Does REACH need to register? REACH data sharing and disputes

REACH Registration - Phased Substances

There is a special substance that has been produced or sold on the market under certain conditions. This substance is called a phased substance. The company can benefit from the substances pre-registered by the transitional regime on December 1, 2008.

At least one substance in the following standards can be considered as a phased substance according to REACH (Article 3 (20)).

The listed substances are listed in the European Inventory of Existing Commercial Chemicals (EINECS)

Substances that have been produced in the EU (including countries, which joined on January 1, 2007) but have not been placed on the EU market after June 1, 1992

Identified as "substances without long chain polymer"

For these substances, the following deadline must be submitted at the time of registration:

November 30, 2010

The registration deadline for substances produced or imported from aquatic organisms or environmental hazardous substances of more than 1000 tons per year, carcinogenic, mutagenic or toxic reproductive substances of more than 1 ton per year, and more than 100 tons per year.

May 31, 2013

The registration deadline of substances produced or imported in 100-1000 tons per year.

May 31, 2018

The registration deadline of substances produced or imported annually between 1-100 tons.

All substances that do not conform to any standard phase are considered as non-staged substances. Generally, non-phased substances are not manufactured, marketed or used in the EU before June 1, 2008, according to Directive 67/548/EEC, unless they are notified.

Potential manufacturers and importers of non-phased substances must submit inquiries to ECHA and then register the substances according to REACH before they can produce or import the substances.

All substances notified according to Directive 67/548/EEC (also known as NONS) are considered to be all notifications of ECHA registered number according to REACH. The employer may request a registration number from ECHA.

REACH registration - do I need to register?

The following behaviors in the supply chain must comply with the registration process:

EU manufacturers and importers in their own substances or mixtures

Eligible articles from EU producers and importers explain the guidelines for substances in articles

The "sole representative" was established in the EU and appointed manufacturers, formula or article manufacturers outside the EU to fulfill the registration obligations of importers

REACH registration - data sharing

A basic aspect of REACH is the requirements of the EU for the production, import, marketing and use of substances for information sharing. In this way, registrants of the same substance can reduce costs and avoid unnecessary vertebrate tests. When information is available, studies involving vertebrate tests must be shared between registrants to prevent repeated tests. The new research involves vertebrates only as a last resort.

Data sharing is also jointly registered before a substance is produced or imported by more than one company.

There are two mechanisms for data sharing:

Substance Information Exchange Forum (SIEF Forum), used for pre-registration of phased substances

Query, used for non-phased substances and substances whose phases are not pre-registered

The registrant must make every effort to ensure the sharing of information. The cost of joint registration is determined in a fair, transparent and non-discriminatory manner. All parties must fulfill their data sharing obligations in a timely manner.

REACH registration - data sharing dispute

RECHA can help resolve disputes between existing and potential registrants in data sharing. A person who claims that he can only use it as a last resort to initiate all possible ways between the parties has explored.

Any data sharing disputes and ECHA decisions raised by potential registrants must always be submitted to ECHA before registration.

In case of disputes, ECHA's decision will reach an agreement based on the efforts of both parties. The cost of shared data will be assessed in a fair, transparent and non-discriminatory manner.

Starting the data sharing dispute procedure with ECHA must show the efforts made by all parties of a potential registrant to reach an agreement and provide corresponding written evidence.