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Registration

No Data No Market

REACH requires the registration of substances manufactured in, or imported into, the EU in quantities at or above one tonne per year, unless an exemption applies. The substance can be on its own, in a mixture, or in an article with intended release. In general, a company must collect information on the properties and uses of the substance they manufacture or import and assess the hazards and potential risks posed. A standard set of data is required for each substance registered, depending on the total quantity of the substance placed on the market. The information is submitted to the European Chemicals Agency (ECHA) in a registration dossier via REACH-IT. A manufacturer or importer must complete their registration before a substance is placed on the market above one tonne in order to be compliant with the REACH registration obligations.

Exemptions from Registration

REACH provides exemptions for substances either from the regulation as a whole or from certain aspects of the regulation including registration. An exemption from registration applies to substances:

  • used in human or veterinary medicinal products;
  • used in food or feeding stuffs;
  • listed in in Annex IV of REACH;
  • covered by Annex V of REACH;
  • registered under REACH, exported from the EU and re-imported into the EU under specific conditions;
  • registered under REACH and which are recycled or recovered in the EU under specific conditions;
  • which are polymers; or
  • used in product and process orientated research and development (PPORD) (but requires submission of a notification to ECHA).

The Inquiry Process

An Inquiry dossier must be submitted to ECHA (via REACH IT) by a potential registrant before they begin the registration process, to determine if a registration is already in place for the substance they intend to register.  The inquiry dossier must contain sufficient data on the identity of the substance intended to be registered. Potential registrants must wait for the result of the Inquiry before submitting their registration or generating data, such as tests on vertebrate animals.

Following the submission of the Inquiry dossier, if a registration exists for the substance, ECHA directs the potential registrant to the relevant Co-Registrants page in REACH-IT, where they can find contact details for other registrants of the same substance. This will also alert the co-registrants of the intention of the potential registrant to register the substance. While ECHA directs potential registrants to relevant co-registrants, it is the responsibility of potential registrants and previous registrants to confirm substance sameness. The potential registrant discusses with the lead registrant as to how they can join the Joint Submission and obtain the necessary data to complete their own registration dossier for the substance.

A view of which substances are already registered can be obtained on the ECHA CHEM website.

Data Sharing

Data sharing is a core principle of REACH, with the aim of avoiding unnecessary animal testing and reducing registration costs. The ‘one substance, one registration’ principle requires registrants of the same substance to generate and share the data required for the registration dossiers. All registrants of the same substance come together to form a Joint Submission. A lead registrant is nominated, and they coordinate the collection and generation of necessary data and submit the joint registration dossier.

The Implementing Regulation (EU) 2016/9 on data sharing requires that costs relating to sharing and jointly submitting informationshould be determined and distributed between the co-registrants in a fair, transparent and non-discriminatory manner. In the case of a data sharing dispute which cannot be resolved amongst the co-registrants, ECHA can facilitate data access as a last resort. While registrants are required to share data, following the submission of the joint registration dossier, each member registrant must submit their own registration dossier individually i.e. one registration per legal entity, containing their company-specific information, including tonnage and uses and referring to the lead registrant’s dossier, where relevant.

The Registration Process

Dossier Preparation

The information required in a registration dossier will depend on which tonnage band the substance is registered in. Annex VII – Annex X of REACH list the specific endpoints, for the different tonnage bands, that must be covered in the registration dossier.

The registration dossier is comprised of two parts, a technical dossier and a chemical safety report (CSR). A CSR is only required for substances registered at greater than 10 tonnes per year. The following information should be included in the technical dossier:

  • The identity of the substance
  • Information on manufacture and use
  • Classification and labelling
  • Guidance on safe use
  • Robust study summaries of the information on the intrinsic properties
  • Proposals for further testing, if relevant
  • For substances registered in quantities between one and ten tonnes, the technical dossier also contains exposure related information for the substance (main use categories, type of uses, significant routes of exposure)

Chemical Safety Report (>10 tonne)

The chemical safety report (CSR) is the document resulting from the chemical safety assessment undertaken as part of the registration process and is the key source from which the registrant provides information to all users through exposure scenarios. The chemical safety assessment is carried out to demonstrate that the risks from exposure to a substance, during its manufacture and use, are controlled when specific operational conditions and risk management measures are applied. These conditions of use constitute the exposure scenario.  The 3 main steps in preparing the chemical safety assessment are hazard assessment, exposure assessment and risk characterisation.

An exposure scenario is a set of conditions that describe how a substance is manufactured or used, and the measures necessary to control exposure to humans and releases to the environment. For substances registered at and above ten tonnes per year, which meet the classification criteria, each identified use of the substance should have an exposure scenario, documenting all relevant routes of exposure and releases associated with that use. The exposure scenarios are communicated to downstream users via the extended safety data sheets. The CSR can be submitted separately by registrants or jointly covering all uses. Information on the manufacturing process and all identified uses in the EU is required to complete the CSR.

Guidance on the Chemical Safety Assessment:

Dossier Submission

Registration dossiers are prepared using IUCLID and submitted to ECHA via REACH-IT. Once the IUCLID file is prepared, the REACH-IT submission wizard guides the registrant step-by-step through the submission process. Prior to submission, the registrant should check that

  • the information in REACH-IT is up to date;
  • the company contact details are correct;
  • the correct company size is selected. This information will be used to determine the registration fee;
  • the dossier has been checked with the IUCLID Validation Assistant; and
  • the correct IUCLID file is saved on the registrant’s computer.

Post dossier submission 

Once ECHA receives a dossier, a submission number is assigned. This number is NOT a registration number – it is used as a reference in all correspondence relating to this registration until a registration number is assigned. All dossiers undergo ‘‘Business Rules'' checks to ensure that the dossiers fulfil the pre-requisites for ECHA to process them. Passing the business rules only confirms that the dossier is accepted for processing and does not mean that the registration is finalised. If there is a business rules failure, the registrant must correct the dossier and re-submit it.

After the dossier has been accepted for processing, a technical completeness check where the dossier is checked to certify that all the required information is included, is completed. If there is any information missing, the registrant will be given a deadline by ECHA to re-submit a complete dossier, with only one additional submission attempt allowed.

In parallel to the technical completeness check, the invoice is sent to the registrant via REACH-IT. Once the technical completeness check is successful and the invoice is paid, the dossier is considered complete and a registration number is assigned.

If there is a second completeness check failure or a failure in paying the relevant fee, the dossier is rejected.

Dossier maintenance

Once the registration is complete, the registrant has a responsibility to keep their dossier up to date. A dossier update is required in the event of a change of the substance composition, an increase of the tonnage band or the availability of additional information, for example, related to classification and labelling or following a substance evaluation by ECHA. For some types of updates, a fee is charged.

Publication of registration information and data confidentiality

ECHA publishes information from the registration dossiers on their public dissemination website (ECHA CHEM). The information published includes:

  • Identity of the substance
  • Results of studies on its intrinsic properties and hazard profiles
  • Levels where no adverse effects are expected for human health or the environment
  • Classification and labelling
  • Guidance on safe use

If not claimed confidential by the registrant, ECHA will also publish:

  • information on the degree of purity essential for classification and labelling,
  • total tonnage band,
  • (robust) study summaries,
  • information in the safety data sheet, and
  • trade name.

Under certain circumstances, the IUPAC name can be claimed confidential. In these cases, the registrant must provide a public name that ECHA can use for dissemination purposes.

Before submitting their dossier, registrants can request that certain data be kept confidential and to check what information will be publicly available. All confidentiality requests are assessed by ECHA and some incur a fee.

Supply chain communication

Registrants and downstream users of registered substances have a duty to communicate information though their supply chain. The registrant is responsible for including the registration number and exposure scenarios (if relevant) in the safety data sheets provided to customers. While downstream users should ensure that the available exposure scenarios cover their intended uses, if a particular use is not covered, they must cooperate with the registrant to ensure that their use is covered by the joint registration and appropriate exposure scenarios developed.

Further information

https://www.echa.europa.eu/web/guest/regulations/reach/registration