REACH Regulation: criteria for metal fasteners

Fasteners: what the REACH Regulation requires

For the purposes of the REACH Regulation (Registration, Evaluation, Authorisation and Restriction of Chemicals), metal fasteners are normally classified as articles, since their function is determined by their shape, surface or design to a greater extent than by their chemical composition.

Registration obligations therefore concern the substances contained in the component, rather than the component itself. Specifically, Article 7(1) requires the registration of substances intended to be released under normal or reasonably foreseeable conditions of use when their total quantity in the articles exceeds one tonne per producer or importer per year, subject to the applicable exemptions.

The composition assessment must consider both the base alloy and the surface coatings, because information on the raw material does not necessarily describe the component after treatment. If a finish applied to an individual screw contains a substance of very high concern (SVHC), the concentration relevant to the associated obligations is calculated by dividing the mass of the substance by the total weight of the coated screw.

This assessment also requires a distinction between substances used in the process and those present in the finished article. Chromium trioxide, included in Annex XIV, illustrates this distinction: its use in treatment must comply with the applicable authorisation regime, whereas the assessment of the component supplied concerns the substances that actually remain in it.

SVHCs: threshold and supply chain obligations

SVHCs (Substances of Very High Concern) are substances identified as being of very high concern because of their effects on human health or the environment. Inclusion in ECHA’s Candidate List triggers specific obligations for suppliers of articles containing them. Lead is a relevant example in metal fasteners: its potential presence in the alloy requires its concentration in the supplied component to be determined.

If a Candidate List substance is present at a concentration above 0.1% by weight, Article 33 of the REACH Regulation requires the supplier to provide the professional recipient with the available information necessary to allow the safe use of the article, including at least the name of the substance.

This information must be provided without a prior request and regardless of the annual quantity placed on the market. Consumers, however, must receive the information upon request, free of charge and within 45 days.

The calculation is based on the individual article, even when it is incorporated into a complex product while retaining its identity. The concentration in a screw must therefore be assessed against the weight of the screw itself, rather than the total mass of the machinery in which it is installed.

Further requirements may apply alongside supply chain communication obligations. For producers and importers, Article 7(2) requires notification to ECHA when, in addition to exceeding the 0.1% concentration threshold, the total quantity of the substance in the articles concerned exceeds one tonne per producer or importer per year, subject to the applicable exemptions.

The obligation to submit information to the SCIP database is separate. It is established by the Waste Framework Directive for EU producers, assemblers, importers and distributors placing articles on the market that contain Candidate List substances at a concentration above 0.1% by weight. This requirement has no minimum tonnage threshold. Retailers supplying directly and exclusively to consumers are excluded, provided they do not also act as producers or importers.

Restrictions and supply documentation

The presence of a Candidate List substance at a concentration above 0.1% does not, in itself, prohibit the component from being placed on the market or used. The restrictions in Annex XVII to the REACH Regulation must be assessed separately, examining the scope of each entry, the conditions specified and any derogations.

Entry 27, for example, sets a nickel release limit of 0.5 micrograms per square centimetre per week for parts intended to come into direct and prolonged contact with the skin. This parameter therefore concerns the release of the substance under the conditions specified, rather than a general limit on the nickel content of fasteners.

Similarly, entry 63 on lead distinguishes between specific applications: these include articles supplied to the general public that, under normal or reasonably foreseeable conditions of use, may be placed in the mouth by children. The applicability of the restriction must therefore be established in relation to the product’s intended use and the conditions and exclusions specified in the entry.

The assessment must be supported by documentation traceable to the supply. Supplier declarations should specify the product codes covered, the materials, the finishes and the Candidate List update considered, identifying any substances present above the threshold.

Composition information forms the basis of the assessment and, where necessary, must be supplemented by tests specifically addressing the substance content or its release.

Declarations and test reports must also be relevant to the configuration purchased: results for a particular alloy or finish cannot automatically be extended to different variants. Changes to the material, coating or production process therefore require a review of the available evidence to assess its relevance to the new characteristics of the component supplied.