UBA in the REACH process

German chemicals legislation appoints UBA as the responsible authority for environment under REACH. UBA has therefore become the competent body for the assessment of environmental risks associated with chemicals. The Federal Institute for Risk Assessment (BfR) is the authority responsible for consumer protection in Germany, and occupational safety is in the remit of the Federal Institute for Occupational Safety and Health (BAuA). In addition to evaluating submitted information, UBA is in charge of identifying substances whose manufacture or application requires regulation due to their impact on the environment or certain intrinsic properties. Another important task is to support REACH stakeholders in the fulfilment of their obligations. UBA is also involved in the further development of chemical safety evaluation methods. The state of knowledge in science must be integrated whilst doing justice to the precautionary principle. Finally, UBA makes proposals on the further development of the REACH Regulation and introduces them to the discussion process at EU level. The scope of UBA’s work also includes commissioning research projects or expert reports to third parties. UBA staff members sit on a number of different REACH committees, including the committee on risk assessment and the socio-economic analysis committee, which drafts statements on planned restrictions, authorisations and classifications.

UBA has drafted a number of proposals for the further development of REACH. The following is only an extract of some of these very detailed suggestions. Essentially, UBA is calling for a maximum of REACH information to be made available to the public without compromising the justified interest of the registrants. Information must be processed by ECHA in such a way as to ensure maximum transparency.

Registration, chemical safety assessment

• REACH must adopt specific requirements for nanomaterials.
• The standard information requirements must also apply for registration of new substances that are manufactured / imported at volumes of 1-10 tonnes per year.
• The quality of registration dossiers must be improved through evaluation of more dossiers and by introducing appropriate legal consequences in case of low quality dossiers (e.g. revocation of registration).
• Every processor or downstream user of a substance must be unmistakably obligated to check whether his intended applications of the substance are included in an existing registration – that is, whether or not they are safe.
• Provisions governing safety assessment of chemical mixtures must be substantiated.
• REACH guidelines must define methods of risk assessment for inputs of chemicals from diffuse sources.

Authorisation

• There must be a shift of the burden of proof in identifying Substances of Very High Concern. If there are grounds to suspect that a substance has properties of very high concern, the registrant must refute this concern within a reasonable period of time. If he cannot disprove the concern the substance is identified as a Substance of Very High Concern.
• Manufacturers and importers who apply for authorisation of a Substance of Very High Concern should generally submit a substitution plan for this chemical.
• Any exemptions from the procedure to authorise Substances of Very High Concern must be reviewed, especially as concerns the provisions  governing articles and intermediates. Mandatory authorisation should be extended to imported articles which contain substances subject to authorisation under REACH (> 0.1% w/w).

Information on chemicals in articles

• The information disclosure requirements concerning Substances of Very High Concern in articles should also apply to article components that contain more than 0.1 per cent by weight of an SVHC.
• A binding format of information supply about chemicals in articles should be introduced along the supply chain. In this format other hazardous substances used in the article should also be specified.
• For consumer information purposes the label/packaging of articles must indicate which Substances of Very High Concern and other hazardous substances are contained in the article.

UBA has the following expectations:

• Manufacturers and importers must assume responsibility and ensure high quality of the information in their registration dossiers. They must carry out appropriate risk assessment; that is, according to state of the art and by taking into account the precautionary principle.
• Manufacturers, importers, and merchants must fulfil their duty to provide information on Substances of Very High Concern in articles – both along the supply chain and to users.
• All stakeholders in the value added chain ensure safety in the use of chemicals, mixtures and articles through implementation of recommended risk reduction measures.
• All Stakeholders in the value added chain aim for sustainability in chemicals use, e.g., by taking the initiative to either minimise or not use critical substances at all.