Enquiry on REACH

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REACH applies only to legal entities established in the European Community. Therefore, companies established outside the Community that are exporting their products into the customs territory of the European Community are not bound by the obligations of REACH. The responsibility for fulfilling the requirements of REACH, such as pre-registration or registration lies with the importers established in the European Community, or with the only representative of a non-Community manufacturer established in the European Community.

Your company may nevertheless wish to support its partners established in the European Community in order to facilitate its business activities. It is therefore advisable to make yourself aware of the relevant information in the context of REACH. This includes in particular:

• The type of product imported into the EU, since the product type determines the requirements to meet.
• Information related to the substances contained in your products, which the importers or your only representative need for pre-registration and registration. This includes the identity of substance(s), the composition of each substance, its physico-chemical, toxicological properties or ecotoxicological properties.
• Deadlines that must be complied with.

1. What kind of products does your company produce for export to the EU?

Pre-registration and registration under REACH always refers 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 or additives. Manufacturing includes extraction of substances in its natural state, like for example hydrocarbon fractions from mineral oil.
The registration and notification obligations under REACH always refer to a substance as such, a substance in preparations or a substance in articles. There are however different registration obligations, depending on the point in time when a substance was manufactured, imported or placed on the EU market for the first time.

REACH distinguishes five types of products in which a substance may be contained. Depending on the type of product, the REACH obligation can vary. Thus it is essential to determine the type of product to be imported into the customs territory of the European Community.

A brief summary is given below:

• Substances as such, having phase-in-status under REACH
   
• Substances as such, having no phase-in-status under REACH
   
• Substances in a preparation
   
• Substance in an article, substance intended to be released
   
• Substance in an article, substance not intended to be released
   

The type of product determines the obligations of the EU based company importing the product (or the only representative). If you click on the type of product relevant for your business, a brief overview on obligations of the importer or the only representative, timelines and further information will be displayed.

Actions:

• Phase-in Substances
   
• Non phase in substance
   
• Preparations
   
• Articles, intended release of substances
   
• Articles, unintended release of substances
   

2. Are your products imported into the EU exempted from REACH registration requirements or regarded already registered?

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 obligations of the importer or the only representative, timelines and further information will be displayed (in printable form).

If your company’s products fall into one of the categories displayed below, the importers established in the European Community might have no registration or pre-registration obligation under REACH and thus the need for information may be more limited.

• Substances subject to customs supervisions in the European Community
   
• Substances used in medicinal products
   
• Substances used in food and feedingstuffs, including use as a food additive in foodstuffs
   
• Substances listed in Annex IV of the Regulation
   
• Substances which occur in nature
   
• Other substances listed in Annex V
   
• Substances re-imported into the EU
   
• Substances in plant protection and biocide products
   
• Waste
   

3. Why and how to appoint an only representative?

Each legal entity established in the European Community which imports your product into the EU will need to comply with the REACH obligations and in particular with the duties briefly outlined in section 1 above. These companies may approach you in order to seek assistance in compiling the relevant information needed for registration.
Your company may find it more convenient/efficient to get your substance(s) pre-registered and registered in the EU through an only representative (OR) according to Article 8 of the REACH Regulation. An only representative is a natural or legal person established in the EU appointed by your company via mutual agreement. This natural or legal person would fulfil, as your only representative (OR), the obligations on companies importing your substance as such, in preparations or in articles. REACH includes this option to support efficient procedures within your company and at the importers established in the European Community, as then a single EU based entity would deal with the pre(registration). You may also want to opt for this possibility if you believe that communication of information needed by the importers would require you to disclose any business secrets or may conflict with your existing Intellectual Property Rights.

• The only representative must be established in one of the EU Member States or in Iceland, Liechtenstein or Norway. That EU Member State will then enforce the requirements related to your product when imported into the EU.
• It will be the task of the OR to comply with all 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 OR to keep available and update the information 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 OR must therefore have a sufficient background in the practical handling of substances and the information related to them.
• The OR needs to be able to document for the enforcement authorities that he has been  appointed by your company and for which substance and volume the appointment applies. He may also indicate in the registration dossier by whom he was appointed.
• He needs to be able to document that your company has informed the importers who are covered and who may benefit from the OR having fulfilled the importers’ obligations.
• The OR can represent more than one non-Community manufacturer for a substance. However he has to submit separate individual registrations for each of these.
• The registration by the OR can cover volumes of the substance imported into the EU from any stage in the non-EU supply chains. Thus as long as your company can keep track and document via which channels the substance or preparation is imported into the EU, the volumes can be covered by the OR.
• The non-Community manufacturer can change his OR. If the former OR agrees, the new OR can submit an update of the registration, in which the new OR replaces the old one.
• Pre-registration and registration requires the (pre)registrant to sign-in via the REACH-IT system. Only legal entities established in the customs territory of the EU, Norway, Iceland or Liechtenstein can sign-up with ECHA.