What is REACH?
REACH (Registration, Evaluation and Authorisation of Chemicals) is the EU’s policy on chemicals. Depending on the use of the chemical substances the REACH legislation sets obligations, differing from the obligation to register chemicals to restrictions on the use of certain dangerous substances.
Although EU companies are technically responsible for meeting the obligations under REACH (Regulation (EC) 1907/2006), suppliers outside the EU will be required to provide information on the chemicals used in their products.
Answering the questions in this document can help you to determine if, and to what extent, REACH is relevant for you. Furthermore it refers to more detailed information on the possible obligations.
Are you exporting (mixtures of) substances to the EU?
Depending on the volume that your importer imports, the substance may be subject to registration. Again, this is the EU importer’s responsibility. Some substances, for example, food products and pharmaceuticals, are exempted from the obligation of registration. The possible obligations under REACH for some products may depend on the eventual use. For example, pigments that can be used in food and non-food products. They fall within the scope of REACH when used for non-food products, while they have to meet EU food legislation (and are exempted from obligations under REACH) when used in food. Read more information on registration in this document.
Are you exporting articles to the EU?
Producers of articles can be subject to obligations under REACH in several ways. Check the other questions, to see in what way it may affect you.
Does your product release substances intentionally? The intentionally released substance is seen as a substance as such, and therefore may be subject to registration.
Does your article contain ‘dangerous’ substances?
REACH restricts the use of certain substances for example substances with carcinogenic characteristics. On the one hand there are requirements for so called Substances of Very High Concern (SVHC).
If your product contains SVHC from the so called candidate list, your importer must provide information on safe use to the final users. If the substance is moved from the candidate list to Annex XIV of the REACH regulation your EU importer must ask the authorities for authorisation to place the product on the market en eventually replace it by safer substances. For you this means that you will have to provide information on the SVHC you use and probably look for substitutes for them.
Read more information on SVHC in this document
Furthermore REACH sets restrictions for specific substances and specific uses in Annex XVII of the Regulation. This Annex XVII is a direct transposition of the existing restrictions on the marketing and use of certain chemicals before REACH entered into force.
The restrictions concern specific substances and/or specific uses e.g. limitations on certain colorants in textiles or certain softeners in toys and childcare articles. Your product must comply with these requirements.
Read more information on restrictions in this document.
One very useful source of practical information can be your EU importer. He knows what his obligations are and what he expects from his suppliers to make it possible for him to meet these requirements. Also check if he provides tools that make it easier to show compliance, e.g. lists of chemicals that you should not use or software systems which you can use to make an inventory of used chemicals.
You are not the only company in your sector that may face difficulties in interpreting this relatively new and complex legislation. Several sector associations have studied the consequences of REACH for their products.
European Chemicals Agency (ECHA)
ECHA is the EU’s authority on REACH. Its website provides information on the Regulation, guidance on REACH provisions, IT tools for REACH uses and Frequently Asked Questions.
Member States’ competent authorities
Each EU Member State has appointed a national REACH helpdesk. All national helpdesks van be found here.
The EU Export Helpdesk
The EU Export Helpdesk provides information on legal requirements, tariffs, preferential arrangements, quotas and statistics. Under ‘my exports’ you can search for the requirements applicable to your products (all requirements, so not only regarding chemicals).
(Mixtures of) substances are subject to registration with ECHA, if they are exported to the EU. The actual requirements depend on the nature of the substance and if the volume is ≥ 1 ton per importer per year. Substances or mixtures in containers (e.g. printer cartridges) are considered ‘substances’ and are therefore subject to registration as well. Substances in articles which are intentionally released during their use (e.g. a fragrance in a scented eraser), also have to be registered. If substances fall under the obligation to register, but are not registered they may not be placed on the EU market.
How are you involved?
If you are exporting (mixtures of) substances (e.g. cosmetic ingredients) or articles that intentionally release substances which are not exempted from the obligation to register, it is most likely that your EU importers have already (pre-)registered the substance. However, they might need information from you on the substances you are using, to be able to meet their obligations. For the CBI target group, it is not expected that exporters will have to register substances themselves. However, to avoid the risk of discontinuation of your exports, communication with your importer in this matter is essential.
The obligation to register does not apply to substances used:
- in medicinal products for human or veterinary use;
- as a food additive in foodstuffs;
- as a food flavouring in foodstuffs;
- as an additive in feeding stuffs;
- in animal nutrition;
- substances included in Annex IV and Annex V of the Regulation.
- temporarily excluded: polymers, however monomers do need to be registered! (see guidance)
Pre-registration Until December 2008, chemical producers and importers in the EU had the opportunity to pre-register the chemicals used. Pre-registration provided registering companies with more time to obtain and compile the information necessary to complete the ‘normal’ registration. Substances that have not been pre-registered need to be registered as a new substance, which is a more complicated process. See the list of pre-registered substances.
Only representative If a substance is not registered by your EU importer, and you use substances subject to registration, you can appoint an ‘only representative’ to register the substance for you (you cannot register the substance yourself, since you are not an EU based company). An only representative can represent one or several non-EU companies. Read here the EU guidance on registration.
In order to import or use substances with properties that are deemed to be of very high concern (the so-called Substances of Very High Concern (SVHC)), for example because they are carcinogenic, persistent in the environment or bioaccumulative, EU companies must apply for an authorisation with ECHA before they may be used or placed on the market. The identification of a substance as Substance of Very High Concern and its inclusion in a Candidate List of SVHC is the first step of the authorisation procedure. Following the identification as SVHC, a substance may be included in the Authorisation list (Annex XIV of the REACH Regulation) and become subject to authorisation. If a SVHC is placed on the Authorisation list companies have to send an application to ECHA requesting the authorisation for specified uses of these substances.
Substances of very high concern include substances which are:
- Carcinogenic, Mutagenic or toxic to Reproduction (CMR) classified in category 1 or 2;
- Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB) according to the criteria in Annex XIII of the REACH Regulation; and/or
- Identified, on a case-by-case basis, from scientific evidence as causing probable serious effects to humans or the environment of an equivalent level of concern as those above (e.g. endocrine disrupters).
At the time of publication the Candidate List of SVHC contained 155 substances. Please note that substances are added to the Candidate List of SVHC frequently. To maintain up-to-date with the latest list, it is advised to check ECHA’s website on SVHC on a regular basis.
Companies may have immediate legal obligations following the inclusion of a substance on the Candidate List which are linked to the listed substance on its own, in preparations and articles:
- EU suppliers of articles which contain substances on the Candidate List in a concentration above 0.1% (w/w) have to provide sufficient information to their clients or upon request to a consumer within 45 days of the receipt of the request. This information must ensure safe use of the article and as minimum contain the name of the substance.
- And EU producers or importers of articles have to notify ECHA if their article contains a substance on the Candidate List. This obligation applies if the substance is present above 0.1% (w/w) and its quantities in the produced/imported articles are above 1 tonne in total per year per company.
To be able to meet these obligations, EU importers need to know if and which SVHC are present in the articles they buy.
Substitute It Now (SIN)
Inclusion of a substances in the Candidate List of SVHC is a clear sign that that particular substance should be considered unwanted and alternatives should be used where possible. To speed up the substitution of dangerous substances by safer alternatives, ChemSec (The International Chemical Secretariat) has developed its own list of substances which should be considered SVHCs based on the criteria established by the REACH Regulation (the SIN-list). The latest version of this list contains 626 substances. Although this list has no legal consequences, the industry may see it an advanced warning for restrictions to come and even some EU Member States’ governments advise to use this list when developing criteria for public procurement. Click here for ChemSec’s website on SIN.
SVHC will be gradually included in Annex XIV of the REACH Regulation. The aim of authorisation is to ensure that risks from SVHCs are properly controlled and that these substances are progressively replaced by suitable alternative substances or technologies, where these are economically and technically possible. There is no tonnage threshold for a substance to be subject to authorisation.
Once included in Annex XIV, the substances cannot be placed on the market or used after a to be set date (the so-called “sunset date”) unless authorisation is granted to the EU company using the substance, or placing it on the market.
At the time of publication, 22 substances subject to authorisation were included in Annex XIV to REACH. For the list, please download this study.
To get authorisation the EU company has to prove that the risks from the use of the substances are either adequately controlled or justified on socio-economic grounds. Furthermore it has to show that no alternatives are available. Authorisation will only be granted on a case-by-case basis for a limited period and will be reviewed after that period. Please note that there is no obligation for authorisation for SVHC in articles imported from outside the EU, although the obligation to notify the presence of these substances still applies. Read here the EU guidance on authorisation.
How are you involved?
It is your EU importer’s responsibility to apply for authorisation and, if necessary, provide notification of articles and their uses. Again he may need information from you on the substances used.
A possibly more important conclusion that could be drawn from the inclusion of a substance on the candidate list of SVHC is that it should be considered as a sign that these substances are ‘unwanted’ by the EU. The use of these substances may still be allowed (under conditions) for now, but it is highly probable that the use of these substances will be prohibited entirely in the future. It is therefore advised that you already start searching for alternatives, if you are currently using one of the substances on the candidate list of SVHC.
Restrictions may limit the manufacture, placing on the market or use of a substance within the EU territory. If restrictions apply to a substance, either on its own or in a mixture or article, any activity with this substance is only allowed if it is in compliance with the restrictions set by Annex XVII of the Regulation. This annex contains the list of all restricted substances, specifying which uses are restricted. The former restrictions set out in the repealed Marketing and Use Directive (76/769/EEC), e.g. the ban on asbestos and restrictions on the uses of certain azo-dyes, have been carried over to REACH.
How are you involved?
If you produce products containing one of the substances included in Annex XVII to the Regulation, you must meet the requirements. Otherwise your product will not be allowed on the EU market. Since most restrictions already existed before REACH, you may not notice any difference. Examples of restrictions include the use of phthalates in toys and childcare products or the ban on certain azo-dyes.
The CBI has identified the restrictions specifically relevant for your sector in their buyer requirements modules and for specific products in their product fact sheets. Go to CBIs Market Intelligence Platform and select your sector to see the Buyer Requirements Modules and the product fact sheets.
You can wait until your EU importer requests data on the chemicals that you use or are traceable in your product, but you can also anticipate the possible requests by EU importers with the following actions:
- Ask your buyer for their requirements regarding REACH.
- Create an inventory of all chemicals used, including raw materials and additional materials being used in your production processes and which can also be found in the final product (i.e. substances, substances in mixtures and/or substances that can be released by the final products). This inventory should include:
- Name of the substance;
- Characteristics of the substance (hazard data, safe use information, etc.);
- Quantity exported to the EU per year;
- Origin (where does it come from);
- Final destination (to whom sold). It might be necessary to gather information from your suppliers in order to complete your inventory.
- Check the website of the European Chemicals Agency to find out if the substances or uses in your inventory are exempted from the registration under REACH.
- Stay in close contact with your buyer.
For more information, please download the PDF version of this study.