Reach introduction

The full name of reach is "registration, evaluation, authorization and restriction of chemicals", i.e. EU regulation (EC) no 1907 / 2006. It is an EU regulation on the registration, evaluation, authorization and restriction of chemicals, which officially entered into force on June 1, 2007. Its purpose is to ensure a high level of protection for human health and the environment, promote the free circulation of chemicals in the EU market, and improve competitiveness and innovation capacity.

Reach regulation (EC) no 1907/2006 is the abbreviation of "registration, evaluation, authorization and restriction of chemicals" and the full name of "chemical registration, evaluation, authorization and restriction". It is a regulation of the European Union on the preventive management of all chemicals entering its market.

The reach regulation was passed in December2006, took effect on June 1st, 2007 and came into force on June 1st, 2008.

Main contents of reach

Registration all chemical substances with an annual output or import of more than 1 ton need to be registered, and chemical safety report (CSR) shall also be submitted for chemical substances with an annual output or import of more than 10 tons. Non EU enterprises must rely on or based on the sole representative of the EU to submit registration on their behalf. Reminder: enterprises can obtain the registration buffer period through pre registration or post pre registration. During the buffer period, enterprises can use the pre registration number to conduct normal production and trade in the EU.

Evaluation includes archive evaluation and material evaluation. File evaluation is to check the integrity and consistency of the registration files submitted by enterprises. Substance assessment refers to confirming the risk of chemical substances endangering human health and the environment.

Authorization authorizes the production and import of chemical substances with certain hazardous characteristics and which have attracted great attention. Enterprises need to authorize the substances listed in Annex XIV of reach regulation. At present, annex XIV contains 31 substances (list of authorized substances). Authorized substances are evaluated and screened from the list of authorized candidate substances (SVHC). At present, there are 168 substances in the SVHC list.

Restriction: if it is considered that the manufacturing, placing on the market or use of a substance or its configuration and products can not fully control the risks to human health and the environment, its production or import within the EU will be restricted. Restricted substances and conditions refer to the corresponding provisions of annex XVII of reach regulation.

Supply chain information transmission chemical safety use information (risk management measures) needs to be transmitted on the supply chain in the form of safety data sheet (SDS) or chemical safety report.

Impact of reach

REACH regulations not only have a great impact on the chemical industry, but also other industries such as electronics, toys, textiles and tires. Under the REACH regulations, chemical enterprises need to do reach registration and prepare SDS; Article manufacturers and importers shall report when the SVHC in the product exceeds the limit and transfer the supply chain information, and ensure that the hazardous substances in the product do not exceed the regulatory limit.

Some substances are completely exempted from reach regulations, such as radioactive substances; Some substances are exempt from some provisions of REACH regulations, for example, polymers are exempt from reach registration, but still have to fulfill other obligations under REACH regulations.

Reach completely exempted substances

● radioactive substances;

● substances under customs supervision;

● national defense requires substances exempted by the state;

● waste;

● non segregated intermediates and transported substances.

Substances exempted from reach registration

● substances used in food;

● pharmaceutical products;

● substances listed in Annex IV of REACH Regulation (68 known substances, such as nitrogen and corn oil, are safe);

● substances contained in Annex V of reach regulation;

● substances not chemically modified in nature. Minerals, ores, concentrates, cement clinker, natural gas, liquefied petroleum gas, natural gas condensate;

● substances other than those listed in paragraph 7 of the regulation that are not chemically modified in nature, unless they meet the 67/548/eec classification criteria, such as beeswax and some fibers;

● polymer (monomer must be registered);

● the recycled substances have been registered;

● re imported substances;

● substances used in developing products and improving production process (PPORD); PPORD should be submitted.

Deemed registered substance

● active substances in biocides;

● use of active substances in plant protection products;

● substances notified under Directive 67/548/eec.

What is SVHC

According to Article 57 of reach regulation, substances meeting one or more of the following hazardous characteristics can be identified as SVHC "substance of very high concern".

1. class 1, class 2 carcinogenic, teratogenic and reproductive toxic substances, i.e. cmr1/2 substances;

2. persistent, bioaccumulative and toxic substances, namely PBT substances;

3. Substances with high persistence and bioaccumulation, namely vpvb substances;

4. substances that have endocrine disrupting properties, or have persistence, bioaccumulation and toxicity, or have high persistence and bioaccumulation but do not meet the standards of item 2 and 3, and have scientific evidence to prove that they have a serious impact on human beings or the environment.

SVHC authorization candidate list

The competent authorities or agencies of Member States may propose to include substances in the SVHC candidate list by submitting the dossier of substances that meet the above characteristics. Stakeholders will be invited to comment on the substance in the dossier. After the discussion, the substance will be identified as SVHC substance, i.e. authorized candidate substance.

Authorized substances are some substances preferentially selected from authorized candidate substances, namely SVHC substances, and are listed in Annex XIV (authorization list). Manufacturers, importers or downstream users in the supply chain need to submit an authorization application 18 months before the sunset date. Only after obtaining the authorization can they obtain the right to use or put on the EU market. The current authorization list contains 31 substances.

So far, there are 168 substances in the SVHC list, and the release process of the list is as follows:

● on october28,2008, the European Chemicals Management Agency (ECHA) confirmed that 15 substances were included in the candidate list for authorization of REACH Regulation (the first batch of SVHC list).

● on january13,2010, the European Chemicals Management Agency (ECHA) confirmed that 14 substances were included in the candidate list for authorization of REACH Regulation (the second batch list of SVHC).

● on march30,2010, the European Union Chemicals Management Agency (ECHA), the competent authority of reach regulation, officially listed acrylamide as a substance of high concern.

● on June 18, 2010, the European Chemicals Management Agency (ECHA) decided to include eight substances in the candidate list for authorization of REACH Regulation (the third batch of SVHC list).

● on December 15, 2010, the European Chemicals Management Agency (ECHA) officially released the SVHC fourth batch list of 8 substances (SVHC fourth batch list).

● on June 20, 2011, the European Chemicals Management Agency (ECHA) officially released the SVHC fifth batch list of 7 substances (SVHC fifth batch list).

● on december19,2011, the European Chemicals Management Agency (ECHA) officially released the SVHC Sixth Batch List of 20 substances (SVHC Sixth Batch List).

● on june18,2012, the European Chemicals Management Agency (ECHA) officially released 13 substances in the SVHC Seventh Batch List (SVHC Seventh Batch List).

● on december19,2012, the European Chemicals Management Agency (ECHA) officially released 54 substances in the SVHC eighth batch list (SVHC eighth batch list).

● on June 20, 2013, the European Chemicals Management Agency (ECHA) officially released the six substances in the SVHC ninth batch list (SVHC ninth batch list).

● on December 16, 2013, the European Chemicals Management Agency (ECHA) officially released the SVHC 10th batch list of 7 substances (SVHC 10th batch list).

● on June 16, 2014, the European Chemicals Management Agency (ECHA) officially released four substances in the 11th batch of SVHC list (the 11th batch of SVHC list).

● on december17,2014, the European Chemicals Management Agency (ECHA) officially released six substances in the SVHC 12th batch list (SVHC 12th batch list).

● on june15,2015, the European Chemicals Management Agency (ECHA) officially released two substances in the 13th batch list of SVHC (the 13th batch list of SVHC).

● on December 17, 2015, the European Chemicals Management Agency (ECHA) officially released five substances in the fourteenth batch list of SVHC (the fourteenth batch list of SVHC).

When the product contains SVHC, the enterprise needs to fulfill its responsibilities and obligations

When sold as a substance

● the enterprise needs to provide SDS (safety data sheet) to downstream users;

● if the substance is listed as an authorized substance, it is required to submit an authorization application 18 months before the sunset. After obtaining the authorization, it can continue to trade and use in the EU;

● if the substance is listed in the restricted clauses of annex XVII of reach regulation, relevant requirements of restriction shall be met.

As a substance in a mixture (preparation)

● when the content of this substance is ≥ 0.1%, the enterprise needs to provide SDS (safety data sheet) to downstream users;

● if the substance is listed as an authorized substance, it is required to submit an authorization application 18 months before the sunset. After obtaining the authorization, it can continue to trade and use in the EU;

● if the substance is listed in the restricted clauses of annex XVII of reach regulation, relevant requirements of restriction shall be met.

When the article contains SVHC

● when the mass percentage of SVHC in the article is more than 0.1%, the recipient of the article or the consumer must be provided with sufficient information available free of charge within 45 days, including the name and content of the substance.

● for SVHC listed before december1,2010, if the mass percentage concentration in the articles exceeds 0.1% and the total amount is greater than 1 ton / year, the obligation to notify ECHA must be completed on june1,2011. SVHC listed after December 1, 2010 must complete the notification within 6 months after listing if it meets the notification conditions; SVHC notification

● if the substance is listed as an authorized substance, it is required to submit an authorization application 18 months before the sunset. After obtaining the authorization, it can continue to trade and use in the EU;

● if the substance is listed in the restricted clauses of annex XVII of reach regulation, relevant requirements of restriction shall be met.

SVHC compliance services

● SVHC detection / compliance assessment: it can provide reliable SVHC detection services and limit troubleshooting detection services to help you determine the concentration and limit of SVHC in the product, and customize the SVHC compliance assessment report (English template) for you to prove that your product complies with REACH regulations.

● SVHC notification: by detecting the SVHC concentration in the product and calculating the total export volume, the enterprise can help judge whether the notification conditions are met. For those meeting the notification conditions, SVHC notification service can be provided for you.

● drafting safe use instructions or SDS: if the SVHC content in your product is >0.1%, we will help you draft safe use instructions or SDS.

● authorization: if the substance in the product is an authorized substance, we will help you apply for authorization from ECHA.