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REACH Regulation in the European ***
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REACH Introduction

REACH, also known as Registration, Evaluation, Authorization and Restriction of Chemicals, or EU Regulation (EC) No 1907/2006, is an 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 for human health and the environment, promote the free flow of chemicals in the EU market, and enhance competitiveness and innovation capabilities.


Latest news on SVHC list

On September 3, 2019, the European Chemicals Agency (ECHA) conducted a public consultation on four substances proposed for inclusion in the list of Substances of Very High Concern (SVHC). The substance names are as follows:

·2-benzyl-2-dimethylamino-1- (4-methylphenyl) butanone

·2-methyl-1- (4-methylthiophenyl) -2-morpholino-1-propanone

·Diisohexyl phthalate ester

·Perfluorobutyl sulfonic acid (PFBS) and its salts

On July 16, 2019, the European Chemicals Agency (ECHA) updated the SVHC list with a new requirement of 201 items.


Applicable product scope

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


Regulatory content

register

Any chemical that reaches the threshold of one ton per year must be registered by manufacturers and importers, whether the chemical itself exists as a chemical substance, or as part of a mixture, or as a substance or mixture released from an article. Since only individuals or companies established in the European Union can submit REACH registration, non EU companies wishing to register a chemical substance need to appoint a sole representative (OR) to act on their behalf. The European Chemicals Agency (ECHA) is responsible for evaluating the information submitted for registration.

restriction

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

authorization

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 requiring different stakeholders in the supply chain to assume certain obligations:

A certain substance has been identified as a highly concerned substance (SVHC) and included in the candidate list. If the content of an SVHC exceeds 0.1% by weight, this information will be immediately transmitted to the recipient of the item in the supply chain. Consumers can also request this information from retailers, and this information must be provided within 45 days. If the weight of SVHC in an item exceeds 0.1% and exceeds 1 ton per year, ECHA must be notified. The candidate list is updated twice a year.

Substances listed on the candidate list will be prioritized for inclusion in the authorization list (Appendix XIV). Unless authorized, SVHC on the authorization list cannot be used or imported into the EU after a specified date (known as the sunset date). Authorization only applies to chemical substances used and/or imported into the EU, as well as items manufactured in the EU. However, it does not apply to goods imported into the European Union. This authorization list is updated approximately once a year.

All products produced or imported into the EU must comply with all applicable REACH requirements. It is important to remember that meeting one requirement does not mean exempting other requirements. For example, in addition to meeting the requirements related to the candidate list, a product may also need to meet some restrictive requirements.


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