by Tatjana Benko
Key elements of REACH are registration, evaluation and regulatory risk management. Authorisation, restriction and harmonised classification are the regulatory risk management measures processes included in REACH. Communication in the supply chain is the vital element for the safe use of chemicals.
Q: Who are the relevant actors inside of one company in the REACH supply chain?
A: One company may have multiple roles in the REACH supply chain. Depending on a company’s activities and size, possible roles for a company can be manufacturer, importer, downstream user (formulator, manufacturers of articles, end-user, re-fillers, re-importers and certain importers) and distributor.
Q: Who are downstream users?
A: Downstream users are companies or individuals within the European Union (EU) who use a substance, either on its own or in mixture in industrial or professional activities. Under REACH, “use” is almost any activity carried out with the substance as such or in mixture. Use means any processing, formulation, consumption, storage, keeping, treatment, filling into containers, transfer from one container to another, mixing, production of an article or any other utilization. Regarding these activities, downstream users are grouped accordingly. For example, formulators use the substance and add to it to produce a mixture/polymer which is then placed back on the market. Manufacturers of articles incorporate substances or mixtures into articles (both components and finished goods). Re-fillers transfer substances or mixtures from one container to another. A re-importer imports a substance, on its own or in a mixture, which was originally produced in the EU, and the substance was registered by someone in the same supply chain.
Q: What is a special role of importers with ‘only representative’ role? Are they downstream users?
A: Yes, importers with an “only representative” role are downstream users. They import a substance from outside the EU and they are nominated by a non-EU supplier. It is very important to understand who will carry the costs of registration (importer/supplier). When an only representative is appointed, the EU importers within the same supply chain are relieved of their registration obligations and they are regarded as downstream users.
Q: Who are distributors and consumers in the supply chain? Are they downstream users or not?
A: Distributors and Consumers are not downstream users. Distributors take a substance from a manufacturer or importer and supply it to another actor in the supply chain (manufacturer/importer or downstream user). Consumers do not have any obligation under REACH.
Q: Who are suppliers in the REACH supply chain?
A: Suppliers can be any manufacturer, importer or downstream user or distributor who places on the market a substance, on its own or in a mixture.
Q: Who is responsible for the safe use of the substances under the REACH supply chain?
A: REACH Regulation moves responsibility to industry to demonstrate safe use of the substances. Industry is required to generate/evaluate substance data and assess exposure associated with each identified use of the substance. Appropriate risk management measures need to be agreed upon between suppliers and downstream users. Downstream users are required to identify the use of each substance and ensure it is communicated up the supply chain. Communication up and down the supply chain should be facilitated.
Q: What obligation and role do registrants have in the REACH supply chain?
A: Registrants (manufacturer/importer) in the supply chain communication must:
- register each substance manufactured or imported in a quantity >1 tonne per annum (tpa). Some substances are exempted from registration, according to annexes IV and V of REACH, polymers, articles.
- prepare a chemical safety assessment (CSA) and to document this assessment in their chemical safety report (CSR) for substances that are manufactured or imported in quantities of more than 10 tonnes per year.
- prepare the safety data sheet with exposure scenario (when required). Safety data sheets (SDSs) have been a well-accepted and effective method for the provision of information in the supply chain to allow safe use of substances and mixtures.
Q: What obligation and role do downstream users have in supply chain communication?
A: Firstly, downstream users should check exposure scenarios to ensure the use is covered. If their use is not covered then the downstream user has to take one of the following actions:
- change condition of use or
- contact the supplier to include the additional (unsupported) use in their CSR or
- select an alternative supplier or
- prepare and submit a downstream user chemical safety report for unsupported uses (DU must report to ECHA within 6 months)
Downstream users need to check that substances are manufactured or used in line with any restrictions or authorisations which may apply. If a substance of very high concern (SVHC) is incorporated in articles above 0.1% w/w, downstream users may need to notify ECHA or inform customers regarding safe use.
Any actor in the supply chain who is required to carry out a chemical safety assessment for a substance shall ensure that the information in the safety data sheet is consistent with the information in this assessment.
REGULATION (EC) No 1907/2006 – Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH):
Guidance for downstream users: http://echa.europa.eu/documents/10162/13634/du_en.pdf
Product Stewardship in the Supply Chain: http://www.cefic.org/Documents/IndustrySupport/RC%20tools%20for%20SMEs/Document%20Tool%20Box/Product-Stewardship-in-the-Supply-Chain-2012.pdf?epslanguage=en