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EU REACH Registration, Evaluation, Authorization and Restriction of Chemicals

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Introduction to REACH:

The full name of REACH is "Registration, Evaluation, Authorization and Restriction of Chemicals", which is EU Regulation (EC) No 1907/2006, which is the EU regulation on the registration, evaluation, authorization and restriction of chemicals, which came into effect on June 1, 2007. . Its purpose is to ensure a high level of protection of human health and the environment, to promote the free movement of chemicals on the EU market, and to increase competitiveness and innovation.

 

SVHC List Latest News:

September 3, 2019: The European Chemicals Agency (ECHA) conducts a public consultation on 4 substances proposed for inclusion in the Substances of Very High Concern (SVHC) list with the following names:

• 2-benzyl-2-dimethylamino-1-(4-morpholinophenyl)butanone

• 2-Methyl-1-(4-methylthiophenyl)-2-morpholino-1-propanone

• Diisohexyl phthalate

• Perfluorobutanesulfonic acid (PFBS) and its salts

 

January 17, 2022: The European Chemicals Agency (ECHA) updated the SVHC list with the latest requirements of 223 items.

 

Applicable Product Range:

The scope of the REACH regulation is broad. It covers almost all non-food, feed and pharmaceutical commercial products, consumer products such as clothing and footwear, jewellery, electrical and electronic products, toys, furniture, and health and beauty products are within the scope of the REACH regulation.

 

Regulations:

Registration

Manufacturers and importers must apply for registration of any chemical that reaches the one tonne per year threshold, whether the chemical is present as a chemical itself, as part of a mixture, or as a substance or mixture released from an article. Since only EU-based individuals or EU-established companies can submit REACH registrations, non-EU companies wishing to register a chemical substance will need to appoint an Only Representative (OR) to do so on their behalf. The European Chemicals Agency (ECHA) is responsible for evaluating the information submitted for registration.

 

Restrition

Each restricted substance has a different range of conditions and restrictions. For example, a hazardous substance itself may be prohibited from being placed on the EU market, or products containing the substance in certain concentrations may be prohibited. Appendix XVII is a list of restricted substances, which will be updated regularly.

 

Authorisation

The purpose of authorization is to eliminate or effectively control the risks posed by chemicals, especially those harmful to human health or the environment. This process is divided into two main stages, each of which entails certain obligations on different stakeholders in the supply chain:

1. A substance has been identified as a Substance of Very High Concern (SVHC) and placed on the Candidate List. If the content of an SVHC exceeds 0.1% by weight, the information is immediately transmitted to the recipient of the item in the supply chain. Consumers can also request this information from retailers, which must be provided within 45 days. If the weight of SVHC in the article exceeds 0.1% and exceeds 1 ton per year, ECHA must be notified. The Candidate List is updated twice a year.

 

2. Substances on the Candidate List will be prioritized for inclusion in the Authorization List (Appendix XIV). SVHCs on the authorisation list cannot be used or imported into the EU after a specified date (known as the sunset date) unless they have already been authorised. The authorisation applies only to those chemicals that are used in the EU or imported into the EU, and items manufactured in the EU. However, it does not apply to items imported from the EU, and the authorisation list is updated approximately once a year.

 

3. All products manufactured in or imported into the EU must comply with all applicable REACH requirements. It is important to remember that compliance with one requirement does not imply exemption from the other requirements. For example, in addition to meeting the requirements related to the Candidate List, a product may also need to meet some restricted requirements.


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