REACH certification

Meaning of REACH testing

REACH, short for Regulation concerning the Registration, Evaluation, Authorization and Restriction of Chemicals, is a chemical regulatory system established by the European Union and implemented on June 1, 2007.
This is a regulatory proposal involving the safety of chemical production, trade, and use. The regulation aims to protect human health and environmental safety, maintain and enhance the competitiveness of the EU chemical industry, develop innovative capabilities for non-toxic and harmless compounds, prevent market fragmentation, increase transparency in chemical use, promote non animal experimentation, and pursue sustainable social development. REACH establishes the concept that society should not introduce new materials, products, or technologies if their potential hazards are unknown.

 

Main content of REACH regulation
All chemical substances with an annual production or import volume exceeding 1 ton need to be registered, and chemical substances with an annual production or import volume of more than 10 tons should also submit a chemical safety report.
Evaluation includes both archival evaluation and material evaluation. Archive evaluation is to verify the completeness and consistency of the registration files submitted by enterprises. Material assessment is to confirm the risk of chemical substances to human health and the environment.
Authorisation authorizes the production and import of chemical substances with certain hazardous characteristics that are highly valued by people, including CMR, PBT, vPvB, etc.
Restriction: If it is believed that the manufacturing, placing on the market, or use of a substance, preparation, or item poses a risk to human health and the environment that cannot be fully controlled, its production or import within the European Union will be restricted.
Responsibilities and Obligations of Articles under REACH Regulation
If the product contains intentionally released substances and the annual export volume of the substance is greater than 1 ton, registration is required.
If the product does not contain intentionally released substances:
1) If the product contains substances of high concern (i.e. SVHC) and the content is less than 0.1%, there is no need to report or actively transmit information, but if the importer or consumer requests, there is an obligation to provide relevant information;
2) If the product contains SVHC and the content is greater than 0.1%, and the annual export volume is less than 1 ton, it must be notified and relevant information must be transmitted to downstream importers, and relevant certification documents must be issued to explain;
3) If the product contains SVHC and the content is greater than 0.1%, and the annual export volume is greater than 1 ton, it must be reported to ECHA;
4) At the request of consumers, all suppliers of goods should provide consumers with sufficient information within 45 days of receiving the request to ensure the safe use of the goods. This information should at least include the name of the substance.
Note: Currently, there are 155 substances on the SVHC list. You can click on the link to view http://echa.europa.eu/candidate-list-table
◆ Restricted substances
Annex 17 of the REACH regulation imposes restrictions on the manufacturing, placing on the market, and use of certain hazardous substances, preparations, and articles. It is an important task for articles other than SVHC. June 1st, 2009
The EU Directive 76/769/EEC on the restriction of substances has been abolished, and all relevant regulations have been included in REACH
Unified implementation of regulations. Any substance, whether it is itself or contained in formulations or articles, must be restricted within the European Union if its use poses unacceptable risks to human health and the environment. The restricted content is clearly defined in Annex 17.
What is SVHC
According to Article 57 of the REACH regulation, substances with one or more of the following hazardous characteristics that are of high concern:
(1) Class 1 and Class 2 substances that are carcinogenic, teratogenic, and have reproductive toxicity, namely CMR1/2 substances;
(2) Persistent, bioaccumulative, and toxic substances, namely PBT substances;
(3) Substances with high persistence and high bioaccumulation, namely vPvB substances;
(4) Substances with endocrine disrupting properties, persistence, bioaccumulation and toxicity, or high persistence, high bioaccumulation but not meeting the criteria of 2 or 3, and with scientific evidence proving serious impacts on humans or the environment.
When products contain SVHC, companies need to fulfill their responsibilities and obligations
When selling as a substance, it is necessary to provide SDS (Safety Data Sheet) to downstream users.
As a substance in a mixture (preparation), when the content of this substance is ≥ 0.1%, SDS needs to be provided to downstream users.
When the SVHC quality percentage in the item is greater than 0.1%, sufficient information, including the substance name and its content, must be provided free of charge to the recipient of the item or at the request of the consumer within 45 days.
SVHC listed before December 1, 2010, with a quality percentage concentration exceeding 0.1% and a total amount greater than 1 ton/year, must fulfill the obligation to notify ECHA by June 1, 2011. SVHCs listed after December 1, 2010, which meet the notification criteria, must complete the notification within 6 months after being listed.
SVHC Notification
On June 1, 2007, the EU REACH regulation - "Registration, Evaluation, Authorisation and Restriction of
The "Registration, Evaluation, Licensing, and Restriction of Chemicals" regulation has officially come into effect. The REACH regulation stipulates various responsibilities and obligations for chemicals and downstream items, and is a widely influential regulation to date.
The candidate list in Annex XIV of the REACH regulation is the SVHC list, which stipulates that manufacturers or importers of substances of high concern (SVHC) that meet the following two conditions should notify ECHA:
The total content of SVHC substances in the goods exceeds 1 t/y/manufacturer or importer;
The total content of SVHC substances in an article exceeds a concentration of 0.1% by mass fraction.
Who needs to make a notification
◆ EU manufacturers
◆ EU importers
◆ Non EU producers (must entrust a representative OR to carry out)
When to report
Substances listed on the SVHC list before December 1, 2010 must be reported within 6 months from June 1, 2011;
Substances listed on the SVHC list after December 1, 2010 must be reported within 6 months from the date of publication.

Why REACH needs to be notified
The EU implements REACH regulations for products circulating within its borders. Products within the European Union must comply with the obligations of the REACH regulation in order to be legally produced or imported. Strict regulatory and punitive measures have been passed by various countries in response to the REACH regulation legislation. EU customs can conduct REACH compliance reviews, and those who violate the REACH regulation may face product recalls, fines, or even imprisonment.
CPSIA testing, California 65 testing, REACH testing, ecological textile testing, textile and clothing testing, leather and footwear testing, electronic and electrical testing, jewelry testing, toy testing, sports equipment testing, furniture material testing, food contact material testing, packaging material testing, salt spray corrosion testing, metal composition analysis, formula composition analysis.

 

REACH testing mode

REACH testing is generally conducted using a mixed testing method, where all metal materials of the product are mixed into one material and non-metal materials are mixed into one material, and tested separately.

 

REACH registration regulations

REACH Registration - Phased Substances
There is a special substance that has been produced or sold on the market under certain conditions as a transitional regime before REACH came into effect. This substance is called a staged substance. The company can benefit from the pre registered substances of the transitional regime on December 1, 2008.
At least one substance that meets the following standards may be considered as a phased substance in accordance with REACH (Article 3 (20)).
The listed substances are listed in the European Inventory of Existing Commercial Chemicals (EINECS)
Substances produced in the European Union (including countries that joined on January 1, 2007) but not placed on the EU market after June 1, 1992
Recognized as a 'non long chain polymer' substance
For these substances, the following deadlines must be submitted during registration:
November 30, 2010
The registration deadline for substances produced or imported from aquatic organisms or the environment that are carcinogenic, mutagenic or toxic reproductive substances of 1000 tons or more per year, and hazardous substances of 100 tons or more per year.
May 31, 2013
The registration deadline for substances produced or imported annually in the range of 100-1000 tons.
May 31, 2018
The registration deadline for substances produced or imported between 1-100 tons per year.
All substances that do not meet any standard phase are considered non staged substances. Normally, non staged substances are not manufactured, sold or used on the market in accordance with Directive 67/548/EEC of the European Union before June 1, 2008, unless they are notified.
Potential manufacturers and importers of non phased substances must submit queries to ECHA and subsequently register the substance in accordance with REACH before they can produce or import the substance.
According to Directive 67/548/EEC (also known as NONS), all substances are considered to be registered under REACH, and ECHA has registered all notifications with registration numbers. Employers can request registration numbers from ECHA's notification.