Fecc Business Plan 2015

European Association of Chemical Distributors

Business Plan 2015 November 2014

www.fecc.org

Table of Contents

Foreword.................................................................................................................. 3 Executive Summary.................................................................................................. 4 Fecc 2014 survey (Data 2013).................................................................................... 8 International Trade Committee................................................................................12 SHE Committee........................................................................................................13 Responsible Care Committee...................................................................................15 Product Stewardship Committee..............................................................................18 GTDP Committee......................................................................................................19 Precursors Committee.............................................................................................20 Logistics Committee.................................................................................................22 ESAD Steering Committee........................................................................................23

Fecc Secretariat Uta Jensen -Korte – Director General Sarah Anhorn – Office Manager Joel D’Silva – Life Science & International Trade Manager Alexandra Mengesha – Communications and Membership

Development Manager Ophélie Roblot – Health, Safety & Environment Manager Jan Thienpont – Responsible Care & Logistics Manager

2 | Fecc Business Plan 2015

Foreword

The Chemical distribution industry is a vibrant of the recent significant work efforts and and professional industry which has demonaccomplishments made by Fecc, in particular strated its strength by overcoming challenges that of the expert working committees. and emerging intact A revised strategy despite the economic will be presented context of recent for approval at the Moving ahead Building a years. Without a Extraordinary General doubt, the industry Sustainable Future Assembly Meeting plays a key role in at the Membership the supply chain Meeting in November. and truly adds value to the manufacturers which distributors work On a positive note, the past year has seen closely with and to the customers they serve. our association gain two additional members; In response to these realities the chemical distriCGÂ Chemikalien and 2M Holdings; both of them bution industry has to continue seeking ways are true success stories in the chemical distributo add further value and to answer customer tion industry. Membership development remains demands. It is a fact that there is an ever a priority to strengthen our position as the Euroincreasing legislative burden impacting the pean Voice of the Chemical distribution industry. industry. Whilst we welcome the initiatives of In 2015, Fecc will continue working to ensure the the European Commission to improve the reguchemical distribution industry is sustainable, and latory landscape, it is also vital that distributors that our members remain fit to tackle the chalare fit for purpose, ensuring they meet all legal lenges of the future. and environmental requirements.

Wishing you a pleasant reading, The Business Plan 2015 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 Dr. Uta Jensen-Korte, Director General

Dr. Uta Jensen-Korte Director General

Fecc Business Plan 2015 | 3

Executive Summary

Fecc Board Fecc President : Neville Prior – CBA (UK Association) Fecc Vice-President : Francois-Xavier du Passage – UFCC (French Association) Fecc Treasurer : Peter Skou – R2 Group A/S Fecc Honorary President : Edgar E. Nordmann (NRC) Giorgio Bonetti – AssICC (Italian Association) Ann-Christin Ericsson – IKEM (Swedish Association) Thorsten Harke – VCH (German Association) Gordon Hay – Brenntag

David Jukes – Univar Eduardo Parella – Quimidroga Frank Schneider – IMCD Nathalie Veronelli – Eigenmann & Veronelli Ramon J. Viñas – AECQ (Spanish Association)

Director General : Uta Jensen-Korte

Fecc in a Nutshell Our Mission Promote the chemical distribution industry in order to ensure a sustainable business environment for the sector in the short, medium and long term. Fecc represent members’ interests at the European and international level, while fostering cooperation within the chemical distribution sector.

Membership Benefits

Advocacy

Expertise

We are THE voice of our industry

Networking

Objectives ,,Monitor

regulatory affairs and represent the industry’s views before the European Institutions. ,,Increase sustainability by promoting the implementation of the Responsible Care Programme. ,,Serve as a platform to reach out to internal and external stakeholders. ,,Provide expertise and advice to the members. ,,Strengthen relations between the chemical distribution industry.

Vision “Become THE opinion maker within our Industry so that we are the natural partner for our members, European Institutions and stakeholders”.

4 | Fecc Business Plan 2015

Communications

Representation : Fecc actively participates in the European policy development. Representing the industry’s interests and views before the European Institutions, through commenting and contributing in consultations relevant to our members.

Working Committees : Expert committees’ work on diverse topics important for the chemical distribution industry. The committees develop advocacy positions and provide the members with regular updates and advice on key industry information, market developments and relevant legislation.

Key Information : Fecc’s members receive key information via newsletters and subject

Executive Summary

specific publications and guidance. The website members’ area hosts a wide range of documents such as guidelines, expert views on relevant regulation and fact sheets, on issues important to the chemical distribution industry.

Networking : Fecc serves as a platform where members benefit from unrivalled networking opportunities. Fecc develops and maintains close relationships with other industry associations that allow our members to connect with industry leaders and key stakeholders.

Promotion : Fecc will raise company members’ profile through its communications tools such as the members’ section of the newsletter, website and publications.

Discounts : Members also enjoy reduced rates, for the Annual Congress, seminars and workshops.

Members We strive not only to offer our members a wide range of benefits, but also to serve as platform to foster co-operation within our industry.

Developing our membership is a priority and absolutely imperative to strengthen our position as the European voice of the chemical distribution industry.

In 2014, Fecc welcomed two new company members, CG Chemikalien and 2M Holdings.

Founded in Laatzen near Hanover, Germany in 1962. CG Chemikalien, a family-owned business, has continuously evolved and established itself in many markets. 2M Holdings is a leading international chemical distributor and a wholly owned private company headquartered in the UK. 2M Holdings has six branded companies in six world-wide locations : UK, Ireland, Belgium, Poland, Norway and China.

Fecc and ICCTA On May 27, 2014, Fecc Treasurer Peter Skou was elected President of the International Council of Chemical Trade Associations (ICCTA). As member of the Fecc Board, Mr. Skou has skilfully served

as Fecc treasurer for the past four years, playing a pivotal role in the recent developments of the association. Mr. Skou has acquired vast experience in the industry as Managing Director and part owner of the successful distribution company R2 Group A/S. ICCTA provides a platform where chemical distributors from many different countries can meet and exchange information and best practises. Fecc and its national associations actively participate at the ICCTA meetings with the aim to exchange views on practical matters related to Responsible Care/Responsible Distribution/Social Responsibility initiatives.

REACH The preparation for the 2018 registration deadline and the dedicated support to SMEs, the authorisation process, extended Safety Data Sheets (SDS) related issues and the supply chain communication, maintained REACH as an important topic during 2014. In this context Fecc advocates for the simplification and reduction of the overall costs of the process. Fecc is actively involved in the Expert Network on Exposure Scenarios (ENES) platform set up to promote workable solutions and practical improvements for exposure scenarios implementation. Fecc is intensively monitoring the new developments for nanomaterials, polymers and endocrine disruptors which are still under discussion and may impact heavily our industry.

CLP Fecc follows closely the European Commission’s activities with regard to the transposition of the 5th revision of the GHS into CLP and the activities related to the harmonisation of information to Poison Centres. The proposal for nitric acid reclassification was a priority topic during 2014 which was successfully tackled thanks to unified industry sector’s contributions.

Seveso Fecc follows the discussion on the development of methodologies to implement article 4 of the Seveso III Directive. Article 4 was newly

Fecc Business Plan 2015 | 5

Executive Summary

introduced by Seveso III and it aims at providing exemptions for substances for which it is impossible in practice to cause a release of matter or energy that could create a major accident under both normal and abnormal conditions which can reasonably be foreseen.

Biocides To support the implementation of the Biocidal Product Regulation, Fecc updates and advises companies on their obligations and the procedure to follow in order to place a product on the market.

EXCiPACTTM certification scheme In 2014, EXCiPACT became a free-standing, notfor-profit association (asbl) under Belgian law.

Fecc is a member of the Board and is actively involved in the workings of the certification scheme. Fecc also supports the initiative by hosting and organising the EXCiPACT Training programmes. EXCiPACT certificates have been issued in Canada, France, Germany, The Netherlands, and Saudi Arabia.

A group of industry experts from the European Fine Chemicals Group (EFCG), the International Pharmaceutical Excipients Council Europe (IPEC Europe), IPEC Americas, the European Association of Chemicals Distributors (Fecc), and the Pharmaceutical Quality Group (PQG) are working together on this scheme.

International Trade Fecc’s International Trade Committee informs and updates its members on European and International chemical trade policy and trends.

It provides market oriented information and updates, particularly on emerging markets and regions. The Committee also drafts and circulates factsheets containing macro-economic and chemical industry related data in focus regions. The Committee closely monitors issues pertaining to Free trade agreements (FTAs), antidumping investigations, sanctions as well as EU imposed restrictions.

6 | Fecc Business Plan 2015

Pharma, Food, Feed and Cosmetics Fecc’s Good Trade and Distribution Practice (GTDP) Committee has actively followed and formulated Fecc’s positions pertaining to the distribution of pharmaceutical starting materials, APIs and excipients. It also follows all regulatory activity in the food, feed and cosmetics industries, where it monitors European and international initiatives and works actively to define Good Trade and Distribution Practices for these sectors.

The Committee regularly invites external experts to its meetings to update its members on current and emerging issues pertaining to the pharma sector in particular regulatory activities, GMPs and GDPs.

Responsible Care Responsible Care (RC) is and always will be a top priority for Fecc. Fecc will use every occasion to promote RC and the Fecc EU RC programme.

2013 and 2014 have been years of consolidation as the majority of the company subsidiaries applications have matured and completed the application phase with a TPV assessment. However some of them have demonstrated challenges during implementation.

The Fecc programme itself has shown a number of areas for improvement : the overall quality management of the programme should be enhanced and some inconstancies within the current programme text should be resolved.

Executive Summary

In order to limit the number of drop outs and increase the overall quality of the programme, Fecc should step up the pace and assist the companies and associations in implementing the programme, where resources permit.

Product Stewardship In 2013, the Product Stewardship Committee went through a substantial change : although the emphasis remains on creating a platform where manufacturers and distributors come together, a new framework of the Committee was adopted with the intent to become a specialist forum, where specific distributor industry issues can be discussed with stakeholders throughout the complete supply chain. This approach has been consolidated during 2014 and will be the main focus of the Committee in the coming years.

Precursors Due to the nature of the activity in this area, the Precursor Committee only meets when there are substantive items to discuss in detail, whilst the committee was relatively active in 2014 there was only the need to meet once with the bulk of the activity being handled on-line or via teleconference. The Committee and Secretariat monitor the developments in CBRNE, PIC, Dual Use and the explosive and drug precursor’s regimes.

Logistics The Logistic Committee held one meeting in 2014.

Its main topic was the monitoring of the regulatory developments at the UN model and regional modal levels. Fecc participated in several initiatives such as the ECTA work group “safe loading and unloading”.

Fecc Business Plan 2015 | 7

Fecc 2014 survey (Data 2013)

The results of the 2014 collection (data 2013) show that Fecc’s member associations represent around 840 chemical distributors, around 29,000 employees at over 1,300 sites, handling 31 million tonnes shipped with an industry turnover close to 27 billion Euro.

Number of Chemical Distributors

890 880

880 869

870 860 850

838

840

832

830 820 810 800

2010

2011

2012

2013

Number of Employees

32.500

32.158

32.000 31.500

31.035

31.000 30.500

30.498

30.000 29.377

29.500 29.000 28.500 28.000

(*) The substantial drop is primarily caused by the drop in employees in Italy (-2300)

27.500

8 | Fecc Business Plan 2015

2010

2011

2012

2013 *

Fecc 2014 survey (Data 2013)

Breakdown per country on the number of (Seveso) sites and number of employees Total # Seveso Sites

330

314

300

Total # Employees 8.000

7.037

7.000

250

6.000

6.000 4.959

200 150

4.000 3.157

0

3.000

2.600

100 50

5.000

176

166

80 1.059 38 7

B

408 17 10

CH

Total # Sites

50

488 25

800

31 4

CZ

D

28

1.316

12

5

DK

ES

37

F

Total # Seveso Sites

272 22 0

FIN

38

30 13

I

181 1

IRL

2.000 100 1.000 36

9

5

NL

P

35

0

S

1.000 0

UK

Total # Employees

Members Exports (Company Survey) The main non-EU export markets for 2013 are : 1. Turkey 2. Switzerland 3. Russia 4. USA

Export China Export Norway

Export Africa (others) Export Asia (other) Export Ukraine

Export USA

Export Maghreb Others Export Switzerland

Export Turkey

Export Brasil Export South America (others)

Export Russia

Fecc Business Plan 2015 | 9

Fecc 2014 survey (Data 2013)

Members Imports (Company Survey) Figures from 2013 show that the predominant import markets are : 1. China 2. USA 3. South Korea, Asia (other), India

Import Japan Import Taiwan Import Switzerland

Import India Import Asia (other)

Import Turkey Import Thailand

Import South Korea

Others Import Canada Import Brasil

Import USA Import China

In the next two graphs we asked the National Association members to rate (from 1-very low- to 5-very high-) the sectors supplied and the activities of their members.

Sectors supplied & Distributor activities The top five sectors being supplied are : ,,Chemicals ,,Coatings ,,Plastics ,,Cosmetics ,,Paint

100% 90% 80% 70% 60% 50% 40% 30% 20% 10%

10 | Fecc Business Plan 2015

High

Low

Very Low

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Fecc 2014 survey (Data 2013)

The most common activities among the Fecc distributor members remain : ,,Distribution ,,Warehousing ,,Technical

support

100% 90% 80% 70% 60% 50% 40% 30% 20% 10%

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Fecc Business Plan 2015 | 11

International Trade Committee

BTC Europe Chairperson Introduction

The International Trade Committee focuses on issues pertaining to trade with major emerging markets in Asia, South America, Africa, Middle East and Eastern Europe. The Committee focuses not only on exports and imports, but also on issues specific to the chemical distribution sector in these regions.

Activities & Achievements 2014 ,,The

Committee updated members on trade regimes, embargoes and trade defence instruments : ◊ Analysis of various Free Trade Agreements (FTAs) and trade pacts being negotiated. ◊ Monitoring of various embargoes and restrictions for example on, Iran, Syria and Russia amongst others. ,,Fecc Representation at the EuroCommerce International Trade Committee, DG Trade Market Access Working Group on Chemicals, EuroCommerce Exports Working and the EU Russia Regulatory dialogue - subgroup on chemicals. ,,Distributor/agent and principal issues : ◊ The Committee focused on various issues pertaining to distribution agreements. ,,Organised an International Trade meeting on 13 November 2014,

12 | Fecc Business Plan 2015

Fanny Torras – Quimidroga Nathalie Veronelli – Eigenmann & Veronelli Juan Manuel Wilke – Campi y Jove Oliver Zimmermann – TER Group

focusing on embargoes, trade restrictions and distribution agreements. ,,European Commission consultations ◊ Responded/developing a response to the following consultations EEPublic consultation on investment protection and investor-tostate dispute settlement (ISDS) in the Transatlantic Trade and Investment Partnership Agreement (TTIP).

EEA strong European policy to support Small and Medium-sized enterprises (SMEs) and entrepreneurs 2015-2020 – Public consultation on the Small Business Act (SBA).

EEPublic consultation on the Evaluation of the Commercial Agents Directive (86/653/EEC) EEPublic consultation on the Commission’s Stakeholder Consultation guidelines EEPublic consultation on the revision of the Commission’s Impact Assessment guidelines. ◊ Contribute to the European Commission study on the cumulative cost assessment for the chemical industry.

Work Plan 2015 ,,Provision

of information on emerging markets : ◊ Analysis of economic data from different countries and regions

members

Franz Saif

Joel D’Silva – Fecc David Garcia – Barcelonesa Carsten Guentner – NRC Steve Fannin – Omya AG Schweiz Pavel Kratochvil – Barentz Michael Paetzold – IMCD Claus Pedersen – R2 Group Heinrich Schrage – Lanxess Distribution

and providing this to members.

Likely regions and countries include Middle East, South East Asia and China. ◊ Presentations on the economic climate, investment opportunities, access to credits, special programmes, chemical associations and related aspects in emerging markets. ◊ Update members on regulations affecting trade and chemical distribution. ◊ Distribute market studies and other publications available to members. ◊ Organise market focused international trade meetings. ,,Organise chemical trade meetings on a regular basis and attract potential members to attend. ,,Continue work on distributor/agent and principal issues. ,,Continue providing regular updates to members on : ◊ Free Trade Agreements (FTAs) ◊ Anti-dumping investigations and antisubsidy measures ◊ EU regulations on sanctions ◊ Other tariff and non-tariff barriers ,,Monitoring the Russia Round Table discussions and the Customs Union. ,,Participation in DG Trade Market Access Working Group on Chemicals and the EuroCommerce International Trade Committee.

members

SHE Committee

Douglas Leech – CBA (British Association) Vice-Chairperson Ophélie Roblot – Fecc Alain Berthet – BACD (Belgian Association) Henk Boden – Caldic Peter Cooper – Univar Jacques Declercq – BACD (Belgian Association) Ahmed Diboune – Azelis Group Heinz-Werner Dobbertin – VCH (German Association) Virgine Fourneau – Inventec Simona Lai – Omya

Introduction The Safety, Health and Environment (SHE) Committee is an expert group that monitors developments in the areas of safety, health and environment, evaluates critical developments in the legislative process and works closely with relevant stakeholders. Currently, the Committee focuses on the Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), the CLP Regulation, the Seveso Directive and the Biocidal Product Regulation (BPR).

Fecc’s contribution includes joint development of several guidance documents and official responses to consultations. The Committee deals with the implementation of REACH, CLP and Biocides through its involvement in the Partner Expert Groups (PEGs) in charge of developing and updating guidance documents e.g. Guidance on Information Requirements and Chemical Safety Assessment (IR&CSA) : Use Descriptor System, Guidance on Active Substances and Suppliers (Article 95 list) under BPR. The participation in the Director’s Contact Group, at the Competent Authorities on REACH and CLP (CARACAL) and the Expert Network on Exposure Scenarios (ENES) enables Fecc members to be actively represented in the decision making processes of the REACH and CLP implementations.

The SHE Committee provides input via regular contacts with the European Commission, the European Chemical Agency (ECHA) and other industry associations. Fecc is a member of DUCC, the downstream user’s platform and of the REACH Cross Sector Group which puts together representatives

Marianne Lyngsaae – Brenntag Eyck-Michael Poll – Ter Hell Birthe Oldenborg – KB (Danish Association Renato Porta – AssICC (Italian Association) Gilles Richard – UFCC (French Association) Katrin Schindler – C.H. Erbslöh Heinrich Schrage – Lanxess Distribution Jan Skov Norby – R2 Group Peter Steinbach – VCH (German Association) Raoul Tacou – Biesterfeld Steffen Voss – Aug. Hedinger Willem Vriesendorp – VHCP (Dutch Association)

Michael Pätzold IMCD Chairperson

from the entire supply chain in order to resolve registration and authorisation related issues.

Regarding CLP, Fecc plays an active role in taking part in the discussion on the information requirements to Poison Centres and in preparing CLP 2015 deadline for reclassification of mixtures.

Fecc provides advice regarding the implementation of relevant legislations e.g. REACH registration, authorisation and restriction processes, SDS relevant issues, CLP or BPR requirements.

Monitoring relevant issues and updating the members accordingly is part of the SHE Committee’s activities; it focuses for instance on emerging and existing chemicals legislation outside of Europe, on development of IT tools and on enforcement experience.

Other issues of priority include the GHS with the 7th and 8th ATP to CLP, the implementation of the Seveso Directive and several initiatives concerning the safety of chemicals. Fecc actively contributed in the discussion on the reclassification of nitric acid.

Activities & Achievements 2014 REACH ,,Advocate

for the simplification and reduction of the overall costs of REACH registration ,,Registration : ◊ Gathered Fecc’s members intentions with regard to the 2018 registration deadline ,,Exposure Scenarios : ◊ Harmonised format for ES adopted at ENES. The use of the harmonised format will increase clarity and better understanding at all downstream level of the supply chain.

Fecc Business Plan 2015 | 13

SHE Committee

Fecc comments included by ECHA in their webpage on advice on safe use of mixtures for formulators and importers to give more recognition to distributors. ,,Authorisation ◊ Publication of revised joint industry guidance on authorisation together with nine industry associations. ◊ Set up a monthly update system to update Fecc members on the substances included on the registry of intention. ◊ Promoted a simplified authorisation approach for substances used under controlled conditions such as ADCA, DMF etc. ◊

CLP ,,Scientific

advocacy encouraged the European Commission to re-consider nitric acid acute toxicity classification proposal. ,,Fecc/Cefic/Eurometaux/DUCC Workshop : “How to classify MIXTURES under CLP-Be able to check your software results!” 19-20 May, 2014.

Work Plan 2015 General ,,Prepare Fecc’s views and contributions to be communicated to the EU institutions and external stakeholders. ,,Monitor and advice on the REACH, Seveso, CLP and Biocides implementations. ,,Monitor other relevant legislation that has an effect on health, environment or safety, as needed e.g.,worker safety legislation, REACH equivalent in non EU Countries, Industrial Emission Directive (IED), Regulation concerning the placing of plant protection products on the EU market.

REACH ,,Raise awareness among Fecc’s members on the 2018 registration deadline and identify tools and actions to support them. Advocate for the simplification and reduction of the overall costs related to the 2018 registration deadline. ,,Monitor the register of intent for substances proposed for harmonised classification, for SVHC and for restriction.

14 | Fecc Business Plan 2015

,,Member

of the DCG : identify solutions for new issues related to the 2018 registration deadline with a special attention to SMEs and represent distributors’ interests. ,,Provide company members with advice regarding use communication and implementation of Exposure Scenarios. ,,Co-organise the upcoming ENES meetings and participate in the ad hoc working groups. ,,Participation in the development and update of guidance documents (PEGs) ,,Monitor the public consultation regarding substance inclusion on the candidate list, restriction and authorisation annexes. ,,Further investigate and inform members on the issues related to the communication of authorised substances. ,,Monitor enforcement actions at Member State level, identify Members’ issues and discuss with appropriate bodies. ,,Monitor developments related to nanomaterials, endocrine disruptors and polymers.

CLP ,,Raise awareness regarding the 2015 mixture classification deadline and increase relevant knowledge. ,,Continue to follow up the discussion on CLP Article 45 (4) harmonisation of information to Poison Information Centres. ,,Continue to monitor the implementation of GHS within other countries and provide advice accordingly. ,,Actively contribute to the mixture classification methodologies development. ,,Monitor developments in GHS to provide early advise on potential issues ,,Monitor adoption of GHS in other jurisdictions Biocides the Cefic European biocidal product forum ,,Organise a workshop regarding the BPR implementation ,,Monitor development of ‘in-situ’ biocides debate ,,Monitor biocidal active substance approval process ,,Join

members

Responsible Care Committee

Ahmed Diboune – Azelis – Vice-chairperson Jan Thienpont – Fecc Ralph Alberti – VCH (German association) Maria Almenar Martin – Azelis Catarina Carvalho – GROQUIFAR (Portuguese association) Jacques Declercq – BACD (Belgian association) Melanie Gay – UFCC (French association) Vérter Gomes – GROQUIFAR (Portuguese association) Phil Hockaday – Univar Pavel Karas – SCHOD CZ (Czech association) Terhi Kuljukka-Rabb – TKL (Finnish association) Simona Lai – Omya Jakob Lamm Zeuthen – KEMI&LIFE SCIENCE (Danish association) Sjoerd Looijs – Cefic

Introduction Responsible Care (RC) helps the chemical industry globally to operate safely and with care for future generations. Through the sharing of information and a system of checklists, performance indicators, action plans and verification schemes, Responsible Care enables the industry to demonstrate how its health, safety, security and environmental performance has improved over the years. The Responsible Care companies upgrade existing policies and implement new ones to keep up with and exceed an ever changing regulatory environment; the aim is to have continuous improvement in place.

Responsible Care requires companies to be open and transparent with their stakeholders, ranging from local authorities and government to the media and of course the general public whilst maintaining their security commitments.

Activities 2014 Fecc organised four RC Committee meetings in order to establish a platform for RC coordinators and RC managers to interact and share best practices.

During the first half of the year a workgroup was established to revise the Fecc EU RC Programme.

The objective was to : ,,Make

the programme more transparent and consistent ,,Create the possibility to use non-ESAD assessment schemes to increase flexibility of usage of the programme.

Lourdes Luque – AECQ (Spanish association) Marielle Martiny – Solvay Peter Newport – CBA (British association) Marja Ola – TKL (Finnish association) Michael Pätzold – Brenntag Matt Pollock – IACI (Irish association) Renato Porta – AssICC (Italian association) Thomas Puehringer – Brenntag Gilles Richard – UFCC (French Association) Steffen Saecker – SAFECHEM Katrin Schindler – C.H. Erbslöh Patrick Vandenhoecke – Solvay Heinrich Van Megen – Brenntag Wim Vermeylen – BACD (Belgian Association/IMCD) Göran Wall – IKEM (Swedish association) Dorota Zakrzewska – HSH Chemie

Robert Stuyt VHCP (Dutch Association) Chairperson

,,Create

a series of quality criteria’s in order to evaluate the programme and in order to benchmark non-ESAD assessment schemes.

In May, the workgroup finalised the document and the RC Committee was asked to make final comments. The revised programme was sent to Cefic for approval.

With regards to the Fecc EU RC Companies, in 2014 two more companies applied for the programme and we are expecting to receive five more by the end of the year. In total there are now 13 distributor companies in the programme.

Work Plan 2015 Fecc commits to the following RC objectives for 2015 1. Fecc will look into the possibility to promote the programme more intensively towards stakeholders. a. Perform a stakeholder analysis to identify all stakeholders b. Work out a communication programme for promotion of RC based on the clear advantages of implementing an RC programme 2. List and benchmark the existing National Association programmes in order to establish best practices throughout Europe.

3. Set up an internal Fecc workgroup in order to discuss the way forward regarding RC for distributors 4. Set up an internal Fecc workgroup in order to discuss the way forward regarding RC for distributors

Fecc Business Plan 2015 | 15

Responsible Care Committee

Fecc RC survey 2014 RC IMPLEMENTATION * This graph shows that general RC implementation level is increasing year after year. The average level of RC implementation throughout Europe for 2013 is 65.28 % 69%

68%

68% 67%

67%

67%

66% 65% 64% 63% 62%

63% 62%

61% 60% 59% 58%

2009

2010

2011

2012

This second graph shows the implementation in Europe by country and shows the result from 2009 to 2013.

We see an increased implementation level in Denmark, Finland, France, Portugal and Spain.

UK (CBA) S (IKEM) P (GROQUIFAR) NL (VHCP) IRL (IACI) I (AssICC)

A decrease in implementation level can be observed in Sweden and Germany.

FIN (TKL) F (UFCC)

The rest of Europe remains stable at a high level.

ES (AECQ) DK (KEMI&LIFE SCIENCE) D (VCH) CZ (SCHOD)

(*) No data from Switzerland and Austria is available

16 | Fecc Business Plan 2015

2013

2013 2009

B (BACD) 0%

20%

40%

60%

80%

100%

Responsible Care Committee

LTI RATE 2013 (BY COUNTRY) * If we look at the LTI- Rate for 2013 (# Work Accident-with loss of time more than 3 days x 1.000.000/ # worked hours), with an average level for Europe set at 5.47.

13,58

14 13 11,66

12 11

10,11

10 9

7,70

8 7

5,68

6

5,68

5 3,57

4

3,53 2,73

3

2,40

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1,68

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AVERAGE LTI EVOLUTION (2010-2013)

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2010

2011

2012

2013

Fecc Business Plan 2015 | 17

Product Stewardship Committee

IMCD Chairperson

members

Incagli Michèle

Jan Thienpont – Fecc Maria Almenar Martin – Azelis Sébastien Gallet – Cefic/ECSA Véronique Garny – Cefic Simona Lai – Omya Marielle Martiny – Solvay Ferdinand Pree – SAFECHEM

Patrick Vandenhoeke – Solvay Heinrich Van Megen – Brenntag

Introduction

Work Plan 2015

The Product Stewardships (PS) Committee brings together representatives of the chemical distribution industry and the main European chemical manufacturers holding Fecc’s associate membership. The aim is to discuss, develop and coordinate common initiatives on matters that concern the complete life cycle of a product.

Following the workshop on chemicals in the food supply chain, there will be some additional work performed in the form of a guidance document for non-regulated chemicals in food applications.

Every year the Committee members select a hot topic for the distributor community. The complete working year of the Committee is mainly devoted to this issue.

Activities 2014 On September 17, Fecc hosted its second Product Stewardship workshop which focused on Food Safety (Food Safety : How to Comply as a Chemical Distributor”).

The workshop was hosted by Solvay and was a success with about 60 participants.

The workshop saw some very interesting presentations on the following topics : ,,Possible

applications of chemicals in the food industry (Cefic) ,,Existing regulatory Framework and legal repercussions for chemical distributors (Mayer Brown) ,,Quality Standards applicable in the food industry (A+Quality) ,,EU regulatory perspective (DG Sanco) ,,Case studies presented by (Azelis, Univar, A+ Quality)

18 | Fecc Business Plan 2015

End of 2014/beginning of 2015 a new topic will be selected by the Product Stewardship Committee.

This topic will once again serve as a focal point for the PS Committee to work around.

members

GTDP Committee

Catherine Martin – Univar – Vice-chairperson Joel D’Silva – Fecc Ralph Alberti – VCH (German Association) Maria Almenar Martin – Azelis Pauline Ayres – Azelis Franziska Buck – Biesterfeld Anaide Burel – UFCC (French Association) Monica Comajuan – Quimidroga Daniela Fermo – AssICC (Italian Association) Marta Ferrer Monsech – Campi y Jové Ulrike Gerster – Barentz

Introduction The Good Trade and Distribution Practices (GTDP) Committee formulates Fecc’s positions in relation to distribution in sectors such as pharmaceuticals, cosmetics, food and feed. The Committee also facilitates GMP and GDP education for Fecc’s Members by organising technical seminars and conferences on related issues.

Further, the Committee is a stakeholder in relevant meetings and working groups with the European and international regulatory authorities, including the European Medicines Agency (EMA), the European Commission and the European Food Safety Authorities (EFSA).

Activities & achievements 2014 ,,The

Committee closely monitored all activities pertaining to the Directive on falsified medicinal products and communicated this to the members. ◊ The Committee circulated updates, communications and various published reports to the members. ◊ In 2013, the Committee responded to the European Commission consultation on the revision of the guidelines on GMP for Medicinal Products : Part 1 Chapter 5 : Production.

The final version released in 2014 included several of the Committee’s suggestions and comments.

Laszlo Kegl – Forum Products Ltd (Barentz) Douglas Leech – CBA François Minec – Velox Anneliese Neuser – Harke Jan Skov Norby – R2 Group Hanna Puetz – Brenntag Gilles Richard – UFCC (French Association) Stephan Rynka – IMCD Henk-Jan Schuuring – Barentz Christoph Sonntag – Azelis Claudio Zanotto – AssICC (Italian Association)

The Committee further distributed an updated document highlighting the changes and revisions. ◊ Monitored activity pertaining to (a) Guidelines for the risk evaluation for ascertaining the appropriate GMP for pharmaceutical excipients and (b) Guidelines on the principles of GDP for Active substances for medicinal products for human use. ,,Organised a Regulatory and Quality Standards Symposium on March 26, 2014, which was well attended.

Speakers from the European Commission, European associations and law firms, as well as company executives presented and discussed a wide array of issues pertaining to Regulation, Safety and Quality standards in the areas of pharmaceuticals & excipients, food & feed additives and cosmetics. ,,Fecc actively participates in the EXCiPACTTM Certification scheme. ◊ EXCiPACT TM has become a freestanding, not-for-profit association (asbl) under Belgian law. The Articles of the Association were signed on January 29, 2014, in Cannes. ◊ Fecc is a member of EXCiPACT TM asbl and is represented in the Board. Fecc’s representative also acts as EXCiPACTTM treasurer. ◊ EXCiPACT TM certificates have been issued in Canada, France, Germany, The Netherlands, and Saudi Arabia.

Frank Milek Aug. Hedinger GmbH & Co KG Chairperson

Hosts and coordinates EXCiPACTTM training programmes. ,,Contributed to an AT Kearney study on pharmaceutical chemicals distribution ,,Monitoring all relevant legislation and related activities pertaining to Food, Feed and Cosmetic products. The Committee regularly invited members and external experts to make presentations on regulatory updates. ◊

Work Plan 2015 ,,Systematic

monitoring of all developments pertaining to pharmaceutical ingredients and excipients as well as those related to the implementation of the Directive on falsified medicinal products. ,,Continued involvement in the EXCiPACTTM certification scheme. ◊ Actively participate and contribute to the scheme and continued implementation. ◊ Assist and continue supporting EXCiPACTTM training programmes. ◊ Continued cooperation with IPEC, EFCG and other stakeholders. ,,Review and follow up on all regulatory and legislative developments pertaining to pharmaceuticals, Food, Feed and Cosmetics. ,,Organise a training course or symposium on a hot topic based on the objectives of the committee.

Fecc Business Plan 2015 | 19

Precursors Committee members

Ralph Alberti

Jan Thienpont – Fecc Maria Almenar Martin – Azelis Anaïde Burel – UFCC (French Association) Douglas Leech – CBA (British Association) Peter J. C. Newport – CBA (British Association) José M. Plana – Quimidroga S.A.

VHC (German Association) Chairperson Introduction The Precursors Committee is a group of experts that shares information and discusses the latest European and global developments in the fields of drug precursors, explosives precursors, the Chemical, Biological and Radio–Nuclear (CBRNE) Action Plan with focus on the chemical subgroup and Prior Informed Consent Procedure (PIC).

The Committee usually meets three times a year (if there is a need) and has both an active circulation of information and is engaged with increasing frequency in the formulation of Fecc’s positions and technical advocacy.

Activities 2014 2014 was a year with less activity by the European Commission. Fecc therefore organized just one Committee meeting in February 2014. If there is a need for a second Precursors Committee, there will be a conference call organised.

Explosive Precursors Fecc, in association with the CBA, is heavily involved in the Standing Committee on Explosives Precursors (SCEP). The SCEP works on reducing the risk of misuse of certain chemicals to fabricate home-made explosives. The SCEP assists the European Commission in its work to further reduce the risks related to the misuse of such precursors.

The European Commission Action Plan promotes other preventive measures, such as the tightening of security along the entire supply chain of commercial explosives in the EU, including in production, transport, storage, commercialisation and final use. This group has finalised the draft guidance on precursors relating to Regulation (EU)

20 | Fecc Business Plan 2015

No 98/2013, which is now officially published. Its development was monitored by the Committee.

The document in wide parts is based on the known FECC Model Agreement. Of special interest for the distribution sector is its section D, which gives special guidance to the reporting of suspicious transactions, disappearances and thefts according to Art. 9 of the Regulation. There is also a definition when a mixture has to be considered to be an attractive explosive precursor.

Drug Precursors Regulation (EU) No 1259/2013 of the European Parliament and of the Council of November 20, 2013 amending Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Community and third countries in drug precursors and Regulation (EU) No 1258/2013 of the European Parliament and of the Council of November 20, 2013 amending Regulation (EC) No 273/2004 on drug precursors have been published in the Official Journal of the European Union.

The most important changes for chemical distributors are : ,,The

substance “alpha phenylacetoacetonitrile”, better known as APAAN (with CN Code 2926 90 95 and CAS No 4468 48 8) has been scheduled in Category 1 of the Annex to Regulation (EC) No 111/2005. ,,Acetic Anhydride (AA) is included in the new subcategory 2A of Annex I to Regulation (EC) No 273/2004 to allow increased control of its trade. End-users of subcategory 2A substances will have to register. However, this new requirement will only become obligatory as of June 30, 2015

Precursors Committee

,,In

considering whether to grant a license or a registration, the competent authority shall take into account the competence and integrity of the applicant, in particular the absence of any serious infringement or repeated infringements of legislation in the field of drug precursors and the absence of a record of any serious criminal offence. ,,The competent authorities of each Member State shall prohibit the introduction of consignments of non-scheduled substances into the customs territory of the Union or their departure from it where there is sufficient evidence that those substances are intended for the illicit manufacture of narcotic drugs or psychotropic substances. ,,Additionally, each Member State may adopt the measures necessary to enable its competent authorities to control and monitor suspicious transactions involving non-scheduled substances.

Chemical Biological Radiological Nuclear and Explosive (CBRNE ) During 2014, the focus of the CBRNE stakeholder meetings and subgroup meetings was primarily on detection (being the priority policy area) and on the vast amount of projects initiated by the European Commission (+70 projects). Some of the projects will have a very long duration time.

There is an intention to develop Risk Acceptance Criteria (RAC) in the field of security.

World Customs Organisation (WCO ) Global Shield seminar October 2014 The objective of the seminar was to raise awareness, discuss best practices and increase

collaboration between customs administrations and other government agencies in the field of explosive precursor chemicals that can be used for manufacturing IEDs (Improvised Explosive Devices).

Achievements 2014 ,,Promotion

of the Fecc Model Agreement with regards to ICCTA and the WCO.

Work Plan 2015 Fecc commits to the following objectives for 2015 : Explosive Precursors the implementation of the new Regulation on Explosive Precursors ,,Liaise with industry stakeholders in the development of positions and sharing best practices ,,Promote the Fecc Model Agreement where possible ,,Continue monitoring the EXPEDIA project ,,Monitoring

Drug Precursors ,,Continue monitoring the work of the European Commission Drug Precursor Working Group ,,Providing information to the European Commission on the impact of the possible revision of the drug precursors and representing the distributor industry position. ,,Inform members of the pending revisions to the regulations.

CBRNE ,,Broaden and deepen good contact and discussions with the European Commission ,,Continue monitoring and impacting the CBRN Advisory Group and Chemicals sub-group

Fecc Business Plan 2015 | 21

Logistics Committee

CBA (British Association) Chairperson

Jonathan Garlick – BP Peter Steinbach – VCH (German association) Hugo Van der Boom – Lyondell Chemie

Introduction

,,Participation

The Logistics Committee monitors developments in EU and international legislation concerning the safe transport and handling of dangerous goods as well as transport security related issues. Some of the regulations followed by this Committee are : the UN Model Rules, ADR/RID/ IMDG and other issues dealing with the carriage of dangerous goods.

The Committee works directly with relevant industry groups such as CEFIC (European Chemical Industry Council), IRU (International Road Unit) and ECTA (European Chemical Transport Association).

Activities 2014 ,,Fecc

hosted the Logistics Committee twice in 2014. ,,At the UN level Fecc monitors the developments of the UN Subcommittee of Experts for Transport of Dangerous Goods. ,,Participate at the European Commission DG Move meetings on the transport of dangerous goods

22 | Fecc Business Plan 2015

members

Peter J. C. Newport

Jan Thienpont – Fecc Maria Almenar Martin – Azelis Anaide Burel – UFCC (French association) Frank Braeckmans – Exxon Jacques Declerq – BACD – Belgian association Ignace Dejager – Brenntag Serge Dewolf – BACD (Belgian association) Vanessa Garenton – DKSH

in EU Commission LANDSEC meetings, involving security related issues in land transport. ,,Involvement with stakeholders, cooperation and exchange of experiences with relevant international associations (INDA, Cefic, ECTA) ,,The Fecc secretariat participated in the revision of the SQAS Rail Module ,,Fecc promoted the Best Practice Guide for Safe (UN) Loading of Freight Road Vehicles in the newsletter and on the Fecc website.

Achievements 2014 Finalisation and distribution of the Fecc/ECTA/ Cefic Best Practice Guide for Safe (UN) Loading of Freight Road Vehicles.

Work Plan 2015 ,,Implement

an administrative process to handle the vast number of official documents in order to inform the Logistics Committee members in an efficient and pragmatic way ,,Fecc will seek to enhance sector and partner attendance through an interesting agenda and by inviting the transport sector.

ESAD Steering Committee

Robert Stuyt VHCP (Dutch Association) Co-chairperson

Jan Thienpont – Fecc Frank Braeckmans – Exxon Sébastien Gallet – Cefic/ECSA Jonathan Garlick – BP Uta Jensen-Korte – Fecc Peter J. C. Newport – CBA-British association Leo Ruppert – Shell

Peter Steinbach – VCH (German association) Patrick Vandenhoeke – Solvay Hugo Van der Boom – Lyondell Chemie Maayke Van Noort – Dow

CEFIC Co-chairperson

Introduction

Activities & Achievements 2014

The Fecc ESAD Steering Committee operates in partnership with Cefic. The aim is to oversee the ESAD module of the SQAS system and identify then resolve any issues of concern. The Steering Committee is responsible for ensuring the integrity of the ESAD module and encourages the ESAD principles being followed by all involved parties.

,,The Fecc Secretariat has actively been involved in

Activities 2014 ,,Monitor

and input to the revision of the SQAQ ESAD module. ,,Status and progress of the ESAD system ,,Encourage the use of ESAD or equivalent system in the Fecc EU Responsible Care scheme ,,Promotion of the active use of the ESAD scheme by distributors and chemical companies ,,The Committee has considered and decided upon the addition of CSR questions in the ESAD Module ,,Fecc has participated in the revision of several SQAS modules

Victor Trapani

the adoption of a new SQAS RAIL questionnaire, the questionnaire was finalized in July 2014. ,,Complete revision of the ESAD 2011 questionnaire, the questionnaire is now ready for implementation in January 2015. The most predominant changes were : ◊ Integration CSR (Corporate Social Responsibility) based on TfS ◊ Security : the incorporation of enhanced questions addressing EU Commission requirements ◊ Security : Adoption of questions already used in SQAS Transport

Work Plan 2015 ,,Fecc

will promote SQAS/ESAD as the preferred assessment scheme for evaluating the responsible care progression at any given site. ,,Monitoring the assessor accreditation

Fecc Business Plan 2015 | 23

ESAD Steering Committee

Fecc ESAD statistics (data 2013) The two graphs below show the year to year trend of the number of active SQAS assessment reports, generated per module and the number of ESAD consultations on active reports. The last graph gives info on the number of available ESAD assessors per country.

NUMBER OF ESAD REPORTS PER SECTION 140 115

120 98

100

100 91

80

75

72

60 47

44 40

34

33

29

31 20

20 0

(Di) Distributor Standard Activities 2012

2013

(S) Site Assessment

(Cs) Chlorinated Solvents

(F) Food, Cosmetic and Pharma

23

21

(G) Good Trade and Distribution Practices

1/7/13 - 1/7/14

NUMBER OF ESAD REPORTS CONSULTATIONS

1/7/13 1/7/14

207

2013

328

2012

150

2011

284 289

2010

323

2009 294

2008 0

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50

100

150

200

250

300

350

ESAD Steering Committee

NUMBER OF ESAD ASSESSORS PER COUNTRY

GB - 3 FR - 3 IT - 5

AT - 2 BE - 2 FI - 2 PL - 2 CH - 1 CZ - 1

DK - 1 GR - 1 HU - 1

Other - 7

NL - 7

IE - 1 PT - 1 SE - 1 SI - 1

ES - 9

DE - 10

Fecc Business Plan 2015 | 25

Associate members

Company members 2M Holdings Algol Azelis Barentz Biesterfeld Brenntag BTC Speciality Chemical Distribution Caldic Campi y Jové CG Chemikalien C.H. Erbslöh Cornelius Group DKSH Eigenmann & Veronelli Grolman Group Harke Group Aug. Hedinger HSH Chemie

IMCD Group Inventec JSC Ruskhimset Krahn Chemie Lanxess Distribution Nordmann Rassmann Omya Quimidroga Quimitecnica R2 Group SAFECHEM SteraChemicals STOCKMEIER Group Telko Tennants Distribution Ter Group Univar Europe VELOX VWR International

AkzoNobel Chemicals (Until December 2014) BASF Dow Corning Dow Europe Evonik Fuchs Kimya Millchem (From January 2015) Shell Chemicals Europe Solvay SQM Europe Wacker Chemie (Until December 2014)

National Associations Austria

France

Portugal

Wirtschaftskammer Österreich (WKO), Bundesgremium des Handels mit Arzneimitteln, Drogerie- und Parfümeriewaren sowie Chemikalien und Farben

Union Française du Commerce Chimique (UFCC)

Associação de Grossistas de Productos Químicos e Farmacêuticos (GROQUIFAR)

Belgium Belgian Association of Chemical Distributors (BACD)

Germany Verband Chemiehandel (VCH) Ireland Irish Association of Chemicals & Ingredients (IACI)

Denmark Kemi & Life Science (KB) Finland Teknisen Kaupan ja Palveluiden yhdistys (TKL)

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Asociación Española del Comercio Químico (AECQ) Switzerland Scienceindustries (SGCI)

Czech Republic Svaz Chemickych Obchodníku A Distributoru Ceské Republiky (SCHOD CR)

Spain

Italy Associazione Italiana Commercio Chimico (AssICC)

Sweden Innovations- och kemiindustrierna i Sverige (IKEM)

The Netherlands Verbond van Handelaren in Chemische Producten (VHCP)

United Kingdom Chemical Business Association (CBA)

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www.fecc.org European Association of Chemical Distributors (Fecc) Rue du Luxembourg 16B B-1000 Brussels, Belgium Tel : +32.2.679.02.60 Fax : +32.2.672.73.55