Risk assessment of chemicals under REACH

The REACH Regulation applies to all substances (chemicals) manufactured or used in the EU, and to substances in mixtures or products (e.g. furniture or clothing). Exempted are radioactive substances, substances under customs supervision, the transport of substances, non-isolated intermediate products and polymers. Some exemptions apply to, for example, plant protection products, food additives or flavouring substances in food, or medicinal products. These substances are subject to different legal provisions.

Companies are obliged to examine the hazardous properties of the substances and to assess the risks they pose in order to ensure adequate protection of health and the environment. For this purpose, data on toxicity and use, including an assessment of the extent to which humans may be exposed to these substances, must be submitted to ECHAshort forEuropean Chemicals Agency. The testing requirements for the substances are based on the annual production volume (from 1, 10, 100 or 1000 tonnes per year and manufacturer) and building on each other.

The principle ‘No data, no market’ applies. A refinement of consumer protection is expected in particular through the implementation of substance-related restrictions (for example in toys) or the intake of substances in the authorisation procedure. Parts of the submitted data (e.g. on toxicity) are published on the ECHAshort forEuropean Chemicals Agency homepage.

The BfRshort forGerman Federal Institute for Risk Assessment is involved in enforcing the REACH Regulation as the ‘Assessment Body for Health and Consumer Protection’. In consultation with the ECHAshort forEuropean Chemicals Agency, the Federal Office for Chemicals and the other assessment bodies (Federal Environment Agency (UBAshort forGerman Environment Agency) and Federal Institute for Occupational Safety and Health (BAuA)), the BfRshort forGerman Federal Institute for Risk Assessment carries out health risk assessments of substances. This includes the assessment of the hazardous properties of substances and the estimation of the exposureClose dialogexposureExposureTo glossary of consumers to these substances. This data is used to carry out risk assessments of substances for which there is consumer exposure.

Every two years, the federal institutions responsible for REACH organise a REACH congress.

For substances of very high concern, the REACH Regulation provides for an authorisation procedure for their production or use. The aim of the procedure is to replace these substances with less hazardous ones and to authorise only those uses or manufacturing processes for these substances that pose no risk or for which there is no alternative. Substances that have been recognised as being of very high concern are considered candidates for authorisation. The next step in the process is to decide whether they require authorisation. Substances that require authorisation may no longer be produced or used after a specified expiry date. In order to continue producing them, manufacturers must apply for authorisation.

Recognised substances of very high concern are published on the so-called candidate list on the ECHAshort forEuropean Chemicals Agency website. Consumers have the option of asking the manufacturer, supplier or seller whether a product contains more than 0.1% of a substance from this candidate list.

If an unacceptable health risk arises from the production, import or use of substances, these can be subject to restrictions in the EU. For example, carcinogenic, mutagenic and reprotoxic substances in consumer products must not exceed certain concentrations. Restrictions can also be used to impose a complete ban on substances.

Substances with hazardous properties are classified in accordance with the Regulation on Classification, Labelling and Packaging of substances and mixtures (CLP Regulation). Manufacturers, importers and users of chemicals determine the classification of ‘their’ substances in accordance with the criteria in the CLP Regulation and report these classifications to the ECHAshort forEuropean Chemicals Agency (self-classification).

Certain hazardous properties of chemicals, however, are classified in a harmonised way, i.e. the classification is determined at EU level (legal classification). This applies in particular to carcinogenic, mutagenic and reprotoxic substances, as well as respiratory allergens. The harmonisation of classification is intended to ensure uniform protection throughout the EU against substances with these properties.

The REACH Regulation also applies to nanomaterials.

Under REACH, a substance evaluation can be carried out to investigate any suspicion of a harmful effect of a substance. If the available information on the substance is insufficient for the assessment, this may result in testing requirements for industry. As a result of the substance evaluation, a substance may also be subjected to one of the other procedures under REACH and thus regulated. The ECHAshort forEuropean Chemicals Agency publishes a list of all substances that are subject to the substance evaluation procedure on its website.