Essential Use Concept according to European Commission

wfbadmin — Fri, 23 Aug 2024 15:53:37 +0000

As part of the Chemicals Strategy for Sustainability, on April 22, 2024 the European Commission adopted “Guiding criteria and principles for the essential use concept in EU legislation dealing with chemicals”. The Communication stresses the importance of phasing out these substances and states that no use can be considered essential if alternatives exist.

Harmful Substances

The Communication provides a broad definition of substances with hazardous properties, including not only carcinogenic, mutagenic and toxic for reproduction (CMR) substances, but also persistent, bioaccumulative and toxic/very persistent and very bioaccumulative (PBT/vPvB) substances, endocrine disruptors, respiratory sensitizers and toxic to target organs (STOT-RE).

Concept of ‘Essential Uses’

The Commission defines the concept of “essential use” to ensure that the most harmful chemicals are authorised only for specific purposes and for a limited period, provided that:

the use is necessary for health or safety or serve an essential function to society; and
there are no acceptable alternatives.

These criteria serve as guiding principles, to adapt with some flexibility to the specificities and objectives of each legislation in which the concept will be applied. The Commission clarifies that, although technical and economic feasibility will be considered in the analysis of alternatives, existing references in legislation such as REACH will not be changed.

Aim of the Communication

The main aim is to improve the protection of health and the environment by accelerating the decision-making process to phase out non-essential uses of hazardous substances and, where necessary, allowing a transition period for their substitution.

Application of Concept of “Essential Use”

The use of a substance may be essential in one product or context. The Commission specifies that an entire sector, such as healthcare or food packaging, will not be exempted from the essential use concept. Instead, specific individual uses within these sectors will be assessed. The assessment will be “per use” and not “per user”.

Evaluation of alternatives

According to the Commission’s Communication, the assessment of the acceptability of alternatives should consist of:

identifying possible alternatives that can provide the technical function needed for the final product to deliver the intended service and
assessing their acceptability from a social point of view.

It is therefore not necessary that the alternatives offer the same level of performance, as long as they have a function and a level of performance that are acceptable to society (even if lower than the most harmful substance). There are specific requirements for the assessment of alternatives in several pieces of legislation, including technical and economic feasibility. The Commission clarifies that it does not intend to change the existing requirements to align them with its Communication.

Conclusions

The EU Communication has no direct legal effect, but will serve as a guide for future legislation, in particular for the revision of REACH regulation and other chemicals legislation. However, the concept of essential use represents a significant change, shifting the attention from risk assessment to hazard and from safety to essentiality. If integrated into EU legislation, this concept will impact the accessibility of many substances and products currently in use.

L'articolo Essential Use Concept according to European Commission proviene da Carmen Sorice Regulatory Affairs.

REACH Regulation and its role in the Packaging Industry

wfbadmin — Thu, 30 Nov 2023 09:27:37 +0000

EC Regulation No. 1907/2006 (REACH) is an important element of European environmental legislation, regulating the use and management of chemical substances.

This legislation, which is essential to protect human health and environment, required new responsibilities to the industry, by shifting the burden of proof regarding the safety of chemical substances from national authorities to manufacturers and importers.

What Reach provides:

– Registration: Manufacturers and importers are required to collect data on chemicals produced or imported in excess of one tonne per year by registering this information in the ECHA (European Chemicals Agency) database.
– Assessment: Potentially harmful substances are evaluated to identify and manage associated risks. Evaluations are conducted by Member States and coordinated by ECHA, with the evaluated substances listed in the Community Rolling Action Plan (CoRAP).
– Authorisation: Substances deemed to be of very high concern (SVHC) are subject to an authorisation process which may restrict or prohibit their use in the EU market without the approval of the European Commission.
– Restriction: This mechanism imposes restrictions on the use, production and marketing of certain harmful substances, regardless of quantity.

Packaging and REACH

According to REACH regulation, packaging falls within the definition of “article” when its shape, surface or design define its function more than its chemical composition.

This means that packaging is subject to the same REACH rules as other articles, including:

Notification to ECHA by the manufacturer or importer for SVHCs (Substances of Very High Concern) released from articles if:
– Exposure to humans or environment cannot be excluded under normal or reasonably foreseeable conditions of use, including disposal;
– the substance is present in such articles in quantities overall exceeding one tonne per producer or importer per year;
– the substance is contained in such articles in concentrations > 0.1% w/w.

Communication by the supplier to the recipient of the article about the presence of SVHC substances, if the substance is present in such articles at a concentration above 0.1 % weight/weight (w/w), and about the information on the substance to allow the safe use of the article.

Communication by the supplier to the recipient of the article about information relating to substances restricted in Annex XVII.

Companies must therefore consider packaging as a separate article with all the related regulatory implications. This requires careful evaluation of the materials used and the substances potentially released to ensure product compliance and safety.

Understanding and implementing the provisions of REACH regulation are crucial for the packaging industry, as they not only affect production and marketing but are also crucial for environmental and consumer protection.

L'articolo REACH Regulation and its role in the Packaging Industry proviene da Carmen Sorice Regulatory Affairs.

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