee

Fecc, Brussels

27

Board Meeting

Hamburg

29

ESAD Steering Committee

Fecc, Brussels

Logistics Committee

Fecc, Brussels

Board Meeting

Brussels

January 27 March

April

May 4 June

August 30 September

October 26 November 23

19

Contact us!

Fecc secretariat +32 2 679 02 60 Uta Jensen-Korte, Director General ujkatfecc.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 Irantzu Garmendia, Technical & Regulatory Affairs Manager (HSE) iga@fecc.org Marie-Hélène Laplagne, Administrative Assistant assistantfecc@fecc.org

Owner and Publisher: The European Association of Chemical Distributors (Fecc) Rue du Luxembourg 16B, B-1000 Brussels, Belgium www.fecc.org Chief editor: Alexandra Mengesha - Communications and Membership Development Manager +32 2 679 02 63, ame@fecc.org Editorial staff: Fecc Policy Managers Pictures: Shutterstock, PSD Graphics, member companies and privat 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 endorsement of the views expressed within them.

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