Issue 7- November 2014
Inside this issue Members’ news Fecc Activities EU Chemicals Legislation GTDP International Trade
2 7 8 12 15
EU & Other News Calendar 17
16
Members’ news
Solvay CEO Jean-Pierre Clamadieu was on October 17 elected President of Cefic In his first address as Cefic President, Mr Clamadieu outlined his goals for the next two years during the chemical trade body's annual meeting in Paris. He stressed it was vital for Europe's 29,000 chemical companies and their 1.2 million employees to stay competitive. Overall investment in European chemical production is falling and some European industrial value chains are at risk. Mr. Clamadieu intends to focus especially on competitiveness and innovation. Read More
Brenntag joins UN Global Compact UN Global Compact, a voluntary initiative set up to promote sustainable development and social responsibility. As well as being the first chemical distributor to join the UN Global Compact, Brenntag uses this step to further expand its sustainability strategy at the same time. Steven Holland, CEO of the Brenntag Group: “Safety, responsibility and sustainability are central factors in Brenntag’s daily practice. This being the case, it is a logical step for us to join the UN Global Compact and to incorporate the initiative’s ten principles as a fixed part of our company strategy and everyday work.” The United Nations Global Compact is a strategic initiative for companies that undertake to align their business activities and strategies with ten universally recognized principles in the areas of human rights, labor standards, environmental protection and the fight against corruption. With more than 12,000 participants from over 145 coun-
Biesterfeld AG and HANNOVER Finanz Group become partners Biesterfeld AG, Hamburg, continues its sustainable and long-term growth strategy with its partner HANNOVER Finanz Group, Hannover, who takes a minority participation in the plastics and chemical distributor. Biesterfeld Vermögensverwaltung GmbH & Co. KG, currently holding 100% of the shares in Biesterfeld AG, and HANNOVER Finanz Group, Hannover, agreed on the acquisition of 28.6% of the shares of Biesterfeld AG by the latter. This agreement still awaits approval by the German Federal Cartel Authority. The HANNOVER Finanz Group has been a silent partner in Biesterfeld Vermögensverwaltung GmbH & Co. KG since January 2011. This silent partnership is, as envisaged, now converted into a minority shareholding interest in Biesterfeld AG. The Board of Biesterfeld AG welcomes this step, which allows further growth of the group and sustainably strengthens the equity position of Biesterfeld AG through a capital increase by the HANNOVER Finanz
Group. "With HANNOVER Finanz Group we have a partner who has vast experience in the development of medium-sized enterprises. This step ensures the further development and growth of our Group as a familyowned medium-sized company”, says Birger Kuck, CEO of Biesterfeld AG. "Biesterfeld AG is on a successful growth path and as financial investors we will accompany this family owned enterprise with a minority partnership” adds Jürgen v. Wendorff, Member of the Board of the HANNOVER Finanz Group. “The HANNOVER Finanz Group supports companies with long-term financing of equity-capital. Other family owned companies, like Rossmann, Fielmann and Hirschvogel, equally financed their growth strategy with the HANNOVER Finanz Group as partners.” Source and more information
Members’ news
Caldic expands production capabilities and services Acquisition of RoRe Technologies adds complementary production capabilities and access to expertise in widely qualified silicone preparations and strengthens Caldic’s own silicone brand Calsil®.
Calsil® private label, leveraging rock-solid expertise in specialty chemicals, food ingredients and cosmetics.
“This acquisition crowns a rich collaboration with RoRe Technologies delivering a myriad of high-end foodprocessing and personal care solutions. From world-class Caldic, distributor and producer of chemicals and food Kosher-grade preparations, to bespoke emulsions & disingredients in Europe, Asia and North America simplifies persions, this silicone expertise turns into tailored soluthe silicone industry by acquiring RoRe Technologies eartions to fuel our geographic expansion” says Philippe ly July 2014. Relocated to the Caldic plant in Lyon, this Rovere, Silicone Division and Calsil® Brand Manager. acquisition emphasizes Caldic’s ambition to strengthen its position as a leading full service distributor providing With this strategic acquisition, Calsil® demonstrates yet innovative products, value added services and total soluagain the pertinence of “Simplifying Silicone Solutions”, tions. offering an inspiring and competitive alternative in silicone sourcing. Acquiring this factory will contribute substantially to the Source and more information company’s production capacity, added value and solution development capabilities. Caldic strengthens its Calsil® silicone brand with RoRe Technologies’ long expertise in widely qualified silicone preparations, serving demanding food-processing and cosmetics regulated markets. RoRe Technologies finds a leading worldwide distributor to offer simple silicone solutions under its
VELOX presenting its product range at Advanced Engineering UK VELOX will be exhibiting at Advanced Engineering UK taking place at NEC in Birmingham (UK) on the 11th and 12th November 2014. Hosted as part of the Advanced Engineering UK 2014 group of events, the Composites Engineering Show is the UK’s only dedicated Composite materials, design and processing event. The show hosts more than 200 ‘compositesrelated’ specialist exhibitors. VELOX will be delighted to welcome you at Hall 5 Booth C151, where its team will present you the highlights from the company’s extensive range of composites specialities. The large portfolio includes epoxy resins, reinforcements such as natural fibres, pre-pregs, carbon fibre, as well as tooling materials, core materials, release agents. VELOX is proud to host two of their suppliers, at its booth this year: Sika, a global leader in construction-industry chemicals with its wide range of bonding, adhesive, sealing, reinforcing and protection products as well as Wolfangel, the world known family enterprise producing ranges of the whole FRP equipment from small gelcoaters, chopper, plc controlled injection and metering systems to high end customized machines for various applications. Source and more information
Members’ news
Changes in the Board of Executive Directors of BASF The Supervisory Board of BASF SE appointed Sanjeev Gandhi (47) to the Board of Executive Directors effective December 1, 2014. He has been head of BASF’s Intermediates division since 2010. After 12 successful years on the Board of Executive Directors, Dr. Andreas Kreimeyer (59) will retire with the expiration of his contract following the Annual Shareholders’ Meeting on April 30, 2015. He has been on the Board since 2003 and Research Executive Director since 2012. Dr. Martin Brudermüller (53), Vice Chairman of the Board of Executive Directors, will take over this role following the Annual Shareholders’ Meeting. Following these changes, the Board of Executive Directors has decided to redistribute its responsibilities effective May 1, 2015: Source and more information
BASF inaugurates chemical complex in Dahej, India BASF India Limited (BSE code: 500042) today inaugurated its large-scale chemical production complex at Dahej in Gujarat, India. With a project cost of INR 1,000 crore (approximately €150 million), the site represents BASF’s single largest investment in India. The site was jointly inaugurated by Smt. Anandiben Patel, Hon’ble Chief Minister of Gujarat; Shri Saurabhbhai Patel, Hon’ble Minister for Finance, Energy and Petrochemicals, Government of Gujarat and Mr. Michael Heinz, Member of the Board of Executive Directors, BASF SE. Source and more information
DKSH extends relationship with Roche across Asia DKSH Business Unit Healthcare, a leading partner for healthcare companies seeking to grow their business in Asia, will continue to provide Market Expansion Services for Roche’s full pharmaceutical product portfolio in Cambodia, Hong Kong, Laos, Malaysia, Myanmar, Singapore, Thailand and Vietnam. DKSH is managing Roche’s entire supply chain operations for pharmaceutical products and distribution to hospitals, clinics and pharmacies in the region. It is the first time that DKSH and Roche work together in Singapore. In the other Asian markets, the agreement is a long-term extension of existing relationships that date back to as long as the 1940s. “The extension of our agreement into new markets provides opportunities for Roche. DKSH is a reliable and professional partner that helps us grow our business across Asia, so that we can focus on our core business,” said Philippe Meyer, General Manager, Roche Thailand Limited. DKSH and Roche enjoy a long and successful
collaboration. We are committed to utilize our in-depth healthcare expertise and network of unique scope and depth for growing Roche’s business in new and existing markets,” said Thomas Delemazure, Regional Business Development Director, DKSH Healthcare. The agreement will further strengthen DKSH’s market position in the region while contributing incrementally to the Group’s overall profitability over time. Source and more information
Members’ news
Univar Announces Exclusive Distribution Agreement for Evonik Personal Care Products in the Northeast U.S. Univar Inc., a leading global chemical distributor of industrial and specialty chemicals and related chemistry services, announced that it has reached an agreement with Evonik Corporation to become the exclusive distributor for Evonik personal care products in the Northeastern United States. Evonik will continue to sell their silicone-based products directly. Evonik, a world leader in specialty chemicals, specializes in ingredients and concepts for effective skin, hair, and body care products. The Evonik personal care portfolio consists of a unique and comprehensive range of organic and silicone-based specialties designed as raw materials for personal care products and active ingredients for the protection of skin and hair. This agreement strengthens the successful relationship between Univar and Evonik, and leverages t the combined strength of Univar’s distribution service and Evonik’s product portfolio. Source and more information
AkzoNobel EGM appoints Maëlys Castella as member of the Board of Management Shareholders of Akzo Nobel N.V. held an Extraordinary General Meeting in Amsterdam and appointed new CFO Maëlys Castella as a member of the Board of Management. Maëlys is already a member of the company's Executive Committee as Chief Financial Officer since September 15 and is based at AkzoNobel's head office in Amsterdam. She succeeded Keith Nichols who left the company in June this year. "Maëlys is a high caliber professional with a wealth of experience in finance who brings key skills and capabilities to our company," said Antony Burgmans, Chairman of AkzoNobel's Supervisory Board. A French national, Maëlys previously worked at Air Liquide for 14 years, most recently as Group Deputy CFO. Her previous posts there include Europe Chief Financial Officer and Group Corporate Finance and Treasury Director. She started her career at the international ELF Oil & Gas Group. Source and more information
IMCD and BASF extend acrylic monomer partnership to Iberia IMCD has partnered with BASF for the distribution of its acrylic monomers for more than 35 years, continuously expanding the cooperation to different regions during this time. Representing the last remaining IMCD European territory to be included in the partnership agreement, this expansion will allow IMCD to distribute glacial acrylic acid, methacrylic acid, 2-ethylhexyl acrylate, butylacrylate, ethylacrylate and methylacrylate in Iberia. These monomers are key raw materials in industrial synthesis and are used within a broad range of end applications including synthetic resins for coatings, paints, textiles, detergents, paper and construction. Source and more information
Members’ news
Dow Corning receives Henkel Supplier Sustainability Award Dow Corning – a global leader in silicones, silicon-based technology and innovation – has been awarded the "Supplier Sustainability Award" by Henkel Adhesive Technologies this year, for its ongoing efforts to optimize its sustainability processes. This "Outstanding Partner" award is one of three awards that recognize outstanding performance by Henkel's partners and suppliers in the fields of sustainability, supply and innovation.
certain sustainability aspects with Henkel, collaborating with Henkel to develop new concepts to meet specific customer needs.
"Incorporating sustainability into our business strategy is essential in today's business environment, and is one of Dow Corning's core values. It's also the foundation of our future success," explained Jeroen Bloemhard, Executive Sponsor for Henkel. "Global companies today select busiThe award reflects how Dow Corning played a key role in ness partners based on a common vision and goals. integrating sustainability throughout Henkel's entire val- Dow Corning's sustainability concepts in terms of materiue chain, helping the company get closer to the targets al supply, energy reduction and waste control directly align with Henkel's sustainability goals." set out in its sustainability strategy. Source and more information Through a proactive approach, Dow Corning tackled
WACKER Receives Bavarian Energy Award for Highly Efficient Polysilicon Production Wacker Chemie AG was honored with a Bavarian Energy Award by Bavaria’s state government. At a ceremony last night in Nuremberg, one of the two major awards went to the Munich-based company for its highly efficient polysilicon production. With advanced, patented technology and process optimization, WACKER achieved a 29percent drop in specific energy consumption for polysilicon production. Hyperpure polysilicon is the main raw material for making solar modules and, consequently, plays a vital role in generating solar power. The Bavarian Energy Award is conferred every two years for outstanding innovations in responsible energy management. Souce and more information
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 1st 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
Fecc Activities Fecc Membership Meeting 2014
EU Regulatory Landscape and the impact on the Chemical Industry NOVEMBER 12, 2014
We are pleased to invite you to the 2014 Fecc Membership Meeting and Evening Reception to celebrate Fecc’s 60th Anniversary at the Steigenberger Grandhotel in Brussels on November 12, 2014. This year’s afternoon session and the evening speech will focus on the challenges faced by companies and the impact of the EU regulatory framework on the industry. This meeting will give us an overview of the ongoing initiatives in the regulatory landscape and help us understand their role in improving the overall quality and coherence of EU legislation affecting the chemical industry. PROGRAMME
International Trade Committee meeting 13 November 2014 - Brussels The next International Trade Committee meeting will be held in Brussels on 13 November 2014 from 10.00 – 15 hrs at the Interel meeting room, Rue du Luxembourg 22-24, Brussels 1000. The agenda includes a presentation and Q&A session on Distribution agreements and competition Law which will be made by Mr. Craig Simpson, Senior European Legal Advisor at the Law firm - Steptoe & Johnson LLP. Please click here for draft agenda If you are interested in attending please contact Joel DSilva – jds@fecc.org
EU Chemicals Legislation
ChemAgora (http://chemagora.jrc.ec.europa.eu), a new chemical information portal launched by the European Commission's Joint Research Centre, will make life easier for everybody who is looking for information available online on a certain chemical substance. Chemicals can be searched by their name, (also partial), CAS Registry number, InChIKey or chemical structure (by drawing the molecule in an appropriate editor). Once either of these search criteria is entered, the JRC service searches through a series of public repositories (currently twelve) and offers clickable links to the exact pages where more information about the chemical can be found. The tool also provides a list of synonyms the chemical is known under. People in need of a comprehensive overview of what information is available about a certain chemical will find there a useful tool.
Clarity on interface between REACH and the Cosmetics Regulation Substances used in cosmetic products may need to be registered under REACH but, under certain circumstances registrants may not have to carry out new tests on animals. Answers to questions on the interface between REACH and the Cosmetics Regulation are available on ECHA's website. To meet the requirements of the new Cosmetics Regulation (Regulation (EC) No 1223/2009) cosmetic products are prohibited to be placed on the market where the final formulation, ingredients in a final formulation or a finished product, have been subject to animal testing. Those same chemical ingredients may, however, also need to be registered under REACH. This has created some uncertainty about whether testing on animals can take place in order to comply with REACH, or whether it should not, in order to comply with the Cosmetics Regulation. The European Commission, in cooperation with ECHA, has now clarified the relationship between the marketing ban and the REACH information requirements as follows:
Registrants of substances that are exclusively used in cosmetics may not perform animal testing to meet the information requirements of the REACH human health endpoints, with the exception of tests that are done to assess the risks to workers exposed to the substance. Workers in this context, refers to those involved in the production or handling of chemicals on an industrial site, not professional users using cosmetic products as part of their business (e.g. hairdressers).
Registrants of substances that are used for a number of purposes, and not solely in cosmetics, are permitted to perform animal testing, as a last resort, for all human health endpoints.
Registrants are permitted to perform animal testing, as a last resort, for all environmental endpoints.
Therefore, the testing and marketing bans in the Cosmetics Regulation do not apply to testing required for environmental endpoints, exposure of workers and non-cosmetic uses of substances under REACH. Registrants of substances registered exclusively for cosmetic use will still have to provide the required information under REACH wherever possible, by using alternatives to animal testing (such as computer modelling, read-across, weight of evidence etc.). For more information: Questions & Answers Factsheet [PDF]
EU Chemicals Legislation
2nd Joint Workshop/Training "How to classify Mixtures under CLP" - 22-23 January 2015 – Cefic – Brussels
Following the success of the first Workshop held in May 2014, we are pleased to send you the programme and registration details for the secondCefic/Eurometaux/Fecc/DUCC Workshop “How to classify MIXTURES under CLP” Be able to check your software results! 22-23 January 2015 – Cefic (Brussels) The intention of the workshop is to enable you to check the classification results of the software you are using. The focus of the workshop will therefore be on practical examples and exercises. Who should attend? CLP managers from companies and associations who have to deal with the re-classification of mixtures. You all know that CLP requires the classification of mixtures based on CLP by the 1 June 2015. So not too much time is left! Practical details Participation is limited to around 40 participants. Seats will be available on a first come, first served basis. DATE: 22 January 2015 from 10:30 to 17:30 hrs and 23 January 2015 from 9:00 to 16:45 hrs PLACE: Cefic – Avenue E van Nieuwenhuyse 4 – 1160 Brussels For more information and to register: click here
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. CLH New intentions: 2,3-epoxypropyl methacrylate (EC No. 203-441-9, CAS No. 106-91-2). New submitted proposals: Mixture of 5-chloro-2-methylisothiazol-3(2H)-one and 2-methylisothiazol-3(2H)-one Momfluorothrin (S-1563)*; 2,3,5,6-Tetrafluoro-4-(methoxymethyl)benzyl (Z)-(1R,3R)-3-(2-cyanoprop-1-enyl)-2,2dimethylcyclopropanecarboxylate *CAS number 609346-29-4
EU Chemicals Legislation
Forum Multi-annual Work programme 2014-2018 The Forum for Exchange of Information on Enforcement (Forum) has published the Multi-annual Work Programme 2014-2018. According to this document future REACH Enforcement (REF) Projects will also focus on: - General duties, such as dossier compliance (including substance sameness and opt-out dossiers) and testing proposal compliance - SDS duties (content, extended SDSs/exposure scenarios, language) - CLP duties (inventory, notification (in particular following harmonised classification), general CLP inspections) - ECHA decisions - Authorisations - Restrictions The Forum wants to strengthen the cooperation and information exchange between networks covering enforcement of chemicals or related legislation like protection of human health and safety and the environment to promote the safe use of chemicals across the whole of Europe. Cooperation with customs will also continue. The Forum activities will also include: - European training programmes for inspectors (to ensure comparable inspections and results) - Development of guides for inspectors - exchange of inspectors between Member States (to contribute to a more harmonised approach for the enforcement of REACH and CLP) Please find here the complete report: http://echa.europa.eu/documents/10162/13608/ final_mb_38_2013_mawp_2014-2018_en.pdf
The Biocidal Products Committee adopts 10 opinions The Biocidal Products Committee (BPC) met for the 7th time from 30 September to 3 October 2014. The adopted opinions concern, and support the approval of the following active substances and their product-types (PTs): glutaraldehyde for PTs 2, 3, 4, 6, 11 and 12, clothianidin for PT 18, MIT for PT 13, MBM for PTs 6 and 13.
For more information on Chemicals Legislation, please contact: OphĂŠlie Roblot +32 2 679 02 68 oro@fecc.org
EU Chemicals Legislation
Commission consults the public on criteria to identify Endocrine Disruptors The European Commission has launched an online consultation to help define criteria for endocrine disruptors as required by the regulations on biocidal and plant protection products. All citizens and organisations are invited to contribute to the consultation which will be open until 16 January 2015. Replies to the public consultation will, subject to confidentiality rules, be published following the closure of the consultation. Link to the consultation: http://ec.europa.eu/dgs/health_consumer/dgs_consultations/food/consultation_20150116_endocrinedisruptors_en.htm
New formulators web pages launched The new pages direct formulators to relevant and useful information on the ECHA website to help them to fulfil their obligations under REACH and CLP. The web pages also provide new information, such as communicating information from exposure scenarios further downstream. Find out about mixture classification, when you need to communicate with your suppliers, and what you can expect to receive from your suppliers, and what and how you need to communicate further down the supply chain to your customers. Translated pages will follow in due time. Formulators pages
REACH 2018 web pages unveiled ECHA urges all companies to start preparing now for the REACH registration deadline of 31 May 2018. To support this, ECHA has published new web pages with improved access to relevant information. This registration deadline concerns substances manufactured or imported in low volumes, 1 to 100 tonnes per year. REACH 2018 pages : http://www.echa.europa.eu/web/guest/reach-2018
Directors' Contact Group documents now available The Directors' Contact Group has published a communiquĂŠ and two documents. The documents give recommendations on sound SIEF management and emphasise the importance of having a fair, transparent and non-discriminatory cost sharing system in SIEFs. DCG web page | Cost sharing systems in SIEFs | Sound SIEF management | CommuniquĂŠ
GTDP
EXCiPACTTM Training course - 18-19 November 2014 – The 2-day EXCiPACT™ Training Courses in Europe to be held on 18th and 19thNovember 2014 at Fecc in Brussels is fully booked. For more information and dates of the next training course in 2015 see – www.excipact.org or contact EXCiPACT Secretariat - training@excipact.org
European Eudralex V29 is now available You can now consult the whole Pharmaceutical Legislation (Human and Veterinary) with an integrated search engine. The Eudralex V29 is similar to the EudraLex currently available, but it can be used off-line with the search engine. All the documents are in.pdf format and without protection. For a non-commercial use, Eudralex V29 may be duplicated, shared and the documents may be printed. Eudralex V29 is available via the European Commission website - http://ec.europa.eu/health/documents/eudralex/cd/index_en.htm
UK MHRA: GMP Inspection Deficiencies 2013 The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published inspection trend data from 2013. In addition to 2013 inspection deficiency data, the report also includes n ‘top 10 deficiencies’ and highlights areas for continued focus. The most frequently encountered defect categories raised over the previous five years have remained relatively consistent with the exception of ‘contamination, chemical/physical (or potential for)’ which has significantly increased. Deficiencies relating to ‘quality systems’ are by far the most prevalent observed during inspections. Source: GMP Publishing - http://www.gmp-publishing.com/en/gmp-news/gmp-aktuell/mhra-review-deficiencies2013.html
EMA: Reflection Paper on API Starting Materials The European Medicines Agency (EMA) has released a “Reflection paper in the requirements for selection and justification of starting materials for the manufacture of chemical active substances”. It aims to clarify some of the expectations of EU competent authorities arising from the guidance found in ICH Q11 regarding the information to be submitted in marketing authorisation dossiers to justify the selection of starting materials. Source: GMP Publishing - http://www.gmp-publishing.com/en/gmp-news/gmp-aktuell/ema-reflection-paper-apistarting-materials.html
US FDA: Guidance for Industry on Drug Inspection The US Food and Drug Administration (FDA) has released the final version of its Guidance for Industry entitled “Circumstances that constitute delaying, limiting, or refusing a drug inspection”. Delaying, refusing, denying – FDA inspectors often see themselves confronted with cooperation problems. The guidance intends to clarify how the law under Section 707 of FDASIA (Food and Drug Administration Safety and Innovation Act) will be interpreted and put into practice by the FDA. Source: GMP Publishing - http://www.gmp-publishing.com/en/gmp-news/gmp-aktuell/fda-guidance-druginspection.html
GTDP
India bans import of animal tested cosmetics India has become the first cruelty-free cosmetics zone in South Asia having banned the import of animal tested cosmetics, only months after the implementation of a national ban on cosmetics testing in India’s labs. The ban comes into place on November 13, 2014.Source: Cosmetics-design - http://www.cosmeticsdesign-asia.com/RegulationSafety/India-bans-import-of-animal-tested-cosmetics
European Commission rules concentration of 10% for UV filter in sunscreens The European Commission Scientific Committee for Consumer Safety (SCCS) has ruled UV filter 1,1'-(1,4piperazinediyl)bis[1-[2-[4-(diethylamino)-2-hydroxybenzoyl]phenyl]-methanone (HAA299), safe at a concentration of up to 10% in sunscreen products. Source: Cosmetics-design - http://www.cosmeticsdesign-europe.com/Regulation-Safety/SCCS-rules-concentrationof-10-for-UV-filter-in-sunscreens
European Commission adopts measures on three preservatives in cosmetic products The European Commission has adopted two measures restricting the use of three preservatives in cosmetic products. The Commission decision follows an assessment by the independent Scientific Committee on Consumer Safety (SCCS), an advisory body which carried out a careful risk assessment of the substances before recommending their restriction or ban. With the adopted measures the Commission limits the maximum concentration of two preservatives, Propylparaben and Butylparaben, from currently allowed limit of 0.4% when used individually and 0.8% when mixed with other esters, to 0.14%, when used individually or together. They are being banned from leaveon products designed for the nappy area of young children below the age of three since existing skin irritation and occlusion may allow increased penetration than intact skin. The new rules will apply for products put on shelves after 16 April 2015. Secondly, the Commission bans the mixture of Methylchloroisothiazolinone (and) Methylisothiazolinone (MCI/MI) from leave-on products such as body creams. The measure is aimed at reducing the risk from
and the incidence of skin allergies. The preservative can still be used in rinse-off products such as shampoos and shower gels at a maximum concentration of 0.0015 % of a mixture in the ratio 3:1 of MCI/MI. The measure will apply for products placed on the market after 16 July 2015. Earlier this year, the Commission banned the use of five other parabens in cosmetic products - Isopropylparaben, Isobutylparaben, Phenylparaben, Benzylparaben and Pentylparaben (See Commission Regulation (EU) No 358/2014) due to the lack of data necessary for reassessment. Products placed on the market after 30 October 2014 will have to be free from these substances. Source: European Commission - http://europa.eu/rapid/ press-release_IP-14-1051_en.htm
GTDP
Court of Justice of the European Union (ECJ) Judgment on Acino AG v COM: Competent authorities may suspend marketing authorizations or withdraw products from the market in case of serious GMP failures [[2014] All ER (D) 133 (Apr)] Background Following an inspection which revealed serious quality problems (GMP non-compliance) of a third-country API manufacturer for the company Acino AG (A), the Commission took measures to prevent any product that contained active substances produced in that factory from being placed on the EU market. In addition, the relevant marketing authorisations were modified (in the framework of an ‘Article 20’ referral) by deleting the factory from the list of authorised manufacturing sites. The company considered these measures as being disproportionate; arguing that despite the quality problems in the factory, subsequent tests of the manufactured batches had shown that those problems did not affect the finished products. A. started therefore in 2010 an action before the General Court (first instance). In 2013 the General Court confirmed the position of the Commission. In July 2013 A. appealed against this decision before the Court of Justice of the European Union (ECJ). With its ruling of April, the Court dismissed the appeal.
Main considerations of the Court The concerned Commission decisions were based on the conclusion that due to the GMP non-compliance it could no longer be considered that the "qualitative and quantitative composition" of the finished products was as declared. Such a deviation is one of the grounds allowing the Commission to vary, withdraw or suspend a marketing authorisation for a centrally authorised product or to withdraw the product form the market (Article 116/117 of Directive 2001/83). While the Commission (based on the scientific opinion from EMA) has the burden of proof for such conclusion, the Court confirmed that the Commission is entitled to act on the basis of considerations which are "based on solid and persuasive evidence to entertain reasonable doubts as to the declared qualitative and quantitative composition of the medicinal product at issue" (para. 61). In view of the precautionary principle the Commission may act based on a potential risk. Non-compliance with GMP may constitute such a potential risk of impairment of the qualitative composition and, therefore, of detriment to public health (para. 72). It was consequently justified to take action in the present case. With its ruling the Court of Justice of the European Union confirmed that competent authorities may suspend marketing authorisations or withdraw products from the market in case of serious GMP failures in a manufacturing site.
For more information on International Trade, please contact : Joel D’Silva +32(0)2 679 02 62—jds@fecc.org
International Trade
EU requests WTO consultations with Russia over excessive import duties The EU has requested consultations with Russia in respect of import duties for paper products, refrigerators and palm oil. The EU takes this first step in the dispute settlement procedure in response to the violation by Russia of its obligations under the World Trade Organisation (WTO). Upon joining the WTO, Russia committed to keep its import duties below the limits expressed in the accession documents. However, it has continued taxing a number of products across various sectors more heavily than agreed. This is still the case today for certain products of interest for the EU. Source: DG Trade - http://trade.ec.europa.eu/doclib/press/index.cfm?id=1187
EU-Japan FTA talks advance further The EU and Japan have finished another week of negotiations aiming at concluding an ambitious free trade agreement. The EU and Japan made further efforts to advance the talks in almost all the areasunder negotiation: tariffs, technical barriers to trade, access to public tenders, trade in services, rules on investment competition, sanitary and phytosanitary measures, regulatory cooperation, transparency and protection of intellectual property, including geographical indications. Rules of origin, as well as trade facilitation and customs will be discussed during the period between the formal negotiating sessions. The EU wants the negotiations with Japan to address a number of concerns affecting EU business with Japan, among others non-tariff barriers and unsatisfactory access to the Japanese public procurement market. If this is achieved, EU exports to Japan could increase by over 30%. Source: DG Trade - http://trade.ec.europa.eu/doclib/press/index.cfm?id=1168
European Commission updates EU control list on dual use items The European Commission has updated the EU list of dual-use items – goods, software and technology normally used for civilian purposes but which might have military applications or contribute to the proliferation of weapons of mass destruction. The updated list takes into consideration the latest commercial and technological developments and thus provides transparency and upholds the competitiveness of EU exporters. The updated list also reflects growing security concerns regarding the use of surveillance technology and cybertools that could be misused in violation of human rights or against the EU's security: controls are introduced on new categories of items such as IT intrusion software ('spyware') and telecommunication and internet surveillance equipment. Source: DG Trade - http://trade.ec.europa.eu/doclib/press/index.cfm?id=1166
For more information on International Trade, plese contact : Joel D’Silva +32(0)2 679 02 62—jds@fecc.org
International Trade
EU and Singapore conclude investment talks The European Union (EU) and Singapore have concluded the negotiations of the investment part of the EUSingapore Free Trade Agreement (EUSFTA). This marks the successful conclusion of the negotiations of the entire EUSFTA, following the initialling of the other parts of the agreement in September 2013. The Investment Protection Chapter in the EUSFTA will strengthen investment relations between the EU and Singapore. The chapter commits both the EU and Singapore to ensuring a stable and fair regime for foreign investors while preserving the right of the parties to regulate in the public’s interest.
EU makes trade deal with East African Community Negotiators from the EU and the East African Community (EAC) have finalised a new comprehensive Economic Partnership Agreement (EPA) between both regions. The agreement will provide legal certainty for businesses and open a long-term perspective for free and unlimited access to the EU market for products from Burundi, Kenya, Rwanda, Tanzania and Uganda. Beyond the elimination of customs duties, the agreement covers important issues, such as free movement of goods, cooperation on customs and taxation, and trade defence instruments, which mirror the effort of the EAC to strengthen its customs union and to set up an effective internal market. Source: DG Trade - http://trade.ec.europa.eu/doclib/press/index.cfm?id=1163
EU & Other News
Council calls for a 'greener' Europe 2020 strategy Meeting in Luxembourg on 28 October, environment ministers adopted conclusions on 'greening' the European Semester and the Europe 2020 strategy. The conclusions recognise that a greener economy contributes to long term prosperity, and highlight the need for a transition towards a resource efficient circular economy. In particular, they underline the need for:
better integrating resource efficiency in the Europe 2020 strategy, through the introduction of a nonbinding aspirational target taking into consideration circular economy principles and the potential for green employment in the European Semester conducting a more structured and regular reporting on green skills, employment and growth as part of the joint employment report annexed to the annual growth survey further developing the definition of green jobs, to avoid limiting it to jobs in 'green sectors' improving the measurement methodology to better account for progress towards resource efficiency at national level developing a system to asses natural resources, biodiversity and the ecosystem services they provide (EU natural capita) providing a strengthened role of the environment ministers in the European Semester
These conclusions are part of the mid-term review of the 2020 strategy. Together with debates in other Council configurations, they will be the basis for a synthesis report to be endorsed by the European Council in December. Source and more information
Calendar Date
Meeting
Location
2014 October 23
SHE Committee
Brussels
Fecc Membership Meeting
Brussels
November 12
(Board Meeting) 13
International Trade Committee
Brussels
18-19
Excipat Trainings
Brussels
Responsible Care Committee
Brussels
GTDP Committee
Brussels
SHE Committee
Brussels
Fecc Annual Congress
Athens
December 9
2015 January 15 February 17 May 6-8
Contact us! Fecc secretariat +32 2 679 02 60 • Uta Jensen-Korte, Director General ujk@fecc.org
• Alexandra Mengesha, Communications Manager ame@fecc.org
Jan Thienpont, Responsible Care & Logistics Manager
jth@fecc.org
• Joel D’Silva, Life Science & International Trade Manager jds@fecc.org
• Ophélie Roblot, Health Safety & Environment Manager
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 Manager +32 2 679 02 63, ame@fecc.org Editorial staff: Fecc Policy Managers Pictures: Shutterstock, PSD Graphics, member companies and private pictures
Disclaimer The information contained in this newsletter is for general information purposes only. Through this newsletter you are able to link to external websites which are not affiliated with or under the control of Fecc. We have no control over the nature, content and availability of those sites. The inclusion of any links does not necessarily imply a recommendation or endorsement of the views expressed within them.
Rue du Luxembourg 16B 1000 Brussels Belgium +32 2 679 02 60
www.fecc.org