Background of EU REACH

European Unions (EU) Registration, Evaluation, Authorization (Restriction) of Chemicals (REACH) Regulation

REACH is a regulation of the European Union, adopted to improve the protection of human health and environment from the risks that can be posed by chemicals, while enhancing the competitiveness of the EU chemicals industry. It also promotes alternative methods for the hazard assessment of substances in order to reduce the number of tests on animals.

In principle, REACH applies to all chemical substances; not only those used in industrial processes but also in our day-to-day lives, for example in cleaning products, paints as well as in articles such as clothes, furniture and electrical appliances. Therefore, the regulation has an impact on most companies across the EU.

REACH places the burden of proof on companies. To comply with the regulation, companies must identify and manage the risks linked to the substances they manufacture and market in the EU. They have to demonstrate to ECHA how the substance can be safely used, and they must communicate the risk management measures to the users.

If the risks cannot be managed, authorities can restrict the use of substances in different ways. In the long run, the most hazardous substances should be substituted with less dangerous ones.

REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals. It entered into force on 1 June 2007.

How does REACH work?

REACH establishes procedures for collecting and assessing information on the properties and hazards of substances. Companies need to register their substances and to do this they need to work together with other companies who are registering the same substance.

ECHA receives and evaluates each registrations for their compliance, and the EU Member States evaluate selected substances to clarify initial concerns for human health or for the environment. Authorities and ECHA's scientific committees assess whether the risks of substances can be managed.

Authorities can ban hazardous substances if their risks are unmanageable. They can also decide to restrict a use or make it subject to a prior authorisation.

REACH

Registration Process :

To minimize animal testing and data fee for each registrant, REACH encourages data sharing among all registrants by the joint submission of registration data to ECHA. The main principle of REACH is “one substance, one registration”.

During joint submission process, one of the member among the manufacture of same chemicals nominate himself as lead registrant and the lead registrant or REACH consortium will do most of the work such as data collection, development of technical dossier and Chemical Safety Report (CSR), and submission of joint registration dossier to ECHA. Other co- registrants only need to pay the lead registrant or consortium a fee to refer to the joint registration dossier and then prepare the individual part of the registration dossier in IUCLID6.

REACH TIMELINE :

Post 31st  May’2018, Deadline all chemicals are treated equally and chemicals which were not registered within REACH with European Chemical Agency will not be allowed to be marketed or manufactured within EU.

Registration Dossier:

A registration dossier consists of two parts: Technical Dossier and Chemical Safety Report.

1. Technical Dossier

• Identity of manufacturer/importer;
• Identity, volume and identified uses of substance;
• Classification and labelling;
• Study report and robust study summaries according to Annex VII to X (physiochemical, toxicological, eco-toxicological properties, );
• Testing proposal;
• Statement whether tests have been carried out on vertebrate animals;

2. Chemical Safety Report (> 10 ton per year)

• Human hazard assessment, physicochemical properties assessment, environmental hazard assessment and PBT/vPvB assessment;
• Exposure Scenario is required if classified as dangerous or PBT/vPvB; Ÿ operational conditions and risk management measures for each use; exposure estimation

REACH Registration Cost Estimation

The total registration costs mainly consist of three parts:

Data fees paid to lead registrant or Consortium to purchase letter of access to refer to the common parts of registration dossier. The fee is tonnage dependent. Data fee varies from substance to substance. It is fixed by consortium or lead registrant. It is also tonnage based.

OR consultancy fees paid to OR to advise the whole registration process and prepare the individual part of registration dossier in IUCLID 6. The service fee covers SIEF/consortium communications, data gathering, IUCLID 6 dossier preparation and submission.

ECHA fees paid to European Chemical Agency. The fee is dependent on the annual tonnage of the substance and company size. Small and medium-sized enterprises (SME) enjoy discounts on ECHA fees (Euros).

Roles and responsibilities of REACH Only Representative :

In accordance with the Article 8 of REACH, the OR takes on the obligations of importers under REACH, in which case importers will be regarded as downstream users (thus do not need to register). Those obligations include:

• Maintain pre-registration /registration data (company identity, annual tonnage, etc.) submitted to ECHA through REACH-IT.
• Communicate with the downstream users (EU buyers).
• Represent Non-EU company in SIEF/Consortium after pre-registration and keep them informed of the latest progress of SIEF/Consortium.
• Supply Safety Data Sheets or transmit SDS along the supply chain and keep information on the supply of the latest update of the SDS.
• Communicate with EU importers and regulatory authorities and issue necessary documents to ensure REACH compliance.
• Keep an up-to-date list on the inventory of importers and the tonnage covered for each of these importers and keep the above information for at least 10 years and provide it to enforcement authorities upon request.
• Registration, notification and authorization of substances (additional contract needed).

Exempted Substances 

Substances exempted from the REACH Regulation

• Radioactive substances
• Substances under customs supervision
• Substances used in the interest of defence and covered by national exemptions
• Waste
• Non-isolated intermediates
• Transported Substances

Substances exempted from registration

• Substances included in Annex IV of the REACH Regulation
  • Annex IV lists a number of substances for which it is understood that sufficient information is available to consider them as causing minimum risk to human health and the environment. These substances are typically of natural origin and the list of exempted substances includes, for example, water and nitrogen.
  • The list is largely based on the exemptions from Regulation (EEC) No 793/93 on risk evaluation of existing substances, although more substances were added. The registration exemption applies to the substance as such, not to a particular use.
• Substances covered by Annex V of the REACH Regulation
  • Annex V lists thirteen broad categories of substances for which registration is deemed inappropriate or unnecessary. The registration exemption applies to the substances as such, if they meet the conditions for the exemption which are given in the particular category of Annex V.
  • Certain substances that are adequately regulated under other legislations, like substances used in food, animal feed, or in medicinal products, where the relevant criteria are met. Quantities of the same substance used for other uses than food, animal feed, and medicinal products are not exempted from registration.
• Polymers are exempted while the monomer substances or any other substances they consist of must be registered provided certain conditions are fulfilled.
• Recovered substances that are already registered
• Re-imported substances
• Substances used in product and process orientated research and development (PPORD)

For each category mentioned above, there are specific conditions under which the exemptions from registration under REACH apply, which need to be fulfilled to benefit from the exemption.

Authority

The European Chemicals Agency (ECHA) is an agency of the European Union which manages the technical and administrative aspects of the implementation of the European Union regulation, REACH. The Agency contributes to a well-functioning internal market and the innovation and competitiveness of the European chemicals industry.

ECHA develops independent scientific and technical opinions and takes binding decisions to ensure that chemical companies comply with European law. The Agency plays an important role in reducing chemical pollution in the EU. Together with the EU Member States and the European Commission, ECHA ensures safer chemicals use in Europe by improving the available data, disseminating and checking it, as well as proposing risk management measures when needed. The Agency also contributes to sustainability and circular economy.

An independent Management Board governs the Agency. It is composed of representatives from EU Member States, the European Commission, the European Parliament, and stakeholder organisations.

Concerned Bodies

The registration obligations under EU-REACH apply to EU manufacturers and importers of substances on their own or in mixtures in quantities of 1 TPA or more. Furthermore, they apply to EU producers and importers of articles in case that the article contains a substance in quantities over 1 TPA and the substance is intended to be released under normal or reasonably foreseeable conditions of use of the article. The registration obligation does not apply to downstream users or distributors.

The registration obligations of importers can be taken over by an Only Representative (OR) established in the EU and appointed by a manufacturer, formulator or article producer established outside the EU.

Any manufacturer, importer, or where relevant downstream user, may, whilst retaining full responsibility for complying with his obligations under this Regulation, appoint a third-party representative for all proceedings involving discussions with other manufacturers, importers, or where relevant downstream users. In these cases, the identity of the manufacturer, importer, or downstream user who has appointed the representative shall not normally be disclosed by the Agency to other manufacturers, importers, or, where relevant, downstream users.

Authority Fee

The size of the authority fee depends on the type of submission. The fee for registration can be found in Table 11. Fee reductions further apply to MSMEs (micro, small, and medium enterprises). The criteria for MSMEs is given in Table below.

Registration Authority Fee under EU-REACH

Criteria for MSME under EU-REACH

When declaring SME (micro, small and medium enterprise) size and claiming the SME fee reductions, a registrant must upload a complete set of supporting documentary evidence to ECHA.