REACH in more detail
Consortia
Downstream users

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REACH in more detail

After nearly a decade of intensive lobbying and review, the REACH (Registration, Evaluation and Authorisation of CHemicals) Regulation was formally adopted by the Council of European Environment Ministers on 13 December 2006 and entered into force on 1st June 2007. The aim of REACH is to improve the protection of human health and the environment through the better and earlier identification of the properties of chemical substances whilst, at the same time, enhancing the innovative capability and competitiveness of the EU chemicals industry.

REACH has a very wide scope. It applies to all chemical substances, including metals, which are manufactured, imported, placed on the market or used within the European Community, either on their own, in a preparation (such as an alloy) or in an article. It has implications for producers, importers, formulators, distributors and users of chemicals, as well as those producing and/or importing articles. REACH is based on the idea that industry itself is best placed to ensure that the substances it manufactures and puts on the market in the EU do not adversely affect human health or the environment.

This Table summarises the standard information requirements for registration of substance.

Registration, Evaluation and Authorisation of CHemicals 

Registration: requires industry to obtain relevant information on chemical substances (including metals) produced or supplied to the EU market in quantities of 1 and more tonnes per year. It involves submitting a technical dossier to the Agency containing information on physico-chemical properties of the substance and guidance on how to use the substance safely. Quantities starting at 10 tonnes additionally require submission of a Chemical Safety Report (CSR) to document the hazard classification of a substance. It involves carrying out an in-depth Chemical Safety Assessment (CSA) in order to demonstrate that the level of eventual risk they might pose to the environment or humans is acceptable. Quantities produced or supplied at 1000 tonnes and above are priority substances for this assessment. The information is to be shared between manufacturers and importers of the same chemical (to cut down on redundant testing) and also with ‘downstream users’ of chemicals (to ensure any hazards and risks are managed effectively through the supply chain).

The passage of information up and down the supply chain is a key feature of REACH. Users should be able to understand what manufacturers and importers know about the dangers involved in using chemicals and how to control risks. However, in order for suppliers to be able to assess these risks they need information from the downstream users about how they are used. REACH provides a framework in which information can be passed both up and down supply chains.

Evaluation: is undertaken by the EU Chemicals Agency to assess the testing proposals put forward by industry or to check compliance with the registration requirements. The Agency will also coordinate substance evaluation by the authorities to investigate chemicals with perceived risks. The Agency will publish a list containing such candidate substances.

Substances with properties of very high concern will additionally require authorisation; which will only be granted if the applicant can demonstrate that the risk from use is adequately controlled or that the socio-economic benefits outweigh the risk. Applicants must also analyse whether there are safer suitable alternative substances or technologies which would be possible for substitution. If there are none, REACH encourages the research and development of such substances or technologies for future use. If suitable substitutes become available The Commission may amend or withdraw any authorisation.

REACH allows restrictions on the marketing and use of substances to be agreed at Community level where there is an unacceptable risk to human health and the environment arising from the manufacture, use or placing on the market of the substance.

Pre-registration and SIEF formation

It is estimated that there are around 30,000 substances on the European Market in quantities of 1 tonne or more per year. Registering all of these at once would be a huge task for both industry and regulators. To overcome this, the registration of those substances already being manufactured or supplied is to take place in three phases. These phases are spread over 11 years. To benefit from these provisions manufacturers or suppliers should pre-register their substances between 1st June to 30th November 2008.

Once pre-registered the European Chemicals Agency will identify who is intending to register the same substance and put them in contact with each other. The potential registrants can then come together and form a 'Substance Information Exchange Forum' (SIEF) where they can negotiate sharing their available data and the costs of any generating any new data.

Failure to pre-register by the deadline will mean the substance must be fully registered straight away. Until registration is complete all production and distribution must be terminated.

A general guidance sheet regarding information required for the pre-registration of tin metal is now available; ‘Guidance Sheet for the Pre-Registration of Tin Metal under REACH’ Any company wishing to share and reduce costs of REACH registration of tin metal or inorganic compounds may also like to contact ITRI for information on the relevant REACH Consortia (environment@itri.co.uk). 

Eurometaux and ICMM have also published two guides to assist companies producing metal, metal compounds and alloys to meet their pre-registration obligations under REACH:

1) The requirements for pre-registration - outlining the requirements and process for completing the pre-registration process for substances.

2) The specific requirements for pre-registration (and subsequent registration) of alloys - this leaflet provides additional information on how to deal with alloys and their constituent substances. 
 

Consortia

Whilst not a mandatory requirement of REACH, consortia are the most efficient means of achieving the required levels of co-operation to comply with the REACH objectives and are a valuable tool for manufacturers and/or importers to guarantee that their business interests remain protected.

REACH obligations for joint submission and data sharing lead to the conclusion that REACH compliance is not possible without co-operation among manufacturers and/or importers of the same substance. REACH, however, does not provide detailed rules for such co-operation. The attainment of REACH objectives will therefore depend entirely on the manner in which the industry organises itself. A consortium agreement can have a number of positive effects, such as clear membership rules, control over costs, reduced labour intensity and also provide a means of choosing best quality studies, whilst protecting confidential information. The consortium members may also determine the degree of flexibility they will encounter when preparing the registration dossier for the selected substances. The consortium agreement is therefore a convenient tool for organising compliance with REACH obligations whilst at the same time safeguarding the essential business interests of the participating companies.

Further information on the formation of a REACH Consortium can  be found in this presentation.

The tin metal consortia is now finalised- if you would like a copy of the Agreement, please contact Kay Nimmo (kay.nimmo@itri.co.uk).  

We are also facilitating the formation of separate consortia for inorganic tin chemicals. For more information please contact Katie Hill (katie.hill@itri.co.uk).


Downstream Users

A downstream user is defined as “any natural or legal person established within the community, other than the manufacturer or the importer, who uses a substance, either on its own or in a preparation, in the course of his industrial or professional activities.” Downstream users may be formulators of preparations (eg alloys), users of substances (including metals) in industrial processes, professional users, or producers of articles. Distributors and consumers are not regarded as downstream users under REACH although the Regulation does place a duty on distributors to communicate safety information along the supply chain in the form of Safety Data Sheets (SDS).

Under REACH downstream users are required to inform suppliers of the ‘identified uses’ it wishes to have covered in the Chemical Safety Report (CSR). The manufacturers should then include these identified uses in the exposure scenarios which are annexed to the SDS. An exposure scenario is based on a set of conditions which describe how the substance is made or used, it must include the appropriate risk management measures (RMM) and operational conditions that, when properly implemented, ensure that the risk from the substance is adequately controlled. The downstream user should provide sufficient information to enable the manufacturer to develop relevant exposure scenarios. The downstream user has a duty to implement the RMM and operational conditions specified by the manufacturer.

Alternatively, a downstream user can perform its own Chemical Safety Report (CSR) for “non-identified uses”. It must then separately notify these uses to the European Chemicals Agency (ECA). In this way, a downstream user can choose to keep its use of a substance confidential or decide to use a substance outside the conditions described in an exposure scenario communicated in a SDS. A downstream user CSR consists of developing the exposure scenarios for their intended uses and, if necessary, a refinement of the supplier’s hazard assessment. In addition, it must also prepare an SDS with the exposure scenario as an annex for further downstream users.

If your process is not covered in the CSR then you are not covered and should terminate the process until it is included. The substance and the use must be included in the CSR to continue production.

If you would like to make your use of tin known to us, to be included in the CSR for tin metal, (this may include its use in the production of a tin containing substance) then please contact katie.hill@itri.co.uk   

The European Chemicals Bureau has published some early guidance for downstream users to help downstream user firms begin preparations for compliance with the law. The guidance details how downstream users should prepare for REACH and provides information on the obligations and duties they are subject to under the new Regulation. It urges DU to begin communicating with supplier firms as soon as possible to ensure that the substances they use are registered and remain on the market.

A draft version of the first two chapters of the downstream user guidance document can be found on the European Chemicals Bureau website (http://ecb.jrc.it, see links below). This will be supplemented by more detailed advice early next year.

Guidance for Downstream Users Section 2 – Roles and obligations (external weblink)

Guidance for Downstream Users Section 3 – Preparing for REACH (external weblink)

If you require further information, or would like to discuss your requirements as a downstream user under REACH, please contact katie.hill@itri.co.uk.