Articles

Reference:  http://guidance.echa.europa.eu/authorisation_en.htm

Substances of very high concern will be gradually included in Annex XIV of the REACH Regulation. Once included in that Annex, they cannot be placed on the market or used after a date to be set (the so-called “sunset date”) unless the company is granted an authorisation.

Substances of very high concern (SVHC)

Substances of very high concern include substances, which are:

• Carcinogenic, Mutagenic or toxic to Reproduction (CMR) classified in category 1 or 2
• Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB) according to the criteria in Annex XIII of the REACH Regulation, and/or
• Identified, on a case-by-case basis, from scientific evidence as causing probable serious effects to humans or the environment of an equivalent level of concern as those above e.g. endocrine disrupters

Why and how do they need to be regulated?

These substances have hazardous properties of very high concern.  It is essential to regulate them because the effects they can have on humans and the environment are very serious and often irreversible. There is no tonnage threshold for a substance to be subject to authorisation.

The authorisation mechanism consists in an in-depth assessment.  Its outcome is then thoroughly discussed before appropriate decisions are taken.

How will the authorisation process look like in practice?

The authorisation process consists of four steps. Industry has obligations in the third step. However, all interested parties have the opportunity to provide input in steps 1 and 2.

Step 1: Identification of substances of very high concern (by authorities)

Substances of very high concern can be identified on the basis of the criteria previously described. This will be done by Member State Competent Authorities or the Agency, (on behalf of the European Commission), by preparing a dossier in accordance with Annex XV. Interested parties can comment on substances for which a dossier has been prepared. The outcome of this identification process is a list of identified substances, which are candidates for prioritization (the “candidate list”). The list will be published and periodically updated by the Agency, probably not before end 2008.

Step 2: Prioritization process (by authorities)

The substances on the candidate list are then prioritized to determine which ones should be subject to authorization. Interested parties are invited to submit comments during this process. At the end of the prioritization process, the following decisions are taken:

• Whether or not the substance will be subject to authorisation
• which uses of the included substances will not need authorisation (e.g. because sufficient controls established by other legislation are already in place)
• the “sunset date” by when a substance can no more be used without authorisation.

Step 3: Applications for authorization (by industry)

Applications for authorisation need to be made within the set deadlines for each use that is not exempted from the authorisation requirement. They must include among others:

• a chemical safety report covering risks related to those properties that caused the substance to be included in authorisation system (unless already submitted as part of the registration)
• an analysis of possible alternative substances or technologies.  Including, where appropriate, information on research and development foreseen or already in progress to develop such alternatives.

If the analysis of alternatives reveals that a there is a suitable alternative, the applicant must submit a substitution plan, explaining how he intends to replace the substance by the alternative. The suitability of available alternatives is assessed taking into account all relevant aspects, including whether the alternative results in reduction of overall risks and is technically and economically feasible.

Reference: http://guidance.echa.europa.eu/reach_processes_en.htm

Pre-registration (Link)

Manufacturers and importers must pre-register substances that are already on the EU market (so-called phase-in substances), if they want to benefit from transitional arrangements that allow registering them at a later stage. Pre-registration also enables registrants to share data with other registrants and avoid carrying out redundant tests. The pre-registration period is limited from 1 June 2008 to 1 December 2008.

Registration (Link)

REACH requires manufacturers and importers of chemical substances (≥1 ton/year) to obtain information on the physicochemical, health and environmental properties of their substances and use it to determine how these substances can be used safely. Each manufacturer and importer must submit a registration dossier documenting the data and assessments to the Agency.

Evaluation (Link)

The Agency will perform dossier evaluation to assess testing proposals made by the registrant or to check that the registration dossiers comply with the requirements. The Agency will also co-ordinate substance evaluation, which will be conducted by the Member States to investigate chemicals of concern.

Authorisation (Link)

Authorisation will be required for the prioritized substances of very high concern (SVHC) that are included in Annex XIV.

Companies applying for authorisation will have to demonstrate that risks associated with uses of these substances are adequately controlled or that the socio-economic benefits from their use outweigh the risks.

Applicants will also have to investigate the possibility of substituting theses substances with safer alternatives or technologies, and prepare substitution plans, if appropriate.

Restriction (Link)

The European Union can impose restrictions and prohibit or set conditions for the manufacture, placing on the market or use of certain dangerous substances or group of substances when unacceptable risks to humans or the environment have been identified.

Classification and labeling inventory (Link)

A classification and labeling inventory will be developed from notifications submitted by industry on substances classified as dangerous (including those below 1 ton/year) and from information on classification and labeling included in registration dossiers.

Communication in the supply chain (Link)

Suppliers of substances must pass on information on the health, safety and environmental properties and safe use of their chemicals to their downstream users (via a Safety Data Sheet or other means). Downstream users may only use substances classified as dangerous or which are persistent, bioaccumulative and toxic (PBT and vPvB) if they apply risk management measures identified on the basis of exposure scenarios for their use.

Enforcement (Link)

Enforcement of REACH towards companies is a task for the Member States.

The Member States shall maintain a system of official controls, inspections.  In national legislation they shall set effective, proportionate and  dissuasive penalties in national legislation.

In order to co-ordinate the enforcement of REACH, a Forum for Exchange of Information (“Forum”) will be established within the Agency.

Reference:  http://echa.europa.eu/chem_data/authorisation_process/candidate_list_en.asp

Candidate List of Substances of Very High Concern for Authorization

Substances that are included in the Candidate List have been identified as Substances of Very High Concern (SVHC). These substances may have very serious and often irreversible effects on humans and the environment. Substances on the Candidate List may subsequently become subject to authorisation by decision of the European Commission.

Substances are added to the Candidate List by ECHA. The inclusion of a substance in the List may have legal obligations on companies. These obligations are linked to the listed substances:

• On their own
• In mixtures
• Present in articles

The Candidate List will be regularly updated when more substances are identified as SVHC.

Reference: http://echa.europa.eu/en/information-on-chemicals/candidate-list-substances-in-articles

An article is the legal term under REACH for any object that has been given a specific shape, surface or design so that it can be used for a specific purpose (e.g. manufactured goods such as cars, textiles, electronic chips).

Guidance on requirements for substances in articles

Deciding What Is An Article Under REACH (page 21)

"Article means an object which during production is given a special shape, surface or design which determines its function to a greater degree than its chemical composition;" (REACH, Article 3(3)).

In a general understanding, an article is an object composed of one or more substances or preparations given a specific shape, surface or design. It may be produced from natural materials, such as wood or wool, or from synthetic ones, such as polyvinyl chloride (PVC). Substances or preparations may be added to give an article its special properties. Most of the commonly used objects in private households and industries are articles, e.g. furniture, clothes, vehicles, books, toys, kitchen equipment, and electronic equipment. In order to determine whether or not an object fulfils the definition of an article under REACH sometimes a deeper assessment of an object’s function and its properties are needed.

Borderline in the sequence of processing natural or synthetic materials to final articles (page23) When materials are processed, there is a certain point in the processing, where they change from being a substance/preparation to being an article. In some cases there may be doubts on when exactly this transition occurs. The following approach should be seen as decision help in support of the application of the article definition when deciding on these types of cases. The following steps may be taken:

As a general principle, the article definition should be applied, which is a two-step process:

1. Determine the function(s) of the material by assessing the technical features of the material in relation to the intended function by the seller as well as the buyer of the material.
2. Decide on what is more relevant for the function, the shape/surface/design or the chemical composition

If you can unambiguously conclude that the shape/surface/design are more relevant for the function than the chemical composition, the (form of the) material that you are assessing is an article. If the shape, surface or design is of equal or less importance than the chemical composition, it is a substance or preparation.