REACH

The REACH Regulation (EC) 1907/2006 is the European chemicals regulation for the registration, evaluation, authorisation and restriction of chemicals. The abbreviation "REACH" used for the regulation stands for Registration, Evaluation, Authorisationof Chemicals. It came into force in 2007 and plays an important role in the regulation and monitoring of chemical substances in the European Union. It is intended to ensure a high level of protection for human health and the environment. Essentially, REACH defines the obligations of companies that manufacture, import, use or sell chemicals. This includes registering chemicals, assessing their risks and passing on the information necessary for safe use along the supply chain.

The aim of the regulation is to collect information on chemical substances and take appropriate measures to protect people and the environment. The regulation is based on the precautionary principle, i.e. manufacturers, importers and downstream users take responsibility for their chemicals. Under the old chemicals legislation, the authorities were responsible for testing the safety of chemicals. Manufacturers only had to submit information if the official substance assessment revealed information gaps. This procedure proved to be slow and cumbersome. Under REACH, however, "no data - no market" applies: companies are not allowed to make their chemicals available to the EU market without prior registration.

The registration obligation under EU REACH applies to substances that are manufactured and/or imported (in total) in quantities of one tonne or more per year. Registration is carried out at the European Chemicals Agency (ECHA), which is responsible for the administration of EU REACH. The regulation considers the substance level, i.e. in the case of mixtures and articles, the registration obligation to be checked applies to the substances they contain.

Several companies wishing to register the same substance join together to form a joint registration, known as a joint submission. One company takes on the role oflead registrant (LR) and submits all physico-chemical, toxicological and ecotoxicological data on the substance for all co-/co-registrants. The information requirements depend on the tonnage band to be registered (see Annex VII - X of the REACH Regulation).

The co-registrants contribute to the costs of the lead registrant through the necessary acquisition of a Letter of Access (LoA) and may thus refer to the shared data. In the course of registration, the co-registrants must then submit their company-specific information.

After successful registration, the company receives a registration number and is therefore authorised to start manufacturing or importing the substance.

According to Article 22 of the REACH Regulation, companies are obliged to keep their dossiers up to date after successful registration. Various changes trigger the need to update the dossier, such as an increase in the tonnage band, new uses or a new classification and labelling. Since December 2020, there have been specific deadlines for the various update reasons listed in Article 22, which range from 3 to 12 months depending on the reason for the update.

In the case of a dossier update, the updated dossier is resubmitted to ECHA while retaining the registration number. As a rule, the update is not associated with any costs on the part of the authority, with the exception of an increase in the tonnage band.

In accordance with Article 41 of the REACH Regulation, ECHA has the option of checking registration dossiers for fulfilment of the legal data requirements. The dossiers are selected either randomly or on the basis of concerns. On the basis of this review, the authority can issue decisions with which missing or inadequate information is bindingly requested.

As part of communication in the supply chain, manufacturers and importers of substances and mixtures are obliged to provide their customers with the registration number, if available, as well as important information on the safe use of their chemicals. If the substances are classified as hazardous, persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) or if a substance is included in the candidate list of substances of very high concern (SVHC), information is passed on to downstream users via a safety data sheet (SDS).

If no safety data sheet is required, sufficient information must still be passed on along the supply chain to enable the safe use of the substances.

If a chemical safety assessment is required for a substance, manufacturers/importers must include this as exposure scenarios in the safety data sheet in the form of an annex (= "extended safety data sheet", eSDS). Downstream users must pass on new information on hazardous properties to the upstream actors. Uses not covered by the registration dossier must also be reported to the upstream actors in the supply chain. This gives the manufacturer/importer the opportunity to include this information in their registration dossier.

Adownstream user (DU) within the meaning of REACH is a company or an individual who uses a chemical substance as such or as a constituent of a mixture or article in the course of their industrial activity. Downstream users have certain obligations under the REACH Regulation. These include complying with the relevant regulations, using registered substances in accordance with the exposure scenarios provided and passing on relevant information along the supply chain. They must also ensure that the use of the substances is safe and does not cause unacceptable risks to human health or the environment.

Downstream users who manufacture formulations themselves (e.g. paints, varnishes) may be obliged to prepare and pass on a safety data sheet.

The REACH Regulation also provides for the authorization and restriction of substances. Substances subject to authorisation are generally prohibited and may only be used with official approval. Authorisation is based on a comprehensive assessment by the competent authority. Companies must provide detailed information on the properties and use of the substances and examine alternative, safer substances or technologies. Authorisation may be subject to certain conditions, such as the obligation to carry out monitoring measures or the search for less hazardous alternatives.

Restrictions, on the other hand, are introduced to limit or prohibit the manufacture, sale or use of certain hazardous substances. They can apply to individual substances or a group of substances and are based on scientific evidence of potential risks to humans and the environment. Restrictions can, for example, limit the use of substances in certain consumer products or limit the content of hazardous substances.

Non-EU manufacturers or formulators of substances and mixtures cannot register themselves, but they can appoint a company based in the EU as theirOnly Representative (OR). The Only Representative assumes the main obligations of an importer under REACH. He is responsible for registering the substances and providing the necessary information for the safety data sheets. In addition, the only representative is obliged to keep a list of EU customers and the quantities of substances imported each year. This must be made available to the enforcement authorities on request.

By appointing an only representative, the EU customers of the non-EU manufacturer or formulator become downstream users and are exempt from the obligation to register the substances covered by the only representative.

Substances that are eligible for an ECHA authorisation procedure are included in the so-called candidate list asSubstances of Very High Concern(SVHC) in a first step. These include, among others CMR substances (carcinogenic, mutagenic, toxic to reproduction), PBT substances (persistent, bioaccumulative, toxic) and vPvB substances (very persistent, very bioaccumulative).

Inclusion in the candidate list results in additional obligations for companies that handle these substances. These include the provision of a safety data sheet and information on safe use.

In addition, manufacturers, importers and distributors of articles containing substances of very high concern in a concentration of more than 0.1 per cent by weight have information obligations along the supply chain as well as the obligation to submit a SCIP notification.

As part of the CoRAP (Community Rolling Action Plan), the Member States assess substances to determine whether their use poses a risk to the environment or human health. For this purpose, further data is requested from the registrants in order to determine the potential hazards.

A further aim of the ECHA is to check the dossiers submitted for fulfilment of the registration requirements. The focus is currently on registrations over 100 tonnes/year that were submitted for the first time by 2018 and on registrations between 1 and 100 tonnes/year. If the authority identifies deficiencies in the dossiers, additional claims are made against the registrants.

PBT/vPvB refers to substances that are persistent (P), bioaccumulative (B) and toxic (T) or very persistent (vP, v for very) and very bioaccumulative (vB). This means that they

• can only be degraded poorly or very poorly in the environment (persistent),
• accumulate in organisms and are passed on via the food chain (bioaccumulative), and
• are also toxic to humans and/or organisms in the environment (toxic).

Determining the PBT properties of a substance is part of the assessment under REACH and registrants must generate information on degradability, bioaccumulation and acute or chronic (aquatic) toxicity and submit it to the European Chemical Agency (ECHA).

Substances that have been recognised as endocrine disruptors (EDs) have the potential to disrupt the natural hormone system of humans and animals, with negative consequences for health and, in particular, for their development. The mechanisms by which a substance has a negative effect on the hormone system can be diverse and are often difficult to prove. The data situation here is (still) comparatively poor, as the REACH Regulation does not yet specify any standard requirements in this regard. However, this is very likely to change with a revision of the regulation at the latest and the REACH regulation will be supplemented with specific (eco)toxicological tests and alternative methods for this endpoint. The greatest challenge here will be to prove the specific mechanism of the endocrine effect.