REACH, CLP and biocides for non-EU companies
REACH, CLP and biocides for non-EU companies
REACH and CLP only apply to legal entities established in the European Union and the other Member States of the European Economic Area, i.e. Norway, Iceland and Liechtenstein. Whenever this webpage refers to the EU, it should be read to cover these three countries too.
The responsibility for fulfilling the requirements of REACH and CLP, such as registration or labelling, lies with the importers established in the European Union, or for REACH obligations, with the only representative of a non-EU manufacturer established in the European Union.
Importers in the EU however need to turn to their non-EU suppliers and request information that they need to fulfil their regulatory obligations. As a non-EU manufacturer, you should support your customers further, i.e. importers established in the European Union, by appointing an only representative to fulfil the obligations of importers under the REACH Regulation.
As a first step, it is advisable to make yourself aware of the relevant REACH and CLP obligations. This includes in particular:
- What do you export to the EU? The answer to this question determines the requirements that need to be met.
- Do your exported products contain substances that require registration by the EU-importer?
- Are your exported products affected by regulatory requirements other than registration, such as notification or authorisation?
- What are the advantages and disadvantages of appointing an only representative to fulfil the obligations resting on importers?
- Do your exported products require classification, labelling and packaging in accordance with the CLP Regulation?
Pre-registration and registration obligations under REACH always refer to substances. A substance is defined as a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition (see Article 3(1) of REACH). A substance as obtained from a manufacturing process can consist of one or more constituents, impurities and/or additives. Manufacturing means the production or extraction of substances in their natural state.
The registration and notification obligations under REACH refer to a substance as such, a substance in a mixture or a substance in an article. There are different registration obligations depending on the point in time when the substance was manufactured, imported or placed on the EU market for the first time.
The following cases can be distinguished:
- the substance is listed in the European Inventory of Existing Commercial Chemical Substances (EINECS);
- the substance was manufactured in the EU at least once between 1992 and 1 June 2007 but not placed on the market by
- the manufacturer or importer; the substance was placed on the market before June 2007 and was considered as having been notified under the previous legislation (Directive 67/548/EEC), but does not meet the definition of a polymer as set out in the REACH Regulation ("no-longer-polymer").
If your product falls under one of the following categories you may wish to check in more depth whether it is exempted from all or certain REACH obligations. If you click one of the following categories, a brief overview on the exemption will be displayed (in printable form).
The enforcement of the provisions of the REACH Regulation and Regulation 2913/92 on the EU Customs Code is the task of the Member States of the European Union. It is therefore recommended to contact the national customs authorities for detailed information with respect to the enforcement practice in the respective Member State. National authorities are also best placed to answer questions related to the customs territory of the respective Member State. Please also consult section 188.8.131.52 of the Guidance on registration for further information.
Substances fulfilling the conditions of Article 2(5)(a) of the REACH Regulation are also exempt from the titles on downstream users, evaluation and authorisation (Titles V, VI and VII of the regulation).
Importantly, substances are exempted from these titles only to the extent that they are used in medicinal products. Quantities of the same substance used for a different purpose are not exempted.
The same exemption applies whether a substance is manufactured in the EU and used in the EU or exported to a third country. Imports of substances for that use from a third country are also covered by the same exemption and do not have to be registered under REACH.
Intermediates that are used for the production of medicines are not exempted from registration (in so far as they are not present in the medicinal product as defined in Regulation 726/2004, Directive 2001/82 and Directive 2001/83). You will find more information on this in the Guidance for intermediates.
Food or feedingstuff mixtures in the finished state, intended for the final user, are exempted from the provisions on information in the supply chain. (Article 2(6)(d) of the REACH Regulation).
The reason for these exemptions is that Regulation (EC) No 178/2002 on food safety already requires that food for humans and feed for animals cannot be placed on the market unless they are safe. REACH does not affect the application of the EU legislation on foodstuffs. More information is provided in section 184.108.40.206 of the Guidance on registration.
Please consult Annex V for detailed information on these substances. The terms "occurring in nature" and "chemically modified" are defined in Article 3(39) and (40) of the REACH Regulation.
The main purpose of this exemption is to avoid duplication of the registration of the same substance within the same supply chain. For more information please consult section 220.127.116.11 of the Guidance on registration.
Plant Protection Products
An active substance for use in plant protection products which fulfils the conditions specified in Article 15(1) of the REACH Regulation is regarded as registered for the purposes of REACH. In principle, this substance will undergo a thorough assessment based on information submitted under the legislation on plant protection products.
Co-formulants for plant protection products are mentioned in Article 15(1) of the REACH Regulation. Similarly to the provisions for active substances, co-formulants can be considered registered for the purposes of REACH. However, for this exemption to apply, co-formulants would need to appear either in Annex I of 91/414/EEC (Plant Protection Products Directive), or in one of the other specific pieces of legislation relating to plant protection products.
At this time, co-formulants are not listed in this legislation and are therefore treated as other substances for the purposes of REACH. Thus, a manufacturer or importer of these substances on their own, in mixtures, or in articles, in amounts of one tonne or more per year must register them.
An active substance that is manufactured or imported for use in biocidal products only and fulfils the conditions referred to in Article 15(2) of the REACH Regulation is regarded as registered for the purposes of REACH. In principle, these substances will undergo a thorough assessment based on information submitted under the legislation on biocidal products.
Co-formulants used in biocides are subject to the normal obligations under REACH, unless they are exempted on other grounds, such as Annex IV or V. A manufacturer or importer of these substances on their own, in mixtures or in articles in amounts of one tonne or more per year must therefore register these substances.
For both Biocidal and Plant Protection Products
When an active substance has a dual use in biocidal products/plant protection products and for other purposes, the quantity of the active substance used for purposes other than in a biocidal product or plant protection product is subject to the normal obligations under REACH. Thus, the manufacturer or importer of these substances on their own, in mixtures or in articles in amounts of one tonne or more per year must register them.
Further information on registration in relation to biocides and plant protection products can be found in section 2.2.4 of the Guidance on registration; guidance on calculating the relative tonnages can be found in section 2.2.6 of the Guidance on registration.
The definition of waste as contained in the Waste Framework Directive 2006/12/EC also applies under REACH. Waste is any substance or object that the holder discards, or intends or is required to discard. This may be waste from households (e.g. newspapers or clothes, food, cans or bottles) or from professionals or industry (e.g. filter dust, slag or spray-paint sludge). The REACH Regulation does not exempt waste from its provisions, but clarifies that waste is not a substance, a mixture or an article within the meaning of REACH. Thus, importing waste into the European Union or processing waste is an activity to which REACH does not apply.
It is however important to note that once waste is recovered, and in this recovery process a substance, mixture or article is produced, the REACH rules will in principle apply, as they would to any other substance, mixture or article manufactured, produced or imported in the EU. In specific cases, where a recovered substance is the same as a substance which has already been registered, an exemption from the registration obligation may apply.
The waste life stage of a substance and the related risk management measures are also to be addressed in the chemical safety assessment of the registrant, if such an assessment is required (see Article 14 of REACH).
Legal reference: Article 2(2) of the REACH Regulation
The obligations of the EU-based importer (or the only representative) depend on whether it imports a (phase-in or non-phase-in) substance on its own, in a mixture or in an article. If you click on the relevant link below, a brief overview on obligations of the importer or the only representative, timelines and further information will be displayed.
If importers have pre-registered the substance or if they can "late pre-register" they may benefit from the transitional regime. Depending on the volume they import, the registration was either due by 1 June 2013 (for substances imported into the EU at an annual volume of 100 tonnes or more per importer) or will be due by 1 June 2018 for substances imported into the EU at an annual volume of one tonne or more per importer.
Information on how your importers established in the European Union should register is available in the Guidance on registration.
To register a substance, they first have to submit an inquiry to ECHA and then prepare and submit a registration dossier. Guidance on how to inquire and to prepare a registration dossier is available in the Guidance on registration.
A substance contained in several mixtures (and possibly also imported on its own) is to be registered only once, but based on the total volume of the same substance imported by that registrant in mixtures or on its own.
- the total quantity of the substance in articles they import is over one tonne per year;
- the substance has not already been registered for that use.
The non-EU producer of articles may be contacted by the EU-importer for information on SVHCs in the imported articles. It is recommended that the non-EU companies take note of the Candidate List as well as the registry of intentions to include substances on the Candidate List.
If the substance is present in the article in a concentration above 0.1 % weight by weight (w/w), the importer of an article will need to inform its customers of the presence of any substances included in the Candidate List present in the article and provide information to ensure safe use of the article. There is no tonnage trigger for this obligation (i.e. it also applies below one tonne per year).
Unless the substance has already been registered for the particular use or the importer can exclude exposure to humans or the environment during normal or reasonably foreseeable conditions of use, the importer is also obliged to notify the presence of an SVHC in articles to the European Chemicals Agency if:
- the substance is present in those articles in quantities totalling over one tonne per producer or importer per year; and
- the substance is present in those articles above a concentration of 0.1 % weight by weight (w/w).
Information on how importers established in the European Union should identify the polymers and monomers; and their tasks and obligations is available in the Guidance for monomers and polymers.
Each legal entity established in the European Union that imports a substance on its own, in a mixture or in an article into the EU will need to comply with the REACH obligations and in particular with the duties briefly outlined above. These companies may approach you seeking assistance in compiling the relevant information needed for registration.
A non-EU manufacturer may find it more convenient/efficient to get its substances pre-registered and registered in the EU through an only representative, in accordance with Article 8 of the REACH Regulation. An only representative is a natural or legal person established in the EU, appointed by a non-EU manufacturer by mutual agreement. As an only representative, this natural or legal person would fulfil the obligations of companies importing a substance on its own, in mixtures or in articles. It thereby alleviates the regulatory obligations resting on importers. Non-EU manufacturers may also want to choose this possibility if they consider that communication of information needed by the importers would require the disclosure of confidential business information.
If you wish to make use of the only representative mechanism, please observe the rules outlined below. In addition, please consult the Guidance on registration to find a more in depth explanation on requirements related to only representatives.
The only representative must be established in one of the EU Member States or in Iceland, Liechtenstein or Norway. That Member State will then enforce the requirements related to your substance when imported into the EU.
It will be the task of the only representative to comply with all the obligations with which the importers of your products would have to comply. This includes submitting a pre-registration and a registration dossier for the substance imported into the EU to the European Chemicals Agency (ECHA) before the relevant deadlines expire. It will also be the task of the only representative to keep the information available and update on i) the quantities imported and ii) the importers covered by the appointment, as well as to iii) supply the latest update of the safety data sheet. The only representative must therefore have a sufficient background in the practical handling of substances and the information related to them.
Only representatives need to be able to document for the enforcement authorities that they have been appointed by your company and for which substance and volume the appointment applies. They may also indicate in the registration dossier by whom they were appointed. They need to be able to document that your company has informed the importers who are covered and who may benefit from the only representative having fulfilled the importers' obligations.
Only representatives can represent more than one non-EU manufacturer for one or more substances. However, they have to submit separate individual registrations for each substance and each non-EU manufacturer.
The registration by an only representative can cover volumes of a substance imported into the EU both directly from non-EU manufacturers and via non-EU distributors or formulators. Thus, as long as your company can keep track and document the channels through which the substance or mixture is imported into the EU, the volumes can be covered by the only representative. Non-EU manufacturers can change their only representative. Pre-registration and registration requires the (pre-)registrant to sign-up to the REACH-IT system. Only legal entities established in the customs territory of the EU, Norway, Iceland or Liechtenstein can sign-up to REACH-IT.
The obligation to ensure that a product is classified, labelled and packaged in accordance with the CLP Regulation lies with the EU-importer. However, the non-EU manufacturer of a substance or a mixture should cooperate with their importer to check the relevant requirements regarding the packaging and labelling of their product. They should also cooperate to ensure proper hazard classification of the product.