REACH requires the registration of chemical substances manufactured or imported into the EU in quantities exceeding 1 metric ton per year. This requirement applies per substance and per manufacturer or importer (as appropriate). Registration applies to chemical substances as such, in preparations (also called “mixtures”) and, under certain conditions, to articles (finished products) incorporating those substances.
In principle, REACH applies to all chemical substances; not only those used in industrial processes but also in our day-to-day lives, for example in cleaning products, paints as well as in articles such as clothes, furniture and electrical appliances. Therefore, the regulation has an impact on most companies across the EU.
REACH places the burden of proof on companies.
REACH assigns the obligation to register on the EU based manufacturer or EU based importer. Many U.S.-based companies prefer to appoint an “only representative” to register their product(s) rather than rely on their EU-based customers to do so.
Bearing in mind that the cost and burden of registering can be daunting, the EU exempted a limited number of substances from the registration requirement. These exemptions apply to:
- Chemical substances imported into the EU or manufactured in quantities below 1 metric ton;
- Chemical substances used for research and development;
- Waste;
- Chemical substances whose uses are covered by other EU legislation such as medicine and food products;
- Pesticides and biocides;
- Polymers; and,
- Companies that had notified chemical substances under previous EU legislation (Directive 67/548/EEC).
Annex IV and V of the REACH regulation lists a number of other chemical substances exempted from REACH. Dossier list includes minerals, ores, cement clinkers, crude oil, coal, and coke; on the condition that they are not chemically modified.
- Evaluation
There are two aspects to the REACH evaluation process: dossier evaluation and substance evaluation. For dossier evaluation, ECHA (European Chemicals Agency) is statutorily required to perform a compliance check on at least 5% of the dossiers submitted for registration. Dossier evaluation focuses on completeness and quality of information. ECHA will notify the registrant of any deficiencies.
For substance evaluation, each year ECHA and the EU Member States select 30 chemical substances for placement on the “Community Rolling Action Plan”, commonly referred to as “CoRAP”, for further evaluation. The Members States focus on those chemical substances that are manufactured/imported in large quantities and which are persistent and prone to bioaccumulation.
- Authorization
U.S. companies that wish to export or use within the EU chemical substances identified as a “substance of very high concern” (SVHC) must ensure that a use-authorization has been obtained. The policy objective of this requirement is to ensure adequate control and progressive replacement of these substances.
- Restriction
The restriction is another means under REACH that allows the European Commission to control the use of dangerous chemical substances circulated within the common market. Any chemical substance on its own, in a preparation or in an article may be subject to EU-wide use restrictions that limit or prohibit its production or use.
Chemical substances subject to restrictions can be found in REACH Annex XVII. The following link will direct you to the ECHA webpage with the most up-to-date information on chemical substances subject to restriction:
https://echa.europa.eu/substances-restricted-under-reach
REACH’s effect on companies
REACH impacts on a wide range of companies across many sectors, even those who may not think of themselves as being involved with chemicals. In general, under REACH you may have one of these roles:
Manufacturer: If you make chemicals, either to use yourself or to supply to other people (even if it is for export), then you will probably have some important responsibilities under REACH.
Importer: If you buy anything from outside the EU/EEA, you are likely to have some responsibilities under REACH. It may be individual chemicals, mixtures for onwards sale or finished products, like clothes, furniture or plastic goods.
Downstream users: Most companies use chemicals, sometimes even without realizing it, therefore you need to check your obligations if you handle any chemicals in your industrial or professional activity. You might have some responsibilities under REACH.
Companies established outside the EU: If you are a company established outside the EU, you are not bound by the obligations of REACH, even if you export their products into the customs territory of the European Union. The responsibility for fulfilling the requirements of REACH, such as registration lies with the importers established in the European Union, or with the only representative of a non-EU manufacturer established in the European Union.
Extended safety data sheets
Safety data sheets include information about the properties of the substance or mixture, its hazards and instructions for handling, disposal and transport and first-aid, firefighting and exposure control measures. The format and content of the safety data sheets are specified in REACH. A safety data sheet should be provided to downstream users for:
- A substance or mixture that is classified as hazardous according to CLP (Classification, Labelling and Packaging regulation (EC) No 1272/2008).
- A substance that is persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB), or
- A substance that is included in the Candidate List of substances of very high concern (SVHCs).
However, if the substance or mixture is also sold to the general public, an SDS does not need to be provided unless requested by a downstream user or distributor.
For mixtures which are not classified as hazardous, but which contain certain hazardous substances, an SDS should be provided if requested by downstream users or distributors.
The safety data sheet should be updated without delay if new information becomes available on the hazards or the need for more stringent risk management measures.
When downstream users receive a safety data sheet, they need to identify and apply appropriate measures to adequately control the risks. Suppliers and recipients of SDSs are encouraged to check that the required information is provided. A checklist was developed by ECHA and enforcement authorities and is available for this purpose. Downstream users are encouraged to inform their suppliers about inaccuracies or inconsistencies in the SDS received.
Spencer-SHE has been providing Safety, Health, and Environmental Compliance Guidance since 1980. Our team can assist in the identification and evaluation of chemical substances as well as the completion of safety data sheet(s). We can maintain documentation and update as needed.
Contact us here to help you to develop and maintain a safe and healthy workforce.
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https://echa.europa.eu/regulations/reach/understanding-reach