After the May 2013 registration deadline for substances in the 100 – 1000 tonnage range, the European Chemicals Agency (ECHA) had three months to perform the completeness checks on all registrations for phase-in substances submitted in the two months before the registration deadline. ECHA granted new REACH registration numbers to 9030 dossiers. Since the registration under REACH is always substance and company specific, this total number of dossiers corresponds to 2998 more substances being registered under REACH. ECHA added these new substances to the dissemination database of registered substances.
In addition, ECHA started to publish the non-confidential information from these dossiers on its website. Registrants submitted 770 testing proposals in 376 registration dossiers. 563 were proposals for testing on animals to satisfy the REACH information requirements listed in Annex IX. ECHA will evaluate all those dossiers which include testing proposals relevant to REACH Annex IX by June 1, 2016. All test proposals which require testing on vertebrate animals will be subject to a public consultation on the ECHA website.
In addition, the Agency received 301 confidentiality requests in 254 dossiers. Most of the claims concerned Safety Data Sheet information covering the name of the company, the registration number and information on the uses of the substance. ECHA will assess all confidentiality claims before accepting or rejecting them. Registrants also have to maintain and update their dossiers after receiving the registration number, for example when new information is available. Registrants should also check their REACH-IT accounts frequently for any communication from ECHA.
Communication in the Supply Chain
Companies that supply registered substances to their EU-based customers (Downstream users) need to include the registration number and exposure scenarios in the EU Safety Data sheets that are to be provided to their customers.
Also, EU Safety Data Sheets require an update in the following cases:
- As soon as the company has new information on the hazards or the risk management measures related to the substance;
- Once an authorisation has been granted or refused;
- Once a restriction has been imposed.
- Registration dossier update
Registrants are obliged to keep their dossiers updated. Some of the reasons to update a registration include a change of the substance composition, the increase of the tonnage band or the availability of additional or new information. The company information and other administrative information also need to be updated. The new information has to be submitted to ECHA without delay. For certain types of updates, a fee is charged by ECHA.
Communication with suppliers
A good functioning communication between suppliers and downstream users in the REACH process ensures that all relevant information is communicated within the supply chain. Downstream users may provide information regarding their uses to their suppliers, at least one year before the relevant registration deadline. This applies mainly for all those substances that will be subject to REACH registration by the next deadline in May 2018. Registrants can then include these uses in their Chemical Safety Assessment (CSA). Suppliers should provide information on the conditions of safe use of hazardous substances to their downstream users. Downstream users may contact their suppliers if the conditions of use that are described do not match their own conditions of use. Downstream users need to inform their supplier in case the recommended risk management measures, either in the EU Safety Data Sheet or in the Exposure Scenarios, are not appropriate. In case Downstream users become aware of new hazard information, they should also inform their immediate suppliers without delay.
Exposure scenarios received from suppliers
Hazardous substances registered under REACH are, in most cases, supplied with an extended Safety Data Sheet (eSDS). An extended Safety Data Sheet includes exposure scenarios that describe how the substance can be used safely to protect the human health and the environment.
When downstream users receive an extended Safety Data Sheet (eSDS), they must check whether the exposure scenarios cover their own uses. They must also check whether the conditions of safe use match the conditions under which they actually use the substance. This includes the foreseeable uses of any mixtures which include the hazardous substance that supplied further down the supply chain.
If the actual uses or the conditions of use are different from those described in the extended Safety Data Sheet, downstream users must take one of the following actions:
- Ask the supplier to include those different uses in their chemical safety assessment and to provide them with a revised exposure scenario;
- Adapt their own activities to match the conditions of safe use determined by the supplier;
- Look for an alternative technical solution and stop the use of the substance in question;
- Find another supplier of the same substance who provides a Safety Data Sheet with an exposure scenario that covers their use;
- Carry out their own downstream user chemical safety assessment.
Downstream users need to implement the conditions of use or complete alternative actions within twelve months of receipt of the EU Safety Data Sheet for a registered substance. Downstream users are advised to document their decisions and actions at all stages.
Downstream user report and chemical safety assessment
In certain cases, downstream users have to report unsupported uses to ECHA. Downstream users may carry out a chemical safety assessment if they use a substance outside the conditions described in the exposure scenario provided by the supplier, or if the use is advised against by the supplier. A downstream user chemical safety assessment needs to address only the uses that are not covered in the received exposure scenarios. There is no requirement to perform a hazard assessment if the downstream user considers the hazard assessment reported in the safety data sheet as appropriate. The chemical safety assessment itself is then documented in a downstream user chemical safety report, which must be completed within twelve months of receipt of the EU Safety Data Sheet for a registered substance, but does not have to be submitted to ECHA. The downstream user should report to ECHA that they intend to prepare a Chemical Safety Report (CSR) within six months.
Downstream users have to report unsupported uses to ECHA six months from receipt of the EU Safety Data Sheet for a substance registered under REACH in the following cases:
- They conduct a Chemical Safety Assessment (CSA) and prepare a Downstream user Chemical Safety Report (CSR). This is not the same as a downstream user report.
- They claim exemptions due to the use of a substance or mixture in a quantity of less than one metric tonne per year, or they use the substance for Process Oriented Research and Development (PPORD).
There is one exception to this requirement. Downstream users do not need to report to ECHA if the quantity of the substance for that particular use is less than one metric tonne per year. The chemical safety report must still be prepared, if the total use by the downstream user is greater than one metric tonne per year. The report should contain a brief general description of the downstream user’s use and conditions of use. It should also include a proposal for tests if testing on vertebrate animals is necessary to complete the downstream user chemical safety assessment, and the substance is used in a total quantity of one tonne or more per year.
REACH Article 38(4) states that “a downstream user shall report to ECHA if his classification of a substance is different to that of his supplier”. This refers to all of the downstream users suppliers.
Downstream users do not need to report to ECHA as long as their classification is the same as one or more of their suppliers. But, if they generate a completely new classification, they shall report to ECHA. Downstream users are exempt from reporting to ECHA if they use the substance or mixture in a total quantity of less than one metric tonne per year.
Authorisation and Restriction
Under the REACH Regulation, an EU Member State, or ECHA (on request of the Commission), may propose a substance to be identified as a Substance of Very High Concern (SVHC). After the identification as a SVHC, a substance may be included in the Authorisation list (REACH Annex XIV) and become subject to authorisation. If an SVHC is placed on the Authorisation list, companies may send an application to ECHA requesting the authorisation for specified uses. Registrants and Downstream users shall always pay attention to on-going discussions regarding substances of concern and take pro-active steps regarding authorization of a substance or replacement of the substance in their products. Once a substance is listed on REACH Annex XIV or on the Candidate list, suppliers have to communicate the presence of these substances to their Downstream users. If a chemical poses an unacceptable risk that needs to be addressed on an EU-wide basis, an EU Member State or ECHA (on request of the Commission) may propose a restriction on the manufacturing, placing on the market or the use of that particular chemical of concern. Restrictions (REACH Annex XVII) limit or ban the manufacture, placing on the market or use of certain substances that pose an unacceptable risk to human health and the environment. In case a substance is added to REACH Annex XVII after the submission of the registration dossier and the supply of the Safety Data Sheet to the EU-based customers, the supplier is obliged to communicate the new restriction to his EU-based customers. In most cases this will trigger an update of the EU Safety Data Sheet.
Second REACH enforcement project report published
ECHA’s second enforcement project (REF-2) focused on checking the compliance of downstream users – mainly formulators of mixtures – with the requirements of the REACH and CLP Regulations. REF-2 was carried out in 29 Member States or EEA countries.
The project took place from May 2011 until March 2012. The national enforcement authorities inspected 1181 companies covering 6900 substances, 4500 mixtures and 4500 EU Safety Data Sheets. The larger portion of the inspected companies were small or medium-sized enterprises (SMEs). More than half of the inspected companies were not only active as downstream users but also in additional roles, e.g.; as manufacturers, importers, distributors and only representatives.
The findings showed that 67% of the inspected companies were non-compliant with one or more requirements of the REACH or CLP Regulations. Non-compliance was mostly related to non-compliance with (pre-)registration (REACH, 8%), C&L notification (CLP, 15%), failure to keep and record information (20%) and having wrong or missing risk management measures (12%). The good news is that only 3% of companies failed to have the SDSs on site. But, 52% of the inspected EU Safety Data Sheets showed deficiencies.
The quality of the EU Safety Data Sheets and compliance with the C&L notification and REACH registration obligations need to improve. Manufacturers and importers need to improve their knowledge and execution of the REACH and CLP requirements. The chemical industry needs to increase its EU Safety Data Sheet stewardship to establish compliance and to avoid disruptions in their supply chains. The third REACH and CLP Enforcement project (REF-3) is on its way.
ECHA Dissemination database – Registered substances:
ECHA Classification & Labelling Inventory:
ECHA Candidate list of Substances of Very High Concern:
ECHA REACH Enforcement project:
ECHA Evaluation decisions
ECHA Evaluation webpages:
ECHA Recommendation for inclusion in the Authorisation List
ECHA Enforcement webpage: