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Inside this issue Members’ news 2 Fecc Acvies 7 EU Chemicals Legislaon 9 GTDP 14 Internaonal Trade 16 EU & Other News 16 Calendar 17 Issue 8– December 2014 Celebrate our Success ! BECOME A SPONSOR TODAY

Newsletter December 2014

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Page 1: Newsletter December 2014

Inside this issue

Members’ news 2

Fecc Activities 7

EU Chemicals Legislation 9

GTDP 14

International Trade 16

EU & Other News 16

Calendar 17

Issue 8– December 2014

Celebrate our Success !

BECOME A SPONSOR

TODAY

Page 2: Newsletter December 2014

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 forc-

es. 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 chemi-

cal distribution, reports solid growth in gross profit and oper-

ating 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’ earn-ings 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 EastmanTM

products for paint and coatings applications.

Eastman Chemical is one of the leading specialty chemical producers worldwide. Its product range comprises Cellulose Es-

ters, 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 pro-

vides inhouse laboratory services. Eastman Chemical and Krahn Chemie have been working successfully together in the Ger-

man market for many years already.

Source and information

Page 3: Newsletter December 2014

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 dura-bility, 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 re-sistance 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 com-mitment 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

Members’ news

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 Spe-zialchemie GmbH. Dr. Straetmans is well known as a leading supplier of multifunctional products for the cosmetics industry with a focus on cos-metic 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

Page 4: Newsletter December 2014

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, Win-tershall will also assume the operatorship of the Vega production field.[1] The transfer of operatorship from Statoil to Win-tershall is planned for the end of the first quarter of 2015. For more source and information

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 re-quired 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

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 Jan-

uary 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 Spe-

cialty Chemicals and value added Calcium Carbonate products. See more at: http://www.algol.fi/en/news-and-releases/

Page 5: Newsletter December 2014

Members’ news

Univar Expands in Brazil Market with Acquisition of D’Altomare Química Ltda

Univar Inc., a leading global chemical distributor of industrial and specialty chemicals and related chemistry ser-vices, announced today it has acquired D'Altomare Química Ltda., a Brazilian distributor of specialty chemicals and ingredients, through Univar Brasil Ltda. The acquired business will be combined with Univar’s Brazil operations. “This transaction expands Univar’s geo-graphic footprint and market presence in

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 ser-vice provider in high-growth specialty markets including personal care, phar-maceuticals, electronics and aviation.” For more than 40 years, D’Altomare has specialized in the distribution of chemis-tries and specialty ingredients for the pharmaceutical, personal care, food, agriculture, transportation and other industrial markets. The company has headquarters in São Paulo, and operates distribution facilities in Embu and Ma-naus. “We are confident that the opportunity of combining D’Altomare with Univar will

offer new potential not only for our cus-tomers, but also our suppliers and em-ployees,” 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, com-

ments: “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 ex-

isting 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 ser-

vices 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

Page 6: Newsletter December 2014

Members’ news

Dow to Add New Independent Directors to Its Board

The Dow Chemical Company (NYSE: DOW) announced it will add four new independent direc-tors 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 Ex-ecutive 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

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 ma-terials 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 nu-trition 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

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

UFCC ( UNION FRANÇAISE DU COMMERCE CHIMIQUE) informed us that Unipex' CSR commitment was evaluated and awarded Silver level. Read more

Page 7: Newsletter December 2014

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 mem-

bers 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.

Page 8: Newsletter December 2014

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, envi-

ronmental 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

Page 9: Newsletter December 2014

EU Chemicals Legislation

Safety tips: Always keep liquid laundry detergent cap-sules away from children You might have heard that there have been a number of accidental exposures in young children with liquid laundry deter-

gent 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 deter-

gent 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 pack-

age, 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 guar-

antee 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.

Page 10: Newsletter December 2014

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 deliv-

er 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

• 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 quali-ty

– Structured 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 classifica-tion 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) – BAuA project

– Further evaluation needed

– Workshop in Helsinki: March 2015

Page 11: Newsletter December 2014

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 lease 1Q2016 (after testing)

– Chesar 3 alignment with recent/upcoming developments: e.g. use maps, export in ESCOM XML format, implement Structured Short Titles

– Chesar training and promotion planned

• 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-hydroxy- 3-((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

Page 12: Newsletter December 2014

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 classi-

fication 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

EU Chemicals Legislation

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 tech-

nical 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

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-(2,6- difluorobenzoyl)urea

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 regis-

tration due to the failure of the registrant to pay the supplementary registration fee.

BoA decisions

Page 13: Newsletter December 2014

EU Chemicals Legislation

Reminder to submit substance in article (SiA) notifications by 16 December 2014 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 noti-

fication is mandatory for all articles containing SVHCs currently included in the Candidate List if the conditions for the notifica-

tion obligation are met.

Candidate List | Notification of SiA | Webform & REACH-IT using IUCLID

For more information on Chemicals

Legislation, please contact:

Ophélie Roblot +32 2 679 02 68

[email protected]

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

Page 14: Newsletter December 2014

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 - [email protected]

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 manufactur-

ing 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 guide-line "Guideline on similar biological medicinal products".

Source: GMP Publishing - http://www.gmp-publishing.com/en/gmp-news/gmp-aktuell/ema-guideline-biosimilars-principles-2014.html

For more information on Interna-

tional Trade, please contact : Joel

D’Silva

+32(0)2 679 02 62—[email protected]

Page 15: Newsletter December 2014

GTDP

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 Administra-tion (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 excipi-

ents 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/

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 Therapeu-tics 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 decid-ed 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:

Page 16: Newsletter December 2014

International Trade

For more information on International

Trade, please contact : Joel D’Silva

+32(0)2 679 02 62—[email protected]

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

Page 17: Newsletter December 2014

Calendar

Date Meeting Location

2015

January

15 GTDP Committee Brussels

February

17 SHE Committee Brussels

March

12 BOARD Meeting Brussels

17-18 EXCiPACT Training Brussels

20 Responsible Care Brussels

April

23 ESAD Steering Committee Cefic, Brussels

May

5 BOARD Meeting Athens

6-8 Annual Congress Athens

June

10 Responsible Care Brussels

July

29 SHE Committee Brussels

September

8 Responsible Care Brussels

23 BOARD Meeting Hamburg

29 ESAD Steering Committee Fecc, Brussels

October

21 SHE Committee Brussels

November

25 BOARD Meeting Brussels

December

3 Responsible Care Brussels

Page 18: Newsletter December 2014

Contact us!

Fecc secretariat +32 2 679 02 60

• Uta Jensen-Korte, Director General

[email protected]

• Alexandra Mengesha, Communications Manager

[email protected]

• Joel D’Silva, Life Science & International Trade Manager

[email protected]

• Ophélie Roblot, Health Safety & Environment Manager

[email protected]

• Sarah Anhorn, Office Manager

[email protected]

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, [email protected]

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.

Page 19: Newsletter December 2014

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