REACH Regulation and its characteristics

The REACH Regulation is a frequently discussed standard for the manufacture of elastomer formulations and their use.

We thought it would be a good idea to write an article answering common questions such as: what is REACH, what does ECHA mean, what is SVHC for, and how does REACH affect me?

Read on to learn more about the REACH Regulation and all its features.

What is the REACH Regulation?

The REACH Regulation is the European legal framework that defines the aspects to be taken into account by any natural or legal person wishing to incorporate chemical substances from 1 tonne per year into the Community market (controls, registrations, permits and authorizations).

To this end, on June 1, 2007, Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorization and Restriction of Chemical Substances and Mixtures came into force. (Registration, Evaluation, Authorisation and Restriction of Chemicals - REACH).

The enforcement of REACH and the penalties to be applied in case of non-compliance are the responsibility of each member state of the European Union within its territory.

What is the purpose of the REACH Regulation?

The objective of the REACH regulation is to contribute to the protection of health and the environment from the risks of the manufacture, placing on the market and use of hazardous chemical substances and mixtures.

Definition of concepts included in the REACH Regulation

In order for you to better understand the terms used in the REACH environment, we will briefly define some concepts:

• - Substance: is any chemical element and its compounds in their natural or manufactured state, including the additives necessary to preserve their stability and any impurity deriving from the manufacturing process used (excluding solvents).
• • Articlerefers to an object with a special shape, surface or design that determines its function, regardless of its chemical composition.
• • IntermediarySubstance: is any natural or legal person established in the European Community who uses a substance or substances, and who is not a manufacturer or an importer.
• • MarketingThe supply or making available of an article, against payment or free of charge, by a third party. Importation is considered as commercialization.
• • Recipient of an articleThe final consumer is an industrial user or a distributor to whom an article is supplied. The final consumer is excluded.
• • Supply chainThe term "marketing" means any actor involved in the commercialization of mixtures or articles.
• • SVHCSubstances of Very High Concern: acronym for Substances of Very High Concern and the name given to a list of substances identified according to the criteria set forth in the Regulation. REACH.
• • ECHASVHC: acronym for the European Chemicals Agency which manages and publishes the SVHC list and the SVHC candidate list (Candidate List). Once a substance is added to this list, obligations are immediately imposed on manufacturers and importers to declare the substances present.
• • Article 33Article of the Regulations REACH concerning the obligation of manufacturers and importers of articles or products to notify their customers of the presence of substances of very high concern in their products if they exceed 0.1 % by weight, as well as to provide instructions for their safe use.
• • SCIPdatabase on substances of concern present in articles as such or in complex objects (products) and established under the Waste Framework Directive (WFD).Waste Frame Directive - WFD). SCIP is an acronym for Substances of Concern In articles as such or in complex objects (Products). SCIP ensures that information on articles containing substances on the candidate list is available throughout the life cycle of products and materials, including the landfill phase.

Which chemicals are affected by REACH?

In the slang of ECHA, a hazardous substance is labeled as a “Substance of Very High Concern” (SVHC).Substance of Very High Concern - SVHC). Prior to labeling in this way, the substance must be temporarily added to the so-called Candidate List (Candidate List).Candidate List), pending the processing of the authorization for its use (annex XIV of REACH).

REACH involves the creation of the European Chemicals Agency (European Chemicals Agency - ECHA) based in Helsinki. This organization is responsible, among many other things, for defining the hazardousness of a chemical substance. The regulation REACH affects all chemicals except for those that are in the form of a chemical explicitly excluded.

In addition, restrictions on substances, mixtures or articles are decreed in Annex XVII of REACH.

Who is obliged to comply with the REACH regulation?

Often, one wonders how or in what way the Regulation may affect him or her. REACH. From manufacture to purchase by the End User of any article and/or substance, the responsibility affects the entire supply chain.

The manufacturer must notify if its article contains any substance of very high concern and, according to Annex II of REACH, The final user is the end user, who is the ultimate recipient of the safety data sheet.

Since the candidate list is dynamic, it may happen that some of the components of the formulation of a substance have been included in this list, when previously it was not. This situation is resolved as above, being the responsibility of the manufacturer to notify the supply chain of this circumstance.

How to comply with REACH provisions?

A manufacturing company, in order to comply with the provisions of REACH, must identify and manage the risks associated with the substances it manufactures and markets in the European Union. It must demonstrate how to use such substances safely and must communicate the risks involved and preventive measures to the parties concerned.

The REACH Regulation covers the following processes:

• - Registration (title II): the manufacturer must register any hazardous substance manufactured/imported in quantities equal to or greater than 1 ton/year, according to the procedure established by ECHA.
• • Evaluation (Title VI): the risks to health and the environment shall be assessed for that hazardous substance, as established by ECHA.
• • Authorization (Title VII): for the substance of interest, a use authorization must be applied for in accordance with ECHA. At the end of the authorization procedure, it is ensured that this substance can be progressively replaced by a less hazardous substance(s) when economically and technically viable alternatives are found.
• • Restriction (title VIII): if applicable, ECHA may limit or even prohibit the use of such a substance.

We hope this article has been of interest to you. If you have any questions, please contact us at contact our specialists in the field.