Inside this issue

Members’ news 2

Fecc Activities 7

EU Chemicals Legislation 8

GTDP 12

International Trade 15

EU & Other News 16

Calendar 17

Issue 7- November 2014

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 chem-

ical 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 competi-

tiveness and innovation.

Read More

Brenntag joins UN Global Compact

UN Global Compact, a voluntary initiative set up to promote sustainable development and social responsibil-

ity. 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 incor-porate 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 ac-tivities and strategies with ten universally recognized principles in the areas of human rights, labor standards, envi-ronmental 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 participa-tion in the plastics and chemical distributor. Biesterfeld Vermögensverwaltung GmbH & Co. KG, cur-rently holding 100% of the shares in Biesterfeld AG, and HANNOVER Finanz Group, Hannover, agreed on the ac-quisition of 28.6% of the shares of Biesterfeld AG by the latter. This agreement still awaits approval by the Ger-man 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 envis-aged, now converted into a minority shareholding inter-est 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 part-ner who has vast experience in the development of me-dium-sized enterprises. This step ensures the further development and growth of our Group as a family-owned 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 Fi-nanz 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®. Caldic, distributor and producer of chemicals and food ingredients in Europe, Asia and North America simplifies the silicone industry by acquiring RoRe Technologies ear-ly July 2014. Relocated to the Caldic plant in Lyon, this acquisition emphasizes Caldic’s ambition to strengthen its position as a leading full service distributor providing innovative products, value added services and total solu-tions. Acquiring this factory will contribute substantially to the company’s production capacity, added value and solu-tion development capabilities. Caldic strengthens its Calsil® silicone brand with RoRe Technologies’ long ex-pertise 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

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 food-processing and personal care solutions. From world-class Kosher-grade preparations, to bespoke emulsions & dis-persions, this silicone expertise turns into tailored solu-tions to fuel our geographic expansion” says Philippe Rovere, Silicone Division and Calsil® Brand Manager.

With this strategic acquisition, Calsil® demonstrates yet again the pertinence of “Simplifying Silicone Solutions”, offering an inspiring and competitive alternative in sili-cone sourcing. Source and more information

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 ‘composites-related’ 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 Wolfan-gel, the world known family enterprise producing ranges of the whole FRP equipment from small gelcoaters, chop-per, 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 ex-piration 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

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 Ser-vices 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 opera-tions 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 Singa-pore. 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

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

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 ser-vices, 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 applica-tions 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. The award reflects how Dow Corning played a key role in integrating sustainability throughout Henkel's entire val-ue chain, helping the company get closer to the targets set out in its sustainability strategy. Through a proactive approach, Dow Corning tackled

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 busi-ness partners based on a common vision and goals. Dow Corning's sustainability concepts in terms of materi-al supply, energy reduction and waste control directly align with Henkel's sustainability goals." Source and more information

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 29-percent 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 AgriNutri-tion – 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 im-

pact of the EU regulatory framework on the industry. This meeting will give us an overview of the ongoing initia-

tives 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 presen-tation 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 Regis-

try 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 evi-

dence etc.).

For more information:

Questions & Answers

Factsheet [PDF]

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

EU Chemicals Legislation

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)-2,2-dimethylcyclopropanecarboxylate *CAS number 609346-29-4

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 pro-

posal 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 enforce-

ment of chemicals or related legislation like protection of human health and safety and the environment to pro-

mote 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 enforce-

ment 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

EU Chemicals Legislation

For more information on Chemi-

cals Legislation, please contact:

Ophélie Roblot +32 2 679 02 68

oro@fecc.org

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.

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_endocrine-

disruptors_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 in-

formation 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 communiqué 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 | Communiqué

EU Chemicals Legislation

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 en-

gine. The Eudralex V29 is similar to the EudraLex currently available, but it can be used off-line with the search en-

gine. 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-deficiencies-

2013.html

EMA: Reflection Paper on API Starting Materials

The European Medicines Agency (EMA) has released a “Reflection paper in the requirements for selection and justi-

fication of starting materials for the manufacture of chemical active substances”. It aims to clarify some of the ex-

pectations 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-api-

starting-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 enti-

tled “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-drug-

inspection.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 cos-

metics, 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/Regulation-

Safety/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'-(1,4-

piperazinediyl)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-concentration-

of-10-for-UV-filter-in-sunscreens

The European Commission has adopted two measures

restricting the use of three preservatives in cosmetic

products. The Commission decision follows an assess-

ment by the independent Scientific Committee on Con-

sumer Safety (SCCS), an advisory body which carried out

a careful risk assessment of the substances before rec-

ommending their restriction or ban.

With the adopted measures the Commission limits

the maximum concentration of two preserva-

tives, 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 indi-

vidually or together. They are being banned from leave-

on products designed for the nappy area of young chil-

dren below the age of three since existing skin irritation

and occlusion may allow increased penetration than in-

tact skin. The new rules will apply for products put on

shelves after 16 April 2015.

Secondly, the Commission bans the mixture

of Methylchloroisothiazolinone (and) Methylisothiazoli-

none (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 reas-

sessment. Products placed on the market after 30 Octo-

ber 2014 will have to be free from these substances. Source: European Commission - http://europa.eu/rapid/

press-release_IP-14-1051_en.htm

European Commission adopts measures on three preservatives in cosmetic products

Court of Justice of the European Union (ECJ) Judgment on Aci-no 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 author-ised 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 con-firmed that the Commission is entitled to act on the basis of considerations which are "based on solid and persuasive evi-dence 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 con-firmed that competent authorities may suspend marketing authorisations or withdraw products from the market in case of serious GMP failures in a manufacturing site.

GTDP

For more information on Interna-

tional 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 doc-

uments. 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 agree-

ment. 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, includ-

ing 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 develop-

ments and thus provides transparency and upholds the competitiveness of EU exporters. The updated list also re-

flects 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 Interna-

tional 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 EU-

Singapore 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 cus-

toms 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 non-binding aspirational target

taking into consideration circular economy principles and the potential for green employment in the Euro-pean 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

November

12 Fecc Membership Meeting

(Board Meeting)

Brussels

13 International Trade Committee Brussels

18-19 Excipat Trainings Brussels

December

9 Responsible Care Committee Brussels

2015

January

15 GTDP Committee Brussels

February

17 SHE Committee Brussels

May

6-8 Fecc Annual Congress Athens

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

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