fecc newsletter july/august 2013

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newsleer with clickable web links Inside issue 7 - July/August 2013 2 Members News 4 Fecc Acvies 6 EU Chemicals Legislaon 8 GTDP 10 Internaonal Trade 11 EU & Other News 11 Trends & Stascs www.fecc.org 1 New Fecc Membership Benefits leaflet available F ecc is delighted to share with you a new version of the Fecc Membership Benefits leaflet. The leaflet lists and explains the benefits of becoming an Fecc Member. Members benefit from: representaon before the European Instuons • receive regular updates and advice on relevant industry topics access key informaon via, newsleers, publicaons and guidance documents enjoy an unrivalled networking plaorm Read more on page 4 Happy Holidays! Next issue: September 2013 The Fecc offices will be closed 15 & 16 August Fecc announces change of date for the Fecc Congress Rome 2014 New requirements for acve substances (ASs) imported into the European Economic Area – HMA and MHRA update T he Heads of Medicines Agencies... Read more on page 8 REACH Review workshop - report T he European Commission organised a workshop on the REACH review on 27 June 2013 in Brussels. Main topic of discussions covered the quality of... Read more on page 6 Deloie: M&A provides growth catalyst for chemical industry in 2013 D espite challenges associated with energy and feedstock volality and regulatory policies, the global chemical... Read more on page 10

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Fecc newsletter July/August 2013

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Page 1: Fecc newsletter July/August 2013

newsletter

with clickable web links

Inside

issue 7 - July/August 2013

2 Members News4 Fecc Activities6 EU Chemicals Legislation8 GTDP10 International Trade11 EU & Other News11 Trends & Statistics

www.fecc.org 1

New Fecc Membership Benefits leaflet available

Fecc is delighted to share with you a new version of the Fecc Membership Benefits

leaflet. The leaflet lists and explains the benefits of becoming an Fecc Member.

Members benefit from:• representation before the European

Institutions• receive regular updates and advice on

relevant industry topics• access key information via, newsletters, publications and guidance

documents• enjoy an unrivalled networking platform

Read more on page 4

Happy Holidays!Next issue:September 2013The Fecc offices will be closed 15 & 16 August

Fecc announces change of date for the Fecc Congress Rome 2014

New requirements for active substances (ASs)

imported into the European Economic Area – HMA and

MHRA update

The Heads of Medicines Agencies...

Read more on page 8

REACH Review workshop - report

The European Commission organised a workshop on the

REACH review on 27 June 2013 in Brussels. Main topic of discussions covered the quality of...

Read more on page 6

Deloitte: M&A provides growth catalyst for chemical

industry in 2013

Despite challenges associated with energy and feedstock volatility

and regulatory policies, the global chemical...

Read more on page 10

Page 2: Fecc newsletter July/August 2013

www.fecc.org 2

Members NewsBarentz opens new office and announces new collaborationBarentz opens an office in South Africa

In July 2013, the Barentz group will open an office in Johannesburg. “South Africa is a growth market for us

and up until now, we have done business in South Africa through our European offices. Currently we are involved in so many projects in the Sub Saharan Region, that an own office is inevitable. We will represent Nu-Tek in the region and that is just the first step in the synergies we intend to leverage from our current network of suppliers.” says Hidde van der Wal, CEO of the Barentz group.

As of 2014, a new law will be introduced in South Africa, forcing food companies to reduce the amount of sodium in their products with 20-25%. This new legislation creates opportunities for salt replacing food & nutrition solutions and with the reduced sodium and salt replacement solutions of Nu-Tek, Barentz and Nu-Tek see great potential in this market.

Barentz collaboration with Zamek Food Ingredients Barentz proudly announces its partnership with Zamek Food Ingredients from Germany, offering a comprehensive range of high-quality base HVP (hydrolysed vegetable proteins) products for applications in the savoury food industry, such as soups, sauces and meat products. Zamek has a long history in producing hydrolysed vegetable proteins, applying state of the art process technology.

Barentz will be responsible for the sales, marketing and distribution of the Zamek HVP products in all Barentz Central, Eastern and Southern European countries. This collaboration will further strengthen the Barentz’ Food & Nutrition ingredients portfolio for its customers in the savoury industry, and will create opportunities for new and innovative HVP solutions for the Barentz customers.

Micronized marble dust with whiteness grades of 98-99% – for that extra touch of “extra white”

Nordmann, Rassmann has expanded its range of functional fillers to include the natural calcium

carbonates of its new Spanish partner, Triturados Blanco Macael (TBM). TBM produces ultrapure, micronized marble dust with whiteness grades of 98 – 99%. The company sources its marble from natural quarries located in the Almeria province of southern Spain, where it is strip-mined and then processed directly on site. The grain sizes of the micronized varieties of MICROBLANCO MACAEL 1, 2, 3 and 10 are in the D50 range of 2.5 - 10 µm.As functional fillers, Microblanco products serve another important role in dispersion based systems. Their exceptional

whiteness means that the amount of TiO2 used in various formulations can be reduced, leading to the significant optimization of production costs.

Microblanco products can be used in a markedly wide range of applications such as emulsion paints, varnishes, coatings and printing inks. Use as white fillers in adhesives and sealants, as well as in polymer-bound artificial stone paving tiles (e.g. imitation marble), is also possible. Additionally, they can be incorporated into thermoplastic materials, rubber and both soft and/or hard PVC.30 years of partnership with AsahiKaseiNordmann, Rassmann and AsahiKasei have reason to celebrate: the Hamburg firm and the Japanese manufacturer of engineering plastics (including polyacetal resins and polyamides) have supported one another in a successful business relationship for more than 30 years. Both companies are looking forward to many successful years in future.

IMCD Coatings further invests in its technical capabilities

IMCD Group announced two significant developments for its Coatings Business Group; a 50% expansion of its

Coatings laboratory in Cologne and its new collaboration with French laboratory BioPreserV. Speaking about this new laboratory expansion in Cologne, Dr. Sami Valkama, Technical Manager IMCD Coatings, commented: “This will allow us to focus more on decorative coatings and construction applications in the future and will also provide the opportunity to enhance our technical support for customers and suppliers through the recruitment of further resource.”

In addition to this expansion, Dr. Valkama was also pleased to announce a new collaboration with BioPreserV in Grasse, Southern France. This laboratory will be primarily dedicated to the French market and will cover architectural and industrial coatings with a special focus on coating additives and microbiological studies. On top of the four already existing technical centres, this cooperation reinforces the technical competence of IMCD and the company’s dedication to bring value to its products. More information: www.imcdgroup.com

CBA publishes report on twenty years of RC

The report titled, ‘Twenty years of progress for the UK supply chain’ celebrates the contribution of Responsible

Care to the industry. Over this period, the programme has delivered a remarkable improvement in the supply chain’s management of health, safety, security, and the environment. The report was published on the summer edition of Outlook, available on: www.chemical.org.uk

Page 3: Fecc newsletter July/August 2013

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Members News

SCHOD CR informs about their latest activities

SCHOD CR, the Czech Association, underwent some organisational and

other changes, during the first half of 2013. The General Assembly approved and confirmed these changes to the Board and gave impulse to the modernisation and simplification of the SCHOD CR web sites.

Member companies have activated the access to the Responsible Care Programme. Currently 65% of members (nine companies) fulfil the Responsible Care principles, all of them demonstrate progress towards protecting the environment and have been repeatedly certificated. The other two companies met the criteria and are at the stage of evaluation of auditors and preparation for the public defence. The remaining three member companies entered into the commitment to join Responsible Care Programme, one of which fulfilled a significant part of it. It can be said that 100% of the SCHOD CR at various levels are involved in the Responsible Care Programme. Visit the new website on: www.schod.com

Brenntag announces further expanding of their distribution agreement with Evonik Industries

Brenntag announced that from 1st July 2013, it will distribute the full range of products from Evonik

Household Care in Czech, France, Germany, Italy and Poland. This adds to the distribution agreement between Brenntag and Evonik Household Care in 18 other European countries announced at the end of 2012.

The agreement covers the full product portfolio of the business line “Household Care” from Evonik’s business unit “Consumer Specialties”, which is a global leader in the manufacture and supply of raw materials and additives to the household, detergent, car care and industrial & institutional markets.

AECQ welcomes new members and announces III national congress

AECQ, the Spanish Association welcomes four new members.

The Board of directors announced that UNIVAR IBERIA, S.A., DROGAS VIGO, S.L, QUIMICOS Y DERIVADOS DEL CLORO, S.A. and INTERFAREBA, are the latest companies to join the association. This increases the representation of the association and brings it closer to its objective to represent 100% of the Spanish chemical distribution industry.

The Responsible Care (RC) Committee of the AECQ has authorised the use of the RC logo, to their company members: AZELIS ESPAÑA, S.A., CALDIC IBERICA, S.L., COMERCIAL DE PRODUCTOS QUIMICOS, S.A., DROGAS VIGO, S.L., GLOBAL QUIMIA, S.L. and IMCD ESPAÑA ESPECIALIDADES QUIMICAS, S.A.

Following the success of the first two editions, AECQ will organise the III national chemical distribution industry congress. The congress will take place on November 20, 2013 and will focus on the keys to success for an optimistic future.

currencies against a backdrop of continued challenging market conditions.

Operating income for Q2 was 17 percent lower at €322 million. Net income attributable to shareholders for the quarter rose to €429 million, buoyed by recognition of a deferred tax asset and profit on the divestment of Decorative Paints North America. The acceleration of AkzoNobel’s performance improvement program is on track to achieve the full EBITDA benefit of €500 million by the end of this year, whilst additional charges are expected in the second half of the year as restructuring activities are stepped up.More information and all the figures can be found on: www.akzonobel.com

BASF maintains good business performance in first half of 2013

BASF increased sales by 3% in the second quarter of 2013 to

just under €18.4 billion thanks to higher sales volumes in all segments. Income from operations (EBIT) before special items decreased by 5%, to around €1.8 billion. In the first half of 2013, sales reached around €38.1 billion, surpassing the level of the previous first half by 4%. EBIT before special items increased by 3% to more than €4 billion.

“In light of the challenging conditions, our business performed well in the first half of 2013. Our business with crop protection products contributed substantially to sales and earnings growth. Earnings rose considerably in the Functional Materials & Solutions segment. Higher volumes in the Oil & Gas segment also boosted sales and earnings development,” said Dr. Kurt Bock, Chairman of the Board of Executive Directors of BASF SE.More information: www.basf.com

AkzoNobel Q2 results 2013

Akzo Nobel N.V. reported a 4 percent decrease in revenues in the second quarter compared with the same

period last year. This was due to divestments and adverse

Page 4: Fecc newsletter July/August 2013

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Fecc Activities

The European Association of

Chemical Distributors (Fecc) has changed the date for its 2014 annual congress to 26-28 May. The Fecc Annual Congress is the leading event for the European chemical distribution industry and a key date in the European chemical industry’s calendar. Hundreds of delegates, from business leaders to stakeholders, attend every year.

“Following the great success of the 2013 congress, we’re excited to prepare and host the Fecc congress in Rome. As always at the congress, attendees

Fecc announces change of date for the Fecc Congress Rome 2014Save the date 26-28 May, 2014

will be able to learn and discuss the latest trends in our industry. Ample networking opportunities will be available for the delegates to generatenew business and reinforce existing relationships,” said Uta Jensen-Korte, Director General, Fecc.

More details regarding the programme and sessions will be announced in autumn. Fecc looks forward to welcoming the leaders of our industry in Rome. This change is due to a conflict of dates with other industry events.

Fecc is delighted to share with you a new version

of the Fecc Membership Benefits leaflet. The leaflet lists and explains the benefits of becoming an Fecc Member.

Members benefit from:• r e p r e s e n t a t i o n

before the European Institutions

• receive regular updates and advice on relevant industry topics

• access key information via, newsletters, publications and guidance documents

• enjoy an unrivalled networking platform

New Fecc Membership Benefits leaflet available

• raise their company’s profile• enjoy reduce rates for the congress, seminars and workshops

Inside you will also find key information on our association’s mission and objectives, working committees and

membership categories.

The leaflet is available for download on: www.fecc.org

To receive hard copies of the leaflet, please contact Fecc’s Communication Manager Camila Diaz at: [email protected]

Save the date! Fecc Membership Meeting 201313 November

Fecc is holding its annual Membership

Meeting and Gala Dinner on 13 November. The meeting and evening reception will take place at the Sofitel Le Louise Hotel, Brussels.

During the General Assembly the Fecc working committees will present their latest achievements and objectives. The afternoon programme, theme and speakers will be available shortly.

Meetings in Brief

15-17 July – Fecc Director General Uta Jensen-Korte, visited member companies Lanxess Distribution and Stockmeier. She also visited potential member CG Chemikalien. Dr. Jensen-Korte likes to thank the companies for their hospitality.

Fecc in the News

You can now keep updated on all articles related to Fecc, published in various media outlets. Visit the

section Fecc in the press on our website www.fecc.org to learn more.

Save the date! Fecc Membership M e e t i n g 201313 November

Fecc is holding its annual Membership Meeting and

Gala Dinner on 13 November. The meeting and evening reception will take place at the Sofitel Le Louise Hotel, Brussels.

During the General Assembly the Fecc working committees will present their latest achievements and objectives. The afternoon programme, theme and speakers will be available shortly.

Page 5: Fecc newsletter July/August 2013

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Fecc Activities

Following the retirement of Harry Van Baarlen (Brenntag) and the end

of term of previous Vice-President Enea Marchesi (AssICC); the Fecc General Assembly, ratified the appointments of Gordon Hay and Girgio Bonetti as Board members. Gordon Hay is Brenntag’s Operations Director Europe and Girgio Bonetti is member if the Governing and Executive Council of the Italian Association AssIC.

The Fecc Board consists of twelve members, six company representatives nominated by the Consultative Assembly of Company Members and six members appointed by the Consultative assembly of National Associations.Members of the Board:President: NORDMANN Edgar - Nordmann, Rassmann GmbHVice-President: PRIOR Neville - CBA (UK Association)Fecc Treasurer: SKOU Peter - R2 Group A/S

Fecc Board

BONETTI Giorgio - AssICC (Italian Association)ERICSSON Ann-Christin - P&K (Swedish Association)HARKE Thorsten - Harke GroupHAY Gordon - BrenntagPARELLA Eduardo - QuimidrogaDU PASSAGE Francois - UFCC (French Association)STEINBACH Peter - VCH (German Association)VIÑAS Ramon J. - AECQ (Spanish Association)VERONELLI Nathalie - Eigenmann & Veronelli

Fecc Director General: Uta Jensen-Korte

ICIS top 100 chemical distributors 2013 Published

ICIS Chemical Business magazine

has unveiled its annual ICIS Top 100 Chemical Distributors listing ranked by 2012 sales. The ICIS Top 100 Chemical Distributors is a global ranking based on total sales. Separately, it also lists leaders in key geographies such as North America, Europe, Asia, Latin America and Middle East & Africa based on sales in those regions. The listing also goes beyond the Top 100 companies by sales. This year we provide details on 213 chemical distributors around the world.

To download the publication: www.icis.com

Join the Fecc Comm unicat ions Network

Fecc would like to invite you to the first Fecc communications network

meeting on Monday 16 September 2013 at the Fecc offices in Brussels, from 11:00 to 16:00.

The purpose of this network is to bring together communication and marketing professionals from the chemical distribution industry to discuss issues of mutual interest. Share the needs and challenges faced when carrying out communication and marketing activities and what Fecc can do to address them.

In the first meeting we will discuss topics of interest and activities that can be prepared around them. We will also focus on defining the network and setting out clear aims and visions. If you are interested in attending this meeting, please contact Fecc Communications Manager, Camila Diaz [email protected] before 2nd September.

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Committee News

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GTDP EXCiPACTTM – Next Training course, 7-8 October 2013 Brussels

The next 2-day EXCiPACT™ Training Course will be held 7-8

October in Brussels at Fecc. More details and registration information is available at the EXCiPACTTM website – www.excipact.org

International Trade

IT Committee meeting – Russia and surrounding region of influence – 14

November 2013The next IT committee meeting will be held at Fecc in Brussels on 14 November 2013. The meeting will focus on Russia and the surrounding region of Russian influence. The meeting will feature invited trade specialists as well as distributors doing business in the region. For more information contact Joel D’Silva.

SHE

Fecc organised its latest SHE committee meeting on the 4 July

2013 in Brussels. The meeting was chaired by Michael Paetzold. The 15

participants exchanged views on actions to support SMEs in preparation of the 2018 registration deadline and on the Commission REACH review workshop and they were informed

about the latest ENES platform outcomes.

The nitric acid re-classification and its potential impact on the Seveso sites was introduced and it was agreed to closely follow its developments. Finally the EU consultation regarding occupational safety and health policy framework was presented.

The minutes of the meeting have been circulated and are available on request Contact Ophélie Roblot.

Page 6: Fecc newsletter July/August 2013

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EU Chemicals Legislation

External Events

The European Commission organised a workshop on the REACH review

on 27 June 2013 in Brussels. Main topic of discussions covered the quality of the registration dossier, SMEs and Downstream users.

The Commission and ECHA were/are looking for real case/experience which happened for the 2010 and 2013 preparation in order to find solutions. The aim of the workshop was to get stakeholders opinion and to involve them to prepare 2018.Key conclusions:Dossier quality:• Keep resources for regular updates. • Every intermediate dossier has been

screened. Intermediates: 90% of dossiers updated after letters sent

• 67% of dossiers examined were not in compliance.

• ECHA evaluation of dossiers used to improve data quality:• Selection of dossier for compliance

check: Mix of random and concern-based selection and mix of full and targeted compliance check. Target specifics parts of dossiers where safety matters.

• Screening of all dossiers: substance ID, intermediate status and identify poor entries of insufficient justifications

• Cost for SMEs to submit quality dossiers (need support from who?)

• Need for targeted guidance for SMEs because they use them more than the text law

SMEs:• Cost is an issue for SMEs (reduced

• risks’, to meet locally the companies• Some DU disagrees with the finding

from the REACH review that REACH does not overlap with others EU legislation ( end of life vehicle directive for instance)

• RMM/OCs often too general and restrictive

• Response: ENES, CSR/ES roadmap (publication mid-July),

• Work plan:• Short term: short titles, link

between CSA and ESs, guidance and exemplifying safe use info for mixtures

• Medium Term: harmonisation/standardisation of safety phrases, improve communication to end users

• Long term perspective: facilitate the effective use of REACH info by DUs to comply with their obligations under other legislations

More detailed conclusions are available on the document: Following up the Review of REACH which can be downloaded from the SHE Committee page on the Members Area of the Fecc website. The slides from the workshop have been published on the Commission website, along with the link to the web streaming-recording: ec.europa.eu

REACH Review workshop - report• fees do not make the difference)

some proposals:• Fees based on the production

volume• Payment of fees by instalment• Subsidies• Funding from EU financial

institutions to overcome liquidity problem

• Is industry willing to provide rebates to smaller companies?

• Issue related to SIEF: unfair cost sharing. • Need for more prescriptive

guidance on data sharing. • Set up an official body against

discriminatory practices (UEAPME)• Misuse of SIEFs, possible to have a

legal act to respond to that.• In several cases guidelines took over

the role of the regulation• Cumulative costs of registration for

several regulation (biocides + REACH etc)

• Consultants: ECHA proposal to train them under reflexion

• Guidance in a nutshell on registration available in September

• Communication with SMEs remain difficult, how to reach them? ECHA rely on the others closer from SMEs.

DUs:• SDS cloud management, update in

time, lots of advantages BUT… no evidence of reception

• MS: national plan to reach the unreachable involved several actors (ministeries, chamber of commerce, UIC etc), leaflet without REACH in the title ‘How to deal with chemical

For more information on EU Chemicals Legislation contact: Ophélie Roblot +32 (0)2 679 02 60 [email protected]

For more information and to register your place,8 www.icis.com/europeansurfactants or & +44 (0) 20 8652 3887.When registering please quote promo code FECCEU1

Co-Sponsor:Spotlight Sponsor: Media Partners:

Produced by:

Co-produced by:

Conference sessions this year include:• A world first in packaging – tackling the plastic

pollution problem• Feedstock outlook – oleochemicals and

petrochemicals – will volatility characterise the next 12 months?

• Surfactants and enzymes – friends or foes?

• Key trends and developments in European personal care markets

• A closer look at the European detergent market – what is the outlook?

• Eastern vs Western Europe – reviewing consumption levels and growth forecasts

• Economic outlook for Europe – is it all doom and gloom for the next 12 months?

• Latest technological developments – production of bio-surfactants using bio-ethylene

Speaker representatives have already been confirmed from companies including:• ECOVER • IP SPECIALTIES • EOC SURFACTANTS • EUROMONITOR INTERNATIONAL • KOLB GROUP • INDIA GLYCOLS • TOYOTA TSUSHO CORPORATION, JAPAN • UOPWith more to be announced shortly…

Thursday 12th & Friday 13th September 2013 • Radisson Blu Royal Hotel, Brussels, BelgiumThe 2nd ICIS European Surfactants Conference

Page 7: Fecc newsletter July/August 2013

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EU Chemicals Legislation

ECHA published a roadmap towards

enhancing the quality of information communicated in the exposure scenarios included in the REACH chemical safety reports and in the extended safety data sheets. These documents hold essential information on the safe use of chemical substances and mixtures for downstream users, authorities and REACH registrants alike. The roadmap is a collaborative effort of ECHA and its stakeholders and ECHA now calls for more stakeholders to join in.

The Press Release: echa.europa.euDedicated section on ECHA website: echa.europa.eu

ECHA has published the CSR/ES RoadmapFive specific action areas are:

• Increase common understanding among stakeholders• Information inputs for the chemical safety assessment• IT tools and standardization• Support to formulators

• Support to end-users

ECHA, some member states (Germany, France, Italy, Netherlands, Poland, Romania, UK) and Industry associations (Cefic, Fecc, DUCC members, Concawe, Eurometaux) have signed/will sign the charter to commit themselves to work on the roadmap actions.

Pre-registration phase for Croatian

companies began on 1 July

From 1 July, the REACH and Classification, Labelling and Packaging Regulations

also apply to companies established in Croatia. Croatian manufacturers, importers and producers of articles have a special pre-registration period for their phase-in (existing) substances. This period started on 1 July 2013 and lasts for six months ending on 1 January 2014. Pre-registration is required for Croatian companies to benefit from the extended registration deadlines of 2014 and 2018 foreseen for phase-in substances.

The CLP Regulation requires companies to submit a notification on their CLP classification to the Classification and Labelling inventory one month after a substance has been placed on the market. The one-month period is calculated from the date a substance is placed on the EU market. Companies established in Croatia are now required to submit a classification and labelling notification within one month of placing their chemicals on the market. In practice, this means that all substances on the Croatian market on the date of accession to the EU need to be notified by 1 August 2013.

ECHA has published G u i d a n c e

on information requirements for biocides and on active substance suppliers.The two new guidance documents are applicable from 1 September 2013, the date of entry into operation of the Biocidal Products Regulation (BPR).

The aim of the Guidance on information requirements is to provide detailed and practical direction on the study data and other information that should be submitted, when applying for active substance approval or authorisation of biocidal products according to the BPR. Some of the major differences from the previous BPD guidance include harmonisation with guidance from other legal frameworks when applicable (for example, CLP, REACH and the Plant Protection Products Regulation) and a more formalised and systematic approach for accepting adaptations to information requirements, with Member States having to inform and

ECHA publishes two new Guidance documents concerning biocides

assist applicants with adaptation requests.The present guidance document only covers the information requirements for chemical active substances and chemical biocidal products (i.e. covering Title 1 of Annex II and III of the BPR).

Guidance on information requirements for substances of concern in the biocidal product, Guidance on micro-organisms and Guidance on nanomaterials will be separately available later.

The Guidance on active substance suppliers explains the obligations for companies under Article 95 of the BPR. It provides guidance on who has to submit the required information under Article 95 to ECHA, which information has to be submitted and guidance on the regulatory consequences.

The Guidance document can be found on the ECHA webpage/Biocides Guidance documents echa.europa.eu

Ophélie Roblot, Fecc HSE Manager, spent a week in July at the Brenntag

headquarter office in Chassieu. She was welcomed by Céline Ruer, Brenntag’s France Director Security and environment / HSE Manager and her team. She had the opportunity to see the daily operations of a distributor. While visiting two Brenntag sites (Rhônes-Alpes and Andance) she had the chance to see a driver unloading at a customer’s premises, meet people from the health-security, environment, quality, commercial and legal departments. Ophélie would like to thank Brenntag for this opportunity which is definitely an added value to better understand the distribution business and to represent the industry’s interests.

Fecc HSE Manager spends one week at

Brenntag France

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Page 8: Fecc newsletter July/August 2013

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GTDP

The EXCiPACT™ Association is delighted to announce that two

German manufacturers/distributors have received the first EXCiPACT™ Certificates issued by mdc -medical device certification GmbH - one of their internationally-recognised Certification Bodies.

EXCiPACT™ Certification demonstrates that these organisations manufacture and distribute pharmaceutical excipients according to the EXCiPACTTM Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP)

EXCiPACTTM – First Certificates issued by mdc Germany

Certification Standards.

The award of these first certificates represents an historic landmark for the EXCiPACT™ Association in fulfilling its plans to become an internationally-recognised, free-standing, not-for-profit company later this year. It also concludes the pilot phase of the project in which the Scheme details were extensively checked and tested to ensure that the standards could be implemented as intended.

Source: EXCiPACT™ - www.excipact.org

The Heads of Medicines Agencies (HMA) has released a guideline

document outlining the Falsified Medicines legislation and the process of API import from Third Countries (published 1 July 2013). The UK MHRA has also further elaborated on the process.

According to the UK MHRA for Imports transiting Germany;• When the ASs first enter the EU and

transit other Member States before they arrive in the UK, the UK based importer will need to comply with the requirements of those Member States and may need the assistance of locally-based importers.

• If an AS is imported via Germany under the second waiver, the import requirements are applied at the border.

• In this case, the importer must apply to the relevant competent inspectorate in Germany for a ‘72a Certificate’. As part of this application, the importer will have

Argentina updates list of colour additives permitted in cosmetics

Ar g e n t i n a ’ s regulatory authority

has updated its list of colour additives which will permit previously prohibited substances in perfumes, personal care products and cosmetics.

Source:cosmeticsdesign.com

New requirements for active substances (ASs) imported into the European Economic Area – HMA and MHRA update

• to provide written justification to the German inspectorate for the absence of a Written Confirmation and include a copy of the GMP certificate.

• The importer who applies for the ‘72a certificate’ is normally based in Germany and will contact the local German inspectorate to clarify details.UK importers are advised to arrange such imports in conjunction with a German importer. If the local process is not followed, it could result in consignments being held in Germany.

For more information and the HMA guidance document see - www.hma.eu and www.mhra.gov.uk

EU Cosmetics Regulation becomes fully applicable

On July 11, 2013, the new EU Cosmetics Regulation 1223/2009

became fully applicable. The Regulation, already adopted on November 30, 2009, provides a unified and consolidated framework for the marketing and distribution of cosmetic products on the EU market.

It enters into force following a period of transition allowing industry to adapt to the new rules.

Earlier this year, the final stages of an animal testing and marketing ban for cosmetic products placed on the EU market entered into force on 11 March 2013. As a result of the new Regulation becoming fully applicable, the old cosmetics directive 76/768/EEC is also repealed.

For more information see – European Commission- europa.eu

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India health ministry adds new products to Cosmetics Act

The India Health Ministry’s Drug’s Technical Advisory Board has added a list of six new product categories to schedule S of the drugs and cosmetics act.

Source: cosmeticsdesign-asia.com

Page 9: Fecc newsletter July/August 2013

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GTDP

An update document is available from the General Secretariat of

the Council of the European Union (19 June 2013) pertaining to the progress of the Falsified Medicines Directive.

According to the update document to date, twenty infringement proceedings have been launched against those Member States which have not notified the Commission the national transposition measures taken to comply with the Falsified Medicines Directive. Since then, 9 Member States have notified transposition measures and the Commission is currently analysing these measures.

The Commission has official information from all important active substance exporting countries that they have started issuing the “written confirmation”, unless they have been “listed” by the Commission in accordance with Article 111b of Directive 2001/83/EC. Commissioner Borg visited India and China in April and June 2013 to seek the cooperation of the local competent authorities. India has issued over 110 written confirmations (out of 190applications). China started issuing written confirmations in mid-June.

Provisions relating to the import of Active Pharmaceutical Ingredients in the Falsified Medicines DirectiveUpdate from the Commission – June 2013

Mexico Amends API Manufacturing Regulations to Meet EU Requirements

Mexico’s Ministry of Health has updated the country’s

requirements on Good Manufacturing Practices (GMPs) for active pharmaceutical ingredients (APIs). The new GMP requirements come into force with immediate effect and are mandatory for all establishments engaged in the manufacture and distribution of APIs.

With this Mexico believes that it has met the requirement for API exports to the EU under the EU Falsified Medicines Directive, which comes into force on 2 July 2013.

Source: Cofepris: www.cofepris.gob.mxMore information on: www.drugregulations.org

Taiwan, South Korea, Israel, Ukraine, South Africa, Singapore and Argentina have also started issuing the “written confirmation”, while Canada, Mexico, Russia, and Turkey are expected to start shortly.

The Commission has intensified the“listing activities” under Article 111b of Directive 2001/83/EC. Switzerland, Australia, the Unites States and Japan are now listed. These countries will be able to export to the EU without written confirmation. In addition, for Brazil, the equivalence assessment is on-going. Israel and Singapore are modifying their legislation to be re-considered for listing.

Argentina, Mexico and Malaysia are expected to apply for listing later this year. To prevent shortage of medicines, Member States have the possibility to allow active substances to be imported from a third country if accompanied by an EU good manufacturing practicecertificate. To date, Italy, Spain and the United Kingdom have communicated to the Commission their intention to use this exception.

Source: Council of the European Union - register.consilium.europa.eu

For more information on GTDP contact: Joel D’Silva +32 (0)2 679 02 62 [email protected]

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International TradeBrazil chemicals trade deficit seen at record despite depreciation

Brazil’s chemical products trade deficit reached

$4.3 billion during the first 2 months of this year, according to figures released by Abiquim (São Paulo). The deficit increased by 16.8% compared with the first 2 months of 2012. Brazil, during this period, imported $6.6 billion in chemical products, an increase of 11.4%. Exports stood at $2.3 billion, only a 2.4% increase compared with January and February of last year.

Source: www.bnamericas.com

Russian chemicals trade body to create chemical products database

The Russian Chemists Union

(RCU) is to create a Russian language database of chemical products and post it on its website, according to the International Confederation of Chemical Associations (ICCA). The initiative builds on a meeting in April organised by the RCU and BASF to help promote the chemical industry’s voluntary Global Product Strategy - a key part of its contribution to the UN’s goal of achieving safe management of chemicals accross the globe by 2020.Source: chemicalwatch.com

EU and Moldova conclude Deep and Comprehensive Free Trade Area

The DCFTA will bring Moldova’s economy closer to that of the EU.

The DCFTA consists of 14 chapters; it will provide for a significantly improved mutual access for European and Moldovan goods and services. Furthermore, it will ensure an open, stable and predictable legal environment for the benefit of Moldovan businesses and consumers. The DCFTA will improve the trade opportunities between EU and Moldova and enhance prosperity of both economies.Source:

DG Trade - trade.ec.europa.eu

Despite challenges associated with energy and feedstock volatility and

regulatory policies, the global chemical industry is poised for modest growth in 2013 with merger and acquisition (M&A) activity likely to be a key factor in helping companies achieve top line growth. According to a new report from Deloitte Touche Tohmatsu Limited’s (DTTL) Global Manufacturing Industry group, 2013 Global Chemical Industry Mergers and Acquisitions Outlook, the global chemical industry is experiencing a portfolio realignment putting increased pressure

Deloitte: M&A provides growth catalyst for chemical industry in 2013

on companies to find new growth markets.

The report identifies multiple factors driving growth of M&A activity around the world particularly for North America, Europe, and China including new markets, shale gas discoveries and the progression of the Advanced Materials Systems industry. This is in spite of continued Eurozone concerns and slow recovery in other mature markets. For the report see: www.deloitte.com

KPMG – 2012 Chemicals and Performance Technologies Industry Outlook Survey

KPMG International takes an in-depth look at the global chemicals and performance technologies industry by focusing on the results of KPMG’s

2012 Industry Outlook Survey. This annual survey polls chemicals industry executives from the US, Europe, and the Asia Pacific region. The survey covers the industry outlook for business conditions, M&A, capital spending, revenue, headcount and other key categories across the three regions. For the survey and report see: www.kpmg.com

Indonesia to regulate certain chemicals in toys

The Indonesian government is to impose limits on phthalates,

formaldehyde and azo dyes in toys, manufactured domestically or imported, from October.

According to the Decree on implementing standards for toys (No. 24/M-IND/PER/4/2013), the inclusion of phthalates cannot be over 0.1% for toys of certain materials manufactured or imported into the country. It also specifies that formaldehyde in certain toys cannot be more than 20ppm, and that no azo dyes are permitted in most of the toys covered by the decree. There will be additional technical guidance issued in October to explain the classification of phthalates derivatives, according to the Ministry of Industry, which regulates toy products in the country. Source: Chemicalwatch

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For more information on International Trade contact: Joel D’Silva +32 (0)2 679 02 62 [email protected]

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EU & Other News

Trends & Statistics

The board of the European Investment Bank, comprising

directors from 28 EU member states and the European Commission, approved significant new support for stimulating investment by SME and mid-cap companies (up to 3000 employees). The board also agreed new initiatives for tackling youth unemployment and providing trade finance for export focused European companies in programme countries.

The board today approved a significant increase of the lending target for SMEs

EIB delivers on increased SME lending and approves support for youth employment

EUR 9.4 billion compared to EUR 6.4 billion in the same period last year.

Source and more information on: www.eib.org

during 2013, up from the originally planned EUR 14.1 billion to EUR 17 billion. This brings the overall EIB Group support close to EUR 20 billion, with the European Investment Fund focussing on venture capital, guarantees and microfinance.

The board also approved EIB loans totalling EUR 3.8 billion for lending to small and medium sized businesses and mid-cap companies across the EU. This will bring total EIB support for European SMEs and mid-caps approved so far in 2013 up to some

European chemicals output will contract by 1.0% this year

before returning to modest growth of 1.5% in 2014, Cefic, the European Chemical Industry Council, has said. The 2013 figure is lower than the 0.5% slight expansion announced in December 2012, as the economic development to date has been weaker than expected.

The gradual recovery will be founded upon stabilization of industrial production in Europe after two years of weakness, and a modest rise in exports. But the European chemicals sector, which generates 1% of the continent’s gross domestic product and which employs 1.2 million, will face tough competition from U.S. producers benefiting from cheap energy and feedstock.

The 1.0% fall in European chemical output during 2013, compared with 2012, will be the second consecutive year of modest output decline. Important industrial markets for European chemicals are continuing to struggle. Although demand is stronger in some individual countries, both automotive and construction remain generally weak. Sales of new vehicles are being held back by high

Tough conditions lead to EU chemicals output contraction this year, growth returns in 2014

Consumer chemicals, a subsector that will remain in positive growth territory in 2013, will further expand by 1.5% next year followed by a 1% uptick for inorganic basic chemicals. Employment in the sector is forecast to remain stagnant.

The upturn in chemicals output depends on a modest recovery in the wider European economy. Industrial production in Europe is currently stabilizing after fiscal

consolidation and structural reforms in many countries have helped establish a firmer base for renewed growth, albeit at the cost of higher unemployment. Demand is expected to improve modestly across the economy during 2014.

More positively, world manufacturing output growth is expected to accelerate in 2014 after two years of slower progress. This should strengthen export demand both for European chemicals, and for products that contain them. Japan is striving to re-launch its economy, a US recovery is underway, and developing and newly-industrialised economies are continuing to expand rapidly, becoming important consumer markets.Source: www.cefic.org

unemployment and weak income growth, although the need to replace older vehicles will in time help to revive the market.

Working off the excesses of past speculative building activity is happening at a painfully slow pace, and European construction output remains at historically low levels. The disappointing performance of the chemicals industry tracks the weak level of activity in the broader European economy, particularly in the Eurozone.

Cefic forecasts a return to moderate positive growth for chemicals output in 2014 of 1.5%. Petrochemicals and fine and speciality chemicals sub sectors both are predicted to grow by2%.

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Trends & Statistics

EU chemicals production contracted 2.1 per cent in the first five months

of 2013 compared with the same period in 2012, according to the latest Cefic Chemicals Trends Report released today. Monthly production data for May showed a 1.1 per cent drop compared with the same month the year prior.

The EU chemicals net trade surplus improved through the first four months of the year, latest data show, reaching €16.9 billion, up €1.9 billion on the same period last year. EU chemicals prices were lower on a

Cefic Chemicals Trends Reportyear-on-year basis in May, falling 1.8 per cent during the month against the comparable month in 2012. Sales were 3.3 per cent lower in the January-April time period compared with the first four months of the year prior, and remain 2.7 per cent lower than the peak level reached in third quarter 2008.

Complete report and more information available on: www.cefic.org

Calendar 2013Date Meeting Location

16 September Communications Network Brussels

17 September Fecc/ECSA PS Workshop “Chlorinated Solvents – the time is over to only sell a product”

Brussels

18 September Product Stewardship Committee Brussels

23 September Responsible Care Committee Brussels

26 September Congress Committee Hamburg

27 September Board Meeting Hamburg

1 October Precursors Committee Brussels

7 October ESAD Steering Committee Brussels/Cefic

7 & 8 October Excipact Training Course Brussels

22 October SHE Committee Brussels

4 November Logistics Committee Brussels

7 November GTDP Committee Brussels

13 November Fecc Membership & Board Meeting Brussels

14 November International Trade Committee Brussels

18-21 November NACD Annual Meeting Marco Island, Florida, USA

11 December Responsible Care Committee Brussels

Fecc Meetings

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Contact us!Fecc secretariat +32(0) 2 679 02 60• Uta Jensen-Korte, Director General [email protected]• Camila Diaz, Communications

Manager [email protected]• Jan Thienpont, Responsible Care &

Logistics Manager [email protected] • Joel D’Silva, Life Science &

International Trade Manager [email protected]• Ophélie Roblot, Health Safety &

Environment Manager [email protected]• Catherine Lefranc, Assistant [email protected]

Owner and Publisher:

The European Association of Chemical Distributors (Fecc)Rue du Luxembourg 16B, B-1000 Brussels, Belgiumwww.fecc.org

Chief editor: Camila Diaz, +32 26790263,[email protected] staff: Fecc Policy ManagersPictures: 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 endorse the views expressed within them.

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