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ASSOCIATION As the voice of the European chemical distribution industry, Fecc has plenty of matters to attend to, whether in terms of promoting REACH compliance or dealing with the changing sands of international trade
The European Association of Chemical Distributors (Fecc) has outlined a number of ‘hot topics’ it sees as being of major importance to both the Association and the sector as a whole. In terms of the EU's Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation, for example, Fecc identifies the design, provision and implementation of extended safety data sheets (SDSs) as having become a critical issue. "Even if there is an obligation to add exposure scenarios (ESs) to the SDS of hazardous substances under certain conditions, many of these have either not been supplied or distributors are unable to read and implement them," it says.
Furthermore, the late publication of Guidance documents and the absence of a format for the ESs has lead manufacturers and importers to develop their own IT tools to support the supply of extended SDSs. "ESs are extensive documents, which aim at demonstrating the safe use of substances and sharing information on use and exposure up and down the supply chain. Fecc has undertaken various initiatives to face this issue: to this end Fecc, as part of the Downstream Users of Chemicals Coordination (DUCC) group, is working in the industry-led ESCom XML group, which has developed a data exchange standard to facilitate the flow of information along the supply chain, including standardised phrases," it continues, noting that the European Chemical Industry Council (Cefic) "is also part of this initiative".
"Fecc is involved in the Exchange network on ES (ENES), a cross-sector collaborative network where knowledge, techniques and approaches on building and applying REACH exposure scenarios are shared. The first meeting was organised in November 2011, in which topics for further work were identified: the development of realistic Risk Management Measures (RMMs), scaling, ES for mixtures and the mobilisation of 2013 Substance Information Exchange Fora (SIEFs)," it says. Meanwhile, Fecc is also a member of the industry platform on supply chain communication, which brings together manufacturers, distributors, DU-formulators and article manufacturers. The aim of this, Fecc explains, is for industry to proactively discuss issues related to the registration and supply of critical substances as well as authorisation.
Another key issue stemming from REACH concerns the fast approaching May 31, 2013 deadline for submitting registration dossiers. "Some of our members are preparing for this deadline, although a smaller than expected number of our members is planning to register substances this time around," Fecc says. "Most probably, the June 2018 (1 tonne) deadline will bring many more substances and companies into REACH. Both the 2013 and 2018 deadlines will be challenging, especially for the smaller companies and distributors involved, who are less experienced in working together."
Consequently, cost sharing and the formation of SIEFs remain "major issues" for the coming deadlines. "As some SIEFs may not yet be in place, SMEs might even have to take the lead," Fecc warns. "The reporting of uses is also a matter of concern for distributors. Indeed, the exercise is quite challenging for them as both their uses and the uses of all the DUs down the chain have to be pass up the supply chain." A key message is that registrants for 2013 "have to start the registration process by entering in contact with SIEFs". As such, industry is advised to make available resources and manpower to prepare for the next deadlines and to update their already submitted registration dossier(s).
Regarding the ongoing REACH Review, Fecc notes that it will specifically address the following issues as required by REACH and the Classification, Labelling and Packaging (CLP) Regulation:
• member states' reports on the operation of REACH (Art 117.1);
• the ECHA report on the operation of REACH (Art 117.2);
• alternative test methods (Arts 117.3 and 117.4);
• a review of requirements for registrations of 1 to 10 tonnes (Art 138.4);
• a CLP element (Art 46.2 CLP Regulations);
• a review of ECHA (Art 75.2); and
• a review of the scope of REACH (Art 138.6).
"The Commission intends to publish a Review Communication of 12 pages and detailed background documents," Fecc says. "The Commission will host a conference on September 24 to present the outcome of the review and launch a debate on conclusions and recommendations with the parliament, the council, member states and all other stakeholders. Fecc considers that even though REACH has some weaknesses, it provides a new legal framework for which experience still needs to be gained. Therefore we support a review process with no changes in the current legal text."
C&L and Seveso
On the subject of Classification and Labelling (C&L) Inventory, meanwhile, Fecc notes that on January 3 last year more than 3m notifications of classification were received for more than 107,000 substances. "The dissemination platform," it says, "has shown that multiple classifications have been sent in for the same substance. Different impurity profiles or different forms of the same substance are not explaining all observed differences. Industry should try its best to at least check the notifications – of already registered substances – and clean up the data base."
Turning to the Seveso directive, it states: "The Committee of Permanent Representatives endorsed the compromise proposal agreed between the Council and the European Parliament regarding the directive on the control of major accident hazards involving dangerous substances (Seveso). The formal adoption of the revision is foreseen by the end of 2012. The EU Commission presented its proposal for the revision of the Directive in December 2010. The European Parliament will most probably adopt its position on first reading by June 2012 and the Council will adopt it in the second half of 2012. The new provisions will be applicable by 2015."
The new directive, it continues, addresses the alignment of Annex I (defining the substances falling within the scope of the directive) and the classification of dangerous substances; the adaptation of Annex I to deal with situations occurring after the alignment where substances are included/excluded that do/do not present a major-accident hazard; the provisions relating to public access to safety information; and the introduction of stricter standards for inspections of installations to ensure the effective implementation and enforcement of safety rules.
Another hot topic concerns Responsible Care (RC). "The Fecc European RC Programme is tailor-made for distributors and establishes a harmonised European approach for RC implementation," the Association says, adding that the programme's core principles are based on the eight guiding principles of the International Council of Chemical Trade Associations (ICCTA):
(a) to conform to all legal regulations and requirements and operate in accordance with both government and industry codes of practice and guidance associated with their chemical activities;
(b) to ensure that their activities do not present an unacceptable level of risk to employees, contractors, customers, the public or the environment;
(c) to have written documentation, which covers their activities, and ensure that their health, safety and environmental policies reflect their commitment to the Joint Responsible Distribution/Responsible Care Programme as an integral part of their business strategy;
(d) to provide relevant health, safety and environmental information on company products and activities to employees, contractors, customers, statutory bodies and the public;
(e) to ensure that all employees are aware of their commitment and provide the training necessary to enable them to be involved in the achievement of health, safety and environmental objectives;
(f) to establish and maintain an appropriate emergency response system;
(g) to support and participate in those activities that will improve the quality of their own operations and strengthen health, safety and environmental consciousness and awareness; and
(h) to maintain an awareness of and respond to community concerns that relate to their activities.
"The past year has been an excellent and record breaking year regarding applications received from mainly companies in new member states to join the Fecc European RC Programme," the Association states, revealing that a total of 16 such applications were received. "The applications to join the Fecc European RC Programme from CH Erbsloh (Austria, Poland and Switzerland) and from Azelis (Turkey) received the authorisation from the RC Committee in June 2011 to use the RC logo on a temporary basis until a Third Party Verification (TPV) is scheduled."
"The RC Committee that took place in December 2011 gave the authorisation to use the RC logo on a temporary basis to Azelis (Ukraine, Latvia, Russia, Hungary, Romania, Croatia, Greece, Norway, Denmark and Switzerland) and HSH Chemie (Hungary and Romania). We have already received this year the first applications to the Fecc RC Programme from several Fecc company members and their subsidiaries. The yearly RC report will be approved at the last committee of the year, where a complete overview of the companies that have applied to join the programme will be provided," it says.
"Responsible Care is one of the main priorities for Fecc. The Fecc secretariat has been working with different national associations in the implementation of RC and the improvement of data reporting. The Fecc secretariat visited the Spanish National Association of Chemical Distributors (AECQ) in order to discuss and settle a new RC Programme in Spain for distributors based on the Fecc RC Programme. Work is ongoing and the official launch of their new RC Programme will soon take place," Fecc says. Meanwhile, Fecc is also collaborating with the Portuguese National Distributors Association (Groquifar) with regard to developing a bespoke RC Programme for distributors there based on the existing Fecc RC Programme.
"Fecc also visited the Austrian Federation of Chemical Distributors (WKO) to seek solutions to improve RC participation in Austria," it continues. At the same time, Fecc was also invited by the Swedish National Association (P&K) to participate in the first P&K workshop organised exclusively for distributors. The conference's objective, Fecc says, was to further expand P&K members' knowledge of both RC and the Safety and Quality Assessment System (SQAS) Distributor/European Single Assessment Document (ESAD) 2011.
An ideal tool
"SQAS Distributor/ESAD 2011 is an ideal tool to assess the quality, safety and environmental management systems of chemical distributors," Fecc asserts. "Based on the eight guiding principles of ICCTA, the SQAS Distributor/ESAD 2011 perfectly aligns with the Responsible Care Programme. Carried out in a uniform manner by independent assessors using a standardised questionnaire, the assessment avoids the costly practice of multiple audits by different suppliers."
"SQAS Distributor/ESAD was reviewed during the past two years and SQAS/ESAD 2011 was re-launched in April 2011. After a transition period of three months, only SQAS 2011 can be use since July 1, 2011," Fecc continues. Pointing out that all pertinent information and documentation is available in English, German, Spanish, French, Italian and Dutch, the Association reports that "all the assessors went through a re-training and re-accreditation process during the first semester of 2011".
"Product Stewardship (PS)," Fecc says, "is Responsible Care applied to products. The Fecc PS Committee has been working in the redraft of the PS Guidelines, in collaboration with representatives from the European chemical distributor community and the main European chemical manufacturers holding Fecc membership and in cooperation with Cefic."
On the subject of logistics, Fecc explains that its Logistics Committee monitors developments in EU and international legislation concerning the safe transport and handling of dangerous goods as well as related security issues. "The Committee works directly with relevant industry groups dealing with similar issues. The Fecc Logistics Committee is collaborating with the European Chemical Transport Association (ECTA) in the writing of best practice guidelines to reduce the risks from working at height in the chemical logistics sector. Already at a very advanced stage, the Best Practice Guidelines for the safe working at height in the logistics supply chain and allied sectors should be suitable for all locations, including terminals, ports and cleaning stations."
The main chapters of the draft guidance are:
- Roles and Responsibilities, which provides a clear definition of the roles and responsibilities of the loading and unloading sites and logistics service providers (LSPs);
- Legal Requirements, which covers current applicable legislation, such as the European Directive on working at height, and the consequences of non-compliance for companies;
- EU-OSHA Statistics, which emphasises the risks of working at height and explains why more needs to be done to improve the situation; and
- Risk Assessment – Severity Risk Matrix and How to Conduct a Risk Assessment, which feature a risk assessment flowchart to guide the reader through the process of assessing risks and identifying appropriate solutions.
The Guidance, Fecc asserts, "will be complemented with real examples in order to demonstrate practical approaches and solutions already applied".
Attention to precursors
The Fecc Precursors Committee continues to monitor and influence the development of the draft Regulation on explosive precursors in the European Parliament and Council, the Drug Precursors working group and the Prior Information Consent (PIC) working group. Regarding the Chemical, Biological, and Radiological-Nuclear (CBRN) Advisory Group and Chemical Subgroup, Fecc reports that it "has been present in all the meetings hosted by the European Commission" and has also provided feedback to the Consultants concerning the CBRN Action Plan and the studies related to the implementation of the Plan.
Examples of this include a study on the availability of high-risk chemicals to the general public and in particular to the specific risks associated with the trading of chemicals over internet; a stocktaking study of good practices in CBRN transport security; and a study on the identification of good practices with regard to dialogue between facility security managers and law enforcement, including the topic of providing security advice.
Fecc has also been highly involved with the development of EXCiPACT™, a certification scheme for pharmaceutical excipient manufacturers and distributors. "EXCiPACT," Fecc explains, "is a voluntary international scheme to provide for the independent third-party certification of manufacturers, suppliers and distributors of pharmaceutical excipients worldwide. It will ensure patient safety through supplier quality while minimising the overall costs for assessing the excipient supply chain."
"Fecc," it continues, "is involved as a member of the Global Steering Committee and the Communications/Marketing Committee in the EXCIPACT certification scheme project. Fecc is an important stakeholders engaged in development of this project along with the European Fine Chemical Group (EFCG), the International Pharmaceutical Excipients Council (IPEC) Europe, IPEC Americas and the Pharmaceutical Quality Group (PQG)." EXCiPACT, it notes, "will become an independent legal entity constructed as a non-profit organisation based in Brussels".
"EXCiPACT will ensure cGMP and cGDP requirements are applied to pharmaceutical excipients through a recognised auditing and certification process, thereby increasing safety and reliability as well as transparency of the pharmaceutical supply chain," Fecc asserts. "The certification scheme will provide a cost-efficient method for ensuring that cGMP and cGDP are applied throughout the pharmaceutical supply chain by reducing the audit burden."
"The vision of EXCiPACT," it reports, "is to be recognised as the pharmaceutical excipient manufacturing and distribution certification body and its services will include oversight of pharmaceutical excipients manufacturer and distributor certification; auditor competency development and qualification; a public website with status of information; and an analysis of pharmaceutical excipient manufacturer/distributor compliance." EXCiPACT was launched in January 2012 in Barcelona and the first auditor training programmes were conducted in January in Paris. The second round of auditor training programmes are scheduled to be held at the Fecc Secretariat in Brussels this coming July.
International trade is another issue very close to hearts and minds of members. Consequently, the Fecc International Trade Committee (ITC) regularly follows and updates its members on developments relating to trade agreements and trade pacts. "In particular, the ITC has been following the India-EU trade pact. Besides this, regular updates on EU trade policy, tariffs and trade barrier strategies are also provided to members."
Likewise, the ITC "regularly updates its members on anti-dumping and anti-subsidy measures either in force, under current investigation, terminated or expired," with recent examples having included the imposing of a definitive anti-dumping duty on imports of tartaric acid originating from the People's Republic of China. The ITC also provides member with regularly updates concerning trade embargoes imposed by the EU, such as those on "Iran, Syria and other North African countries experiencing civil and political upheaval".
"The International Trade Committee (ITC)," Fecc states, "is particularly focused on emerging markets and regularly reviews and disseminates factsheets regarding the chemicals sector in the focus regions and related macro-economic data. The regions focused on so far have included (a) the Maghreb region, in particular Morocco, Tunisia, Algeria and Libya; (b) Turkey; and (c) the East European chemicals sector."
More information on many of the topics discussed here can be found on Fecc’s website, www.fecc.org.
The July issue of the Bulletin will include a full report on the Fecc Congress held in Lisbon this past May.