Issue 8– December 2014
s! s e ucc OR S ur o NS O e rat A SP b le ME Ce AY O D C TO BE
Inside this issue Members’ news Fecc Activities EU Chemicals Legislation GTDP International Trade
2 7 9 14 16
EU & Other News Calendar 17
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Members’ news
Banner Chemicals UK acquires Stowlin Ltd Solutions for metals surface treatment, cleaning and phosphating We are delighted to advise you that the shareholders of Stowlin Ltd and of Banner Chemicals Ltd UK have agreed to join forces. Banner Chemicals Ltd UK will acquire the entire share capital of Stowlin Ltd from Mr Nigel Sullivan. We are pleased that Nigel will continue to lend his support and expertise as consultant to the business. Stowlin’s customers will enjoy a seamless service as operations, sales and marketing activities will continue as usual from the Leicester based site. The joint portfolio of Banner’s PCS (Precision Cleaning Solutions) Business Unit and Stowlin will provide customers with an enhanced and complete range of solutions for metal surface treatment, cleaning and phosphating. Source and information
Brenntag (WKN A1DAHH), the global market leader in chemical distribution, reports solid growth in gross profit and operating EBITDA in the third quarter of 2014. In the third quarter of 2014, sales increased by 3.9% to EUR 2,587.2 million on a constant currency basis (3.9% as reported). Gross profit*, a key performance indicator for Brenntag, increased by 4.5% year-on-year to EUR 520.3 million on a constant currency basis (4.6% as reported). Operating EBITDA** increased by 3.1% year-on-year to EUR 189.1 million on a constant currency basis (3.2% as reported). Brenntag’s profit after tax amounted to EUR 86.3 million in the third quarter. Accordingly, the Brenntag shareholders’ earnings per share amounted to EUR 0.56 and were thus higher compared to the same quarter of the previous year (Q3 2013: EUR 0.52). Brenntag’s free cash flow totalled EUR 324.2 million in the first nine months of the year, compared to EUR 338.5 million in the prior-year period. Source and more information
Eastman Chemical appoints ICH Benelux as new distributor in Benelux Eastman Chemical BV has expanded its distribution network and appoints ICH Benelux BV as its new distributor in Benelux. The cooperation will start January 1, 2015 and covers all Eastman TM products for paint and coatings applications. Eastman Chemical is one of the leading specialty chemical producers worldwide. Its product range comprises Cellulose Esters, TexanolTM ester alcohol, OptifilmTM Enhancer 300, Chlorinated Polyolefines, SAIB, Ketones and various Solvents. ICH Benelux, located in Zaandam near Amsterdam, is a distributor with a strong focus to the coatings industry. Since 2013 ICH Benelux belongs to the German based Krahn Chemie group, a specialty chemical distribution company which also provides inhouse laboratory services. Eastman Chemical and Krahn Chemie have been working successfully together in the German market for many years already. Source and information
Members’ news
Nordmann, Rassmann takes over distribution of Stepan products Nordmann, Rassmann has a new distribution partner: as of now, NRC is marketing the company Stepan's polyester polyols to the Scandinavian countries. Distribution in Germany and Austria will follow as of 1 January 2015. Stepan's product portfolio contains commercial and industrial surfactants, nutritional oils and polyester polyols for rigid and flexible foam. With the company's 2013 acquisition of Bayer's MaterialScience polyester polyol business from the former plant in Columbus, Ohio (USA), Stepan was able to consolidate its market position in this part of North America and gain a state-of-the-art production facility. In combination with their Polish site in Brzeg Dolny, Stepan is now expanding business into the CASE (coatings, adhesives, sealants and elastomers) markets with its STEPANPOL ® product range. In Europe, NRC is currently distributing the following products in the Nordic countries via its subsidiary KEMI-INTRESSEN and will be marketing them soon in Germany and Austria: STEPANPOL® aliphatic polyester polyols - these offer greater light stability and non-yellowing properties while providing durability, solvent resistance and tear strength. STEPANPOL® aromatic polyester polyols - these make use of phthalic anhydride to take advantage of ortho-ester linkage, thereby delivering enhanced hydrolytic stability and diverse substrate adhesion while simultaneously improving abrasion resistance and overall hardness. The major end uses for these CASE polyesters include liquid and hot melt urethane adhesives, cast elastomers, thermoplastic polyurethanes and polyurethane dispersions, as well as energy cure and conventional cure surface coatings. With the complete portfolio of aliphatic and aromatic polyester polyols, NRC's new cooperation partner underscores its commitment to being the global market leader in esterification. The publicly-traded manufacturer of specialty and intermediate chemicals was founded in Chicago in 1932. Source and information
Biesterfeld Spezialchemie: Distributor for Dr. Straetmans productportfolio in Russia Biesterfeld Spezialchemie GmbH and Dr. Straetmans GmbH, both headquartered in Hamburg, further expand their successful cooperation. Effective since August 2014, Biesterfeld Spezialchemie in Russia has taken over the distribution of Dr. Straetmans’ product portfolio. The successful partnership started in 2008 when Biesterfeld Spezialchemie started to promote the Dr. Straetmans products in Eastern Europe. “We are very pleased to expand the great partnership with Dr. Straetmans. Their innovative product portfolio offers additional attractive cosmetic ingredients to our Russian customers,” says Inge Gotthardt, Business Manager LifeScience, Biesterfeld Spezialchemie GmbH. Dr. Straetmans is well known as a leading supplier of multifunctional products for the cosmetics industry with a focus on cosmetic ingredients from renewable raw materials and products that conform to natural cosmetic guidelines. Besides a wide range of emollients, PEG-free emulsifiers and natural antioxidants, Dr. Straetmans also offers preservative blends. Source and for more information
Members’ news
Transaction completed between Wintershall and Statoil BASF Group company Wintershall is continuing its growth course in Norway. By acquiring shares in the production fields Gjøa (5%) and Vega (24.5%), Wintershall is increasing its production in Norway from about 40,000 barrels of oil equivalent (boe) to about 60,000 boe per day. In addition, Wintershall is taking over shares in the Aasta Hansteen development project (24%), the Asterix discovery (19%), the Polarled pipeline project (13.2%) and in four exploration licences near Aasta Hansteen. The shares in the assets encompass reserves and resources (2P/2C) of around 170 million boe. Furthermore, Wintershall will also assume the operatorship of the Vega production field.[1] The transfer of operatorship from Statoil to Wintershall is planned for the end of the first quarter of 2015. For more source and information
Production in Norway rises to 60,000 barrels of oil equivalent per day BASF Group company Wintershall is continuing its growth course in Norway. By acquiring shares in the production fields Gjøa (5%) and Vega (24.5%), Wintershall is increasing its production in Norway from about 40,000 barrels of oil equivalent (boe) to about 60,000 boe per day. In addition, Wintershall is taking over shares in the Aasta Hansteen development project (24%), the Asterix discovery (19%), the Polarled pipeline project (13.2%) and in four exploration licences near Aasta Hansteen. The shares in the assets encompass reserves and resources (2P/2C) of around 170 million boe. Furthermore, Wintershall will also assume the operatorship of the Vega production field.The transfer of operatorship from Statoil to Wintershall is planned for the end of the first quarter of 2015. 1— Wintershall has purchased the shares for US$1.25 billion. The transaction is financially effective retroactively to January 1, 2014. A further payment of up to US$50 million will be made once Aasta Hansteen has been developed in accordance with the current project plan. Additionally both companies have agreed to work together in developing the exploration potential of the Vøring Basin . More information
Algol Chemicals and Omya will establish a joint venture in Russia for distribution of calcium carbonate and specialty chemicals Algol and Omya have agreed to establish a Joint Venture in Russia to strengthen their activities in the Calcium Carbonate and Specialty Chemicals distribution. Omya Algol Rus will provide to customers and principals in polymers, paints and coatings, food, personal care and agricultural industries a one-stop-shop opportunity as well as provide the customers with high-value services. Omya Algol Rus builds a strong platform for future growth in the large and rapidly growing Russian market for Specialty Chemicals and value added Calcium Carbonate products. See more at: http://www.algol.fi/en/news-and-releases/
DKSH assesses Wörwag Pharma’s market expansion potential in Asia DKSH Business Unit Healthcare, the leading partner for healthcare companies seeking to grow their business in Asia, evaluates the feasibility of registering Wörwag Pharma’s major products in Cambodia, Korea, Laos, Malaysia, Myanmar, the Philippines and Singapore. The regulatory feasibility assessment will provide answers to core questions that companies face when thinking about entering new markets. Among other topics, the detailed assessment provides an overview of information and documents required to register, the duration and price of the registration, as well as potential upcoming changes in local regulations that might influence the registration process. Source and more information
Members’ news Brazil and across Latin America,” said Univar President and Chief Executive Officer Erik Fyrwald. “D’Altomare’s portfolio of specialty ingredients, coatings, lubricants, and adhesives are a complimentary addition to our existing product portfolio. In addition, D’Altomare has a solid reputation as a value- added and solutions-driven service provider in high-growth specialty markets including personal care, pharmaceuticals, electronics and aviation.” For more than 40 years, D’Altomare has Univar Inc., a leading global chemical specialized in the distribution of chemisdistributor of industrial and specialty tries and specialty ingredients for the chemicals and related chemistry serpharmaceutical, personal care, food, vices, announced today it has acquired agriculture, transportation and other D'Altomare Química Ltda., a Brazilian industrial markets. The company has distributor of specialty chemicals and headquarters in São Paulo, and operates ingredients, through Univar Brasil Ltda. The acquired business will be combined distribution facilities in Embu and Manaus. with Univar’s Brazil operations. “This transaction expands Univar’s geo- “We are confident that the opportunity graphic footprint and market presence in of combining D’Altomare with Univar will
Univar Expands in Brazil Market with Acquisition of D’Altomare Química Ltda
offer new potential not only for our customers, but also our suppliers and employees,” said Nita Zoppetti, major shareholder of D’Altomare.
IMCD and Campine extend partnership for flame retardant masterbatches IMCD N.V. and Campine N.V. announce the extension of their distribution partnership for flame retardant masterbatches into Spain. This agreement is a complementary addition to IMCD’s compounders and converters product portfolio and consolidates Campine’s distribution network in Europe. Campine has been delivering expertise and a reliable service to its customers in the non-ferrous and plastics industry since 1912 and is a global specialist in flame retardant masterbatch solutions. Marc Liegeois, Campine Business Manager Plastics, comments: “IMCD has represented Campine’s flame retardant
masterbatches for more than 10 years in the Nordics, South East Europe and Poland. Together, we hope to replicate this success and significantly increase our sales activities in existing and new regions.” Stefan Hansson, IMCD Product Manager Plastics Sweden, adds: “This is a very exciting opportunity for IMCD to build on its existing partnership with Campine and enhance our services to the plastics market. As Campine recently reorganised its masterbatch division, it seemed the opportune time to begin to consolidate and develop the business.” Source and more information
Azelis opens a premium class Laboratory Suite in the UK Azelis has made a significant investment in laboratory facilities at its UK site in Hertford as part of a strategic review across its businesses;designed to drive sustainable, profitable growth and extend value-added services for principals and customers. A premium class suite comprising Personal Care, Homecare and Pharma laboratories opened in November 2014, enhancing Azelis’ capabilities for formulation and technical support, trouble-shooting advice, business generation, ingredient approvals and knowledge-based solutions. Source and more information
Members’ news
Dow to Add New Independent Directors to Its Board The Dow Chemical Company (NYSE: DOW) announced it will add four new independent directors to its Board: Mr. Richard Davis, Chairman, President and CEO of U.S. Bancorp Mr. Mark Loughridge, former Chief Financial Officer of IBM Mr. Raymond J. Milchovich, Lead Director of Nucor and former Chairman and CEO of Foster Wheeler AG Mr. Robert S. (Steve) Miller, non-executive Chairman of the Board of American International Group (AIG); Former Chief Executive Officer, Hawker Beechcraft, Inc.; Former Executive Chairman, Delphi All four individuals will be included in Dow’s nominations for election at the 2015 Annual Meeting of Shareholders. Source and more information
UFCC ( UNION FRANÇAISE DU COMMERCE CHIMIQUE) informed us that Unipex' CSR commitment was evaluated and awarded Silver level. Read more
BARENTZ COMPLETES ACQUISITION OF AGRINUTRITION TO STRENGTHEN ITS ANIMAL NUTRITION BUSINESS Barentz announces it has completed the full acquisition of AgriNutrition, specialised in the trading and distribution of raw materials and ingredients for the animal feed industry, based in The Netherlands with operations in Europe. This full acquisition follows the joint venture construction Barentz and AgriNutrition have had since 2008. In light of these new developments, Barentz has appointed Paul Verboeket as Vice President to lead its (European) animal nutrition activities. AgriNutrition’s founder and former shareholder Alfred Jansen retired from the business on October 1 st and will remain involved on a consulting basis. Marcel Lagerwaard - commercial director AgriNutrition – will be responsible for all trading activities of the animal nutrition business. Source and more information
BARENTZ CELEBRATES 10 YEAR ANNIVERSARY IN RUSSIA WITH STRONG BUSINESS GROWTH DESPITE ECONOMIC TURMOIL Barentz has been active in Russia since 2004. In its ten years of existence, Barentz has seen a year-on-year double digit growth, resulting is a strong business, serving multinational brands, local leading Russian brands and mid-size local producers. In Russia, Barentz is mainly active in the Food & Nutrition and Personal Care industries. With 80% of its main customers being active in both Personal Care and Food & Nutrition, Barentz has access to a substantial business potential in this high growth, developing market. Most growth opportunities are seen in the Personal Care and Homecare industries. Especially the skin care applications are seeing an increasing demand by consumers, so an increase in local production. The highly technically trained customer teams
Fecc Activities
Fecc members met in Brussels! Membership Meeting 2014 - EU Regulatory Landscape and the impact on the Chemical Industry With over 50 delegates representing more than 30 chemical distributors, manufacturers and national associations, Fecc held its annual membership meeting at the Steigenberger Brussels le Louise on 13 November in Brussels. The participants were welcomed by Fecc’s Director General, Uta Jensen-Korte, to the working committees’ annual update. The chairmen of the committees presented the various achievements our committees accomplished in 2014 and the activities and objectives they have set out for 2014. Fecc’s President, Neville, then opened the General Assembly, with the agenda and previous assembly’s minutes approval. The turn was then for Fecc’s Treasurer, Peter Skou, who presented an update of the 2014 budget, and the forecast for 2015. Based on the recommendation from the Fecc Board the General Assembly at the Membership Meeting approved the budget for 2015. The President then proceeded to present the Fecc Business Plan 2015. Each participant received a copy of the document, which highlights the priorities and key objectives for 2015, and summarises the achievements of the Working Committees in diverse subjects. This year’s theme “EU Regulatory Landscape and the impact on the Chemical Industry” focused on the challenges faced by companies and the impact of the EU regulatory framework on the industry. This meeting gave us an overview of the ongoing initiatives in the regulatory landscape and helped us understand their role in improving the overall quality and coherence of EU legislation affecting the chemical industry. To close this year’s meeting, Fecc hosted an evening reception that offered more networking opportunities to the Fecc members and guests from the European Institutions and representatives from other industry related associations. The networking reception took place at the Wiltchers’ Café at the Steigenberger hotel and featured a tapas style standing dinner that allowed the participants to move around and meet with all guests.
Fecc Activities
Fecc: Moving ahead Building a Sustainable Future Business Plan 2015 The European Association of Chemical Distributors (Fecc), has published its Business Plan for 2014. The document published includes the Working Committees’ achievements for 2014 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. The Fecc Business Plan 2015 was presented at the General Assembly during the Annual Membership Meeting in Brussels on 13 November. The 2015 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 2014, read and download the Business Plan on: www.fecc.org/fecc/publications
Farewell
Message
to
Jan
Thienpont
“We would like to inform you that Jan Thienpont , the Fecc RC and Logistics Manager, has decided to leave Fecc by the end of November. He has received a new very interesting job offer as a Quality Director for the European region with a major packaging manufacturer. This is a great career opportunity for him with new interesting challenges. We would like to congratulate Jan and wish him all the best in his new job. However, we regret that Fecc loses a very experienced and qualified coworker.”
Millchem latest distributor to join Fecc Brussels, November 2014 - The European Association of Chemical Distributors (Fecc), the voice of the European chemical distribution industry, is pleased to announce that Millchem Africa – Southern African leading distributor of industrial chemicals and lubricants has recently joined the association. Fecc is proud to welcome its first African member who has proven over the years to maintain high standards of quality, environmental and safety performance. We constantly strive to further improve membership benefits and increase the number of services offered by our office. Developing our membership is a priority for us; we believe that working together is the way to drive our industry towards success. Read more: http://www.fecc.org/fecc/latest-news
EU Chemicals Legislation
Safety tips: Always keep liquid laundry detergent capsules away from children You might have heard that there have been a number of accidental exposures in young children with liquid laundry detergent capsules in soluble film and that the Commission proposed legislative measures to reduce the associated incident rate : CLP was amended (Regulation(EU) No 1297/2014) to require that the outer packaging [N.B. in this context, ‘outer packaging’ means the box or the pack purchased by the general public and stored in the homes] has · child impeding closures · opaque outer packaging · Precautionary warnings Other requirements were introduced to address the soluble unit dose · minimum mechanical resistance · aversive agent incorporated in the soluble film, associated with a minimum content release time [for us, it is es sential to associate the aversive agent with the content release time: the two measures are related. We expect it to be displayed that way in the legislation. No release time if no aversive agent, it would be meaningless. Also, we do not talk about ‘dissolution’ anymore. What matters is when the film breaks and releases the product. It will be changed in the legislation]. http://eur-lex.europa.eu In addition to legislation, it is important to educate consumers on how to use this new form of products.[this is because acting at the level of the box or the capsule is already too late. Children should never get to see or reach these products] In this context A.I.S.E., the International Association for Soaps, Detergents and Maintenance Products on behalf of the detergent industry, launched an initiative to promote the safe use of liquid laundry detergent capsules in Europe. A video (available in all EU languages) and further educational material is available via the following link: http://www.keepcapsfromkids.eu/be/en A.I.S.E. is currently looking for partners to further disseminate the digital campaign. Liquid laundry detergent capsules are products to help you use just the right amount of detergent for your washing needs they are used daily by millions of consumers. Whilst they are safe when used as intended as outlined on the product package, please store them in a safe place before and after use and always keep them out of reach of children. The companies placing these products on the market take your safety very seriously and guidance on their packs is provided in order to guarantee the safe use of their products for your family
GreenFacts : Understand Risk Assessment, Management and Perception GreenFacts launched an explanatory video on Risk and Hazard.
EU Chemicals Legislation
ENES 7 conclusions and presentations The 7th meeting of the Exchange Network on Exposure Scenarios took place on 18-19 November 2014 in Brussels. Authorities from Member States, NGOs, ECHA representatives industry associations and individual companies were participating. ENES is a cross-sector collaborative network to share knowledge, good practices and approaches to developing, communicating and implementing (REACH) exposure scenarios. Its purpose is to enhance the safe use of chemicals through the supply chain by sharing experience of the lessons learnt in the building and use of exposure scenarios; sharing experience on practical solutions to overcome any obstacles in their development and implementation; improving the understanding on what features make an effective exposure scenario; and enabling chemical product suppliers to move towards adopting suitable approaches that deliver consistent and useful exposure scenarios to downstream users in an efficient way. The discussions focused on the following topics: Main conclusions: •
Progresses are becoming increasingly tangible
•
One goal: safety through the life cycle
• – – – –
Use Maps to connect use and exposure assessment Successful testing of new template confirmed usefulness, e.g. fertilisers supply chain Refreshment on Use Description needed (guidance update) Essential because of connections to exposure assessment All actors will benefit from improved use maps: more realistic assessments, provided registrants embrace it •
– – – – – ty –
IT developments
ESCOM Package: ESCOM 2.0 due Spring 2015 ESCOM Catalogue of Standard Phrases: Further improving Mapping of phrases and XML almost completed New criteria and procedure for phrases submission ESCOM requires ‘marketing’, trust building and a business case: ESCOM saves costs medium-term and improves ES qualiStructured Short Titles: ready for implementation •
Safe use information for mixtures :
– Top-down and bottom-up are complementary but apply to different situations – Top-Down: Cefic/VCI Lead Component Identification Methodology following a logical and scientific step-by-step workflow and allowing (some degree of) automation. It applies to most mixtures, all aspects considered and it is based on CLP classification mixture and substance safe levels (DNELs/PNECs and surrogates) + considerations of ‘special cases’ – ‘Bottom-up’: DUCC ‘approach for end-use mixtures in specific sectors, for workers. – Further work is still needed on both approaches: pls test it and provide feedback •
Connecting occupational practices and REACH CSA: For consistency
–
RMM Packages: Connecting occupational risk management to the REACH chemical safety assessment (CSA) –
– –
Further evaluation needed Workshop in Helsinki: March 2015
BAuA project
EU Chemicals Legislation
•
IT tools
–
IUCLID 6 update to improve exchange with other IT systems, clarity on CSR/ES and hence efficiency in screening. For re
–
Chesar 3 alignment with recent/upcoming developments: e.g. use maps, export in ESCOM XML format, implement
–
Chesar training and promotion planned
lease 1Q2016 (after testing) Structured Short Titles
• – – – – – –
CSA guidance update
Guidance complemented with Practical Guides (exemplification) and Formats/Templates separately ‘Use description’: improve understanding and systematic application of descriptors Exposure Scenario building Exposure Assessment part (Part D): exposure determinants, RMM libraries, contributing scenarios, sector use maps Consumer exposure: reflect SCEDs Environmental exposure: SpERCs and more focus on OC and released The presentations given at ENES 7 on 18-19 November 2014 in Brussels are now published on ECHA website.
http://echa.europa.eu
Registry of Intentions updated It is of paramount importance that industry keep an active eye on the intentions of Members States with regard to: SVHC, CLH and restrictions. Therefore you will find below a summary of the new intentions recently introduced. Restriction New intentions: • methanol (EC number 200-659-6) New withdrawal: • methanol (following the non-conformity of the dossier) SVHC New intentions: • Karanal (EC 413-720-9) • 1,2-benzenedicarboxylic acid, di-C6-10-alkyl esters CLH New intentions: • bis(1-hydroxy-1H-pyridine-2-thionato-O,S)copper (EC 238-984-0) • iprodione (ISO) (EC 253-178-9) • colecalciferol, vitamin D3 (EC 200-673-2) • maleic anhydride (EC 203-571-6) • succinic anhydride (EC 203-570-0) • disodium 4-amino-6-((4-((4-(2,4-diaminophenyl)azo)phenylsulfamoyl)phenyl)azo)-5-hydroxy3-((4-nitrophenyl)azo)naphthalene-2,7-disulfonate (EC 421-880-6) • permethrin (ISO) (EC 258-067-9) • (R)-p-mentha-1,8-diene • 4-tert-butylphenol • Flupyradifurone (ISO); 4-{[(6-chloropyridin-3-yl)methyl](2,2-difluoroethyl)amino}furan-2(5H)- one
EU Chemicals Legislation New submitted proposals: • • • • • • •
Nonadecafluorodecanoic acid (EC 206-400-3) Penthiopyrad (CAS 183675-82-3) medetomidine (CAS 86347-14-0) momfluorothrin (CAS number 1065124-65-3) mixture of 5-chloro-2-methylisothiazol-3(2H)-one and 2-methylisothiazol-3(2H)-one (CAS number 55965-84-9) 4-Chloro-3-methylphenol hexaflumuron (ISO); 1-(3,5-dichloro-4-(1,1,2,2-tetrafluoroethoxy)phenyl)-3-(2,6difluorobenzoyl)urea
CLP 2015 Deadline—Act now, classify and label your chemicals
ECHA has published a video to raise awareness about the importance of the CLP Regulation. From 1 June 2015, the Classification, Labelling and Packaging (CLP) Regulation will be the only legislation to apply to the classification and labelling of both substances and mixtures. CLP requires companies to classify, label and package their hazardous chemicals appropriately before placing them on the market. The video is available in 23 languages together with more information for the general public. Watch the CLP video on ECHA's YouTube channel EUchemicals
ECHA's Board of Appeal publishes its latest decision The subject of case A-005-2013 was how registrations are handled if there is an unresolved data-sharing dispute at the time of registration and by the time of the technical completeness check. The Appellant claimed that ECHA had unlawfully taken a decision granting a claimant in a data-sharing dispute permission to proceed with its registration, and to proceed to the technical completeness check, despite the fact that the registration was incomplete. The Board of Appeal found that ECHA had, in fact, not taken any such decision. The appeal was therefore considered to be inadmissible and was dismissed. Decisions of the BoA
Announcement of a new decision of the Board of Appeal The Board of Appeal (BoA) has published a new decision. The decision in case A-020-2013 concerns the revocation of a registration due to the failure of the registrant to pay the supplementary registration fee. BoA decisions
EU Chemicals Legislation
Reminder to submit substance notifications by 16 December 2014
in
article
(SiA)
ECHA reminds importers and EU producers of articles that the 16 December 2014 is the deadline for submitting the substance in article (SiA) notifications for the following four substances of very high concern (SVHCs) added to the Candidate List on 16 June 2014: cadmium chloride (EC number 233-296-7), sodium peroxometaborate (EC number 231-556-4), sodium perborate; perboric acid, sodium salt (EC number 239-172-9; 234-390-0), and 1,2-benzenedicarboxylic acid, dihexyl ester, branched and linear (EC number 271-093-5). Companies are invited to verify if their articles meet the conditions for the notification obligation under Article 7 of the REACH Regulation. The notification can be submitted either through the substance in article webform or through REACH-IT using IUCLID. The notification is mandatory for all articles containing SVHCs currently included in the Candidate List if the conditions for the notification obligation are met. Candidate List | Notification of SiA | Webform & REACH-IT using IUCLID
Guidance on Biocides Legislation ECHA has updated the Biocides Guidance web pages to reflect the new Biocidal Products Regulation (BPR) guidance structure. The pages include information on the development and status of the guidance documents and links to the published guidance documents, as well as an updated figure of the BPR structure and related pages. In addition, ECHA has published a corrigendum of Part A Information Requirements, dividing the first version of the guidance document into four respective volumes. Guidance on biocides legislation
New Q&As published on exemptions from authorisation requirement The new Q&As clarify how specific uses are exempted from authorisation. These comprise uses in medicinal products, food or feedingstuffs, plant protection products, biocidal products, motor fuels, cosmetic products and food contact materials. They also comprise use as fuels in closed systems, uses in medical devices, in scientific research and development and the case of manufacture of the substances requiring authorisation according to Annex XIV of the REACH Regulation. Questions and Answers on Application for Authorisation
For more information on Chemicals Legislation, please contact: OphĂŠlie Roblot +32 2 679 02 68 oro@fecc.org
GTDP
Next GTDP Committee meeting - 15 January 2015 The next GTDP committee meeting will be held on 15 January 2015 at Fecc, Brussels. If you have any issues or topics that you wish the committee to discuss, please contact - Joel DSilva - jds@fecc.org
Next EXCiPACT™ Training - 17/18 March 2015 Places filling up ! The next 2-day EXCiPACT™ Training Courses in Europe is to be held on 17th and 18th March 2015 in Brussels. The course is ideal for excipient suppliers looking to implement and be certified to EXCiPACT™ GMP and/or GDP Standards. You will learn what auditors will be expected to see and understand their interpretation of the standards.This is the ideal course to identify what the GMP and GDP standards are all about and how they will be audited. Equally excipient users should also benefit from attending, especially those involved in supplier qualification because your excipient suppliers could be offering you EXCiPACT™ Certificates (and audit reports) in future when you ask to audit them. Should you wish to become a registered EXCiPACT™ auditor then this course is mandatory in order for you to be considered for that registration. For Programme and registration see - http://www.excipact.org/events/1033/
Delegated Regulation on GMP - good manufacturing practice for API - active pharmaceutical ingredient The European Commission has published the delegated regulation (EU) No 1252/2014 of supplementing Directive 2001/83/EC of the European Parliament and of the Council with regard to principles and guidelines of good manufacturing practice for active substances for medicinal products for human use. Available via the European Commission website - http://ec.europa.eu/health/files/eudralex/vol-1/reg_2014_1252/reg_2014_1252_en.pdf
EMA: Guideline on Biosimilars 2014 A biosimilar is a biological medicinal product that contains a version of the active substance of an already authorised original biological medicinal product (reference medicinal product) in the EEA. The EMA has published a revised version of the guideline "Guideline on similar biological medicinal products". Source: GMP Publishing - http://www.gmp-publishing.com/en/gmp-news/gmp-aktuell/ema-guideline-biosimilars-principles2014.html
For more information on International Trade, please contact : Joel D’Silva +32(0)2 679 02 62—jds@fecc.org
GTDP
Oceania Regulator ANZTPA Shut Down by Australia and New Zealand Australian and New Zealand officials have confirmed they plan to stop development of the Australia New Zealand Therapeutics Products Agency (ANZTPA), a joint regulatory authority meant to more efficiently regulate healthcare products in both countries. Despite recently completing its first harmonization activity, Australian and New Zealand officials have now decided to end the ANZTPA effort, saying a "comprehensive review of progress and [an] assessment of the costs and benefits to each country" had concluded the effort was no longer worth pursuing.
See more at RAPS:
CFDA proposes revision of 25 year old cosmetics regulation In an effort to regulate and strengthen the supervision and management of cosmetics, the China Food and Drug Administration (CFDA) is set to revise cosmetic health supervision regulations.
Source: cosmetics design-Asia
Russia publishes cosmetics ingredients textbook Russia has published a new edition of the 'Encyclopedia of ingredients for cosmetics and perfumery'. Source: cosmetics design-Europe
Lanolines Stella site receives EXCiPACT™ certification as pharmaceutical excipient suppliers EXCiPACT asbl is delighted to announce that Lanolines Stella sa has recently received an EXCiPACT™ Certificate from SGS France, one of EXCIPACT’s internationally-recognised Certification Bodies. The Certificate demonstrates that the Lanolines Stella site at Mouscron, Belgium, manufactures pharmaceutical excipients according to the EXCiPACT Good Manufacturing Practice (GMP) Certification Standard. The Belgian site is the second Belgian site to receive Certification and it is the 15th site to be Certified globally to date. The others sites are in Canada, Germany, The Netherlands, Saudi Arabia, Spain and the UK - For more info see
http://www.excipact.org/certification/certificates/
International Trade
International Trade Committee meeting 13 November 2014 - Brussels The Fecc International Trade Committee meeting was held in Brussels on 13 November 2014. The morning session included presentations on trade negotions and embargoes/sanctions by Mr. Harald Past (Eurocommerce) and Joel DSilva (Fecc). The afternoon session included a presentation and Q&A session on Distribution agreements and competition Law by Mr. Craig Simpson and Mr. Jean-Nicolas Maillard from the Law firm - Steptoe & Johnson LLP. Presentations are available to Fecc members via the Fecc website.
Chemicals in TTIP - new ideas for working together In May 2014 the European Commission published the EU's initial position on chemicals. Now 2 more papers have been published: (a) A draft outline for provisions on chemicals in TTIP and (b) How to put ideas for cooperation under TTIP into practice – a few examples The papers set out ideas for how EU and US regulators could work together in future on things like testing, classifying and labelling chemical products. Source: DG Trade - http://trade.ec.europa.eu/doclib/press/index.cfm?id=1204
EU & Other News
EU Annual Growth Survey 2015: A new Momentum for Jobs, Growth and Investment The 2015 Annual Growth Survey (AGS) published by the European Commission today focuses on putting Europe firmly back on a path of sustainable job creation and economic growth. The arrival of the new Commission, with an ambitious agenda for Jobs, Growth, Fairness and Democratic Change, is the right moment to generate a new momentum. By proposing an ambitious Investment Plan to mobilise at least € 315 billion of additional public and private investment over the next three years, Europe is turning a page (Investment Plan press material). This is part of the European Commission's overall approach to support job creation and get Europe growing. As part of this approach, the Commission, in its Annual Growth Survey 2015, recommends pursuing an economic and social policy based on three main pillars: (1) a boost to investment, (2) a renewed commitment to structural reforms and (3) the pursuit of fiscal responsibility.
For source and information : http://europa.eu/rapid/press-release_IP-14-2235_en.htm
For more information on International Trade, please contact : Joel D’Silva +32(0)2 679 02 62—jds@fecc.org
Calendar Date 2015 January 15 February 17 March 12 17-18 20 April
Meeting
Location
GTDP Committee
Brussels
SHE Committee
Brussels
BOARD Meeting EXCiPACT Training Responsible Care
Brussels Brussels Brussels
23 May 5 6-8 June 10 July 29 September 8 23
ESAD Steering Committee
Cefic, Brussels
BOARD Meeting Annual Congress
Athens Athens
Responsible Care
Brussels
SHE Committee
Brussels
Responsible Care BOARD Meeting
Brussels Hamburg
29 October 21 November 25 December 3
ESAD Steering Committee
Fecc, Brussels
SHE Committee
Brussels
BOARD Meeting
Brussels
Responsible Care
Brussels
Contact us! Fecc secretariat +32 2 679 02 60 • Uta Jensen-Korte, Director General ujk@fecc.org • Alexandra Mengesha, Communications Manager ame@fecc.org • Joel D’Silva, Life Science & International Trade Manager jds@fecc.org • Ophélie Roblot, Health Safety & Environment Manager oro@fecc.org • Sarah Anhorn, Office Manager san@fecc.org
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Chief editor: Alexandra Mengesha - Communications Manager +32 2 679 02 63, ame@fecc.org Editorial staff: Fecc Policy Managers Pictures: Shutterstock, PSD Graphics, member companies and private pictures
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