REACH

Mapping of potentially harmful chemicals on target to meet 2027 goal

Mapping of potentially harmful chemicals on target to meet 2027 goal

The next step in mapping potentially harmful chemicals to evaluate all registered substances by 2027.

The main source of information on chemicals is substance registration dossier submitted under REACH registration. ECHA has created a mapping tool for all registered substances where each substance is assigned to the appropriate category pool. ECHA’s goal is to review by 2027 all registered chemicals above 1 tonne per year, assign them to the appropriate category pool and evaluate the further regulatory action of each substance (or group of substances).

In 2021, ECHA assessed 250 high-tonnage substances, which so far had not been assigned any pool, taking the next step towards achieving the set goal. For the group of substances registered in the range of 1-100 tonnes, only 1300 chemicals remained not assigned to any group.

In 2021 ECHA assessed in total 1900 chemicals and made a categorization based on further regulatory needs for each substance. The results were as follows:
  • 300 were classified for further risk management
  • 800 requires more registration data for risk assessment
  • 800 requires no further action

A new pool called “regulatory needs assessment” has also been introduced to show which substances are undergoing a group assessment.

In December 2021, ECHA published batch of the group assessments. This should bring entrepreneurs closer to ECHA’s activities and to enable anticipation of further steps that the committee plans to take in the future, as well as to develop a plan for replacing harmful substances with safer alternatives.

On the ECHA website you will find the full list of substances with the assigned category pool, or information on: whether the substance is subject to further regulatory needs, whether the evaluation has already been completed or is under development. For each substance, the table also shows the evaluating authority, the problem, status and suggested follow-up, and the date when the listing was last updated.

The results of the assessment are a key issue for entrepreneurs as they can affect:
  • inclusion of a substance in the authorization list
  • restrictions on the use of certain substances, including ED substances
  • the need to update REACH registration

The annual report of ECHA’s integrated regulatory strategy, to be published later this year, will include a thorough analysis of the mapping process and the suggested regulatory actions.

ECHA: Mapping of potentially harmful chemicals on target to meet 2027 goal

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Updated application for REACH authorisation formats

Updated application for REACH authorisation formats

ECHA has published an updated format for companies to use when applying for authorisation to use substances of very high concern (SVHCs).

The new format combines the analysis of alternatives, the socio-economic analysis and, when relevant, a substitution plan into a single document. 

The new format is easier for applicants to fill in. The possibility to submit separate documents has been removed making the application process more efficient and the documents more coherent. The instructions on confidentiality have also been updated.

At the same time, the opinion format for the Committees for Risk Assessment (RAC) and for Socio-Economic Analysis (SEAC) has been revised to take the General Court’s judgments in two authorisation cases into account.

The judgments concerned situations where suitable alternatives are available in general and the applicants would need to submit a substitution plan. As requested by the European Commission, the opinion format also includes “a conclusion on whether or not the applicant has shown that the benefits for society from using the substance outweigh the risk to human health or the environment”.

Applicants should start using these formats immediately.

However, applications may be submitted in the old format until the end of 2021 if applicants have already finalised or are close to finalising the content of their application.

ECHA link: https://echa.europa.eu/-/updated-application-for-authorisation-formats

Ekotox REACH authorisation link: https://ekotox.eu/reach-authorisation/

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