Authorisation and substitution

A novelty in REACH, compared to previous EU chemicals legislation, is that substances may be subjected to an authorisation requirement. The substances that can qualify for authorisation requirement are so-called ‘substances of very high concern’ (SVHCs). These are substances meeting the criteria for classification as carcinogenic, mutagenic, or toxic for reproduction (CMR); PBT or vPvB substances; and substances identified on a case-by-case basis for which there is scientific evidence of probable serious effects that cause an equivalent level of concern, as with CMR or PBT/vPvB substances. (Art 57.)

If a SVHC is listed in Annex XIV (‘the Authorisation List’) it becomes subject to authorisation. The adding of a substance to that list is a two-step procedure, the first step of which is its inclusion on the ‘candidate list for eventual inclusion in Annex XIV’ (the ‘Candidate List’). The Commission may ask ECHA to prepare a dossier for substances which in its opinion meet the SVHC criteria. Any Member State may also prepare such a dossier and forward it to ECHA.2³ If ECHA does not receive or make any comments within a certain time after having made the dossier public, it shall include the substance on the Candidate List. When comments are made, a Member State Committee will need unanimous agreement on identification of the substances as a SVHC. If there is no agreement the matter is referred to the Commission and a decision is made in accordance with the so-called examination procedure.^{[1] [2]} It is hence individual Member States or the Commission that initiate the inclusion of a substance on the candidate list. (Arts 58 and 59.)

Even though it is a candidate list for eventual inclusion in Annex XIV, the inclusion on the list in itself has some significant implications. Producers and importers of articles must notify ECHA if a substance included in the list is present in those articles in quantities totalling over one tonne per producer or importer per year and above a concentration of 0.1 per cent weight by weight. The Court of Justice has made clear that manufactured objects that meet the criteria for being classified as articles do not cease to be articles when assembled to form a complex product. It is only if an article becomes waste or ceases to have a shape, surface, or design which is more decisive in determining its function than its chemical composition that it stops being an articled The concentration threshold thus applies to each individual article rather than to the total weight of any complex product, such as a car or a mobile phone, of which the article may have become a part. If exposure to humans or the environment during normal or reasonably foreseeable conditions of use including disposal can be excluded, it suffices to supply appropriate instructions to the recipient of the article. (Art 7.)

The supplier of an article containing a listed substance in a concentration above 0.1 per cent weight by weight must also provide any industrial or professional user, or distributor, of the article with sufficient information to allow for its safe use. The duty only covers information available to the supplier, and as a minimum the name of the substance. However, final consumers need only be provided with this information if they request it. (Art 33.) Substances remain on the candidate list, and these obligations continue to apply, even if they are eventually included in Annex XIV.

There are clear signs that inclusion of a substance on the candidate list acts as a strong driver of innovation and substitution^⁶ The decision to include a substance has in some cases been challenged as being contrary to the principles of equal treatment and proportionality^

The decision to include a substance in Annex XIV, and thereby make it subject to authorisation, is made in accordance with the examination procedure. ECHA is to recommend priority substances to be included. Priority shall normally be given to substances with PBT or vPvB properties, wide dispersive use, or high volumes. ECHA also invites all interested parties to submit comments on its recommendations. (Art 58.)

At the time of writing, Annex XIV contains thirty-one substances which are either already subject to authorisation or will become so no later than January 2019.

A substance that has become subject to authorisation may not be placed on the market for a use or used unless the use for which it is placed on the market or for which the actor uses the substance has been authorised. Any manufacturer, importer, or downstream user of a substance may apply to ECHA for an authorisation. Applications may be made for the applicant’s own use(s) or for uses for which she intends to place the substance on the market. Based on opinions by ECHA’s ^{[3] [4] [5]}

Committees for Risk Assessment and Socio-economic Analysis and comments from the applicant, it is for the Commission to grant or refuse the authorisation in accordance with the examination procedure.

An important aim of the authorisation system, in addition to controlling the use of SVHC, is that such substances should be progressively replaced by suitable alternative substances or technologies where these are economically and technically viable. To that end, applications for authorisation shall include an analysis of the alternatives considering their risks and the technical and economic feasibility of substitution. Where the analysis shows that suitable alternatives are available, a substitution plan, including a timetable, shall be included.

An authorisation shall be granted if the risk to human health or the environment from the use of a substance arising from its intrinsic properties is adequately controlled. When granting the authorisation, the Commission shall take into account all discharges, emissions, and losses known at the time of the decision. However, this does not apply with respect to substances meeting the criteria for classification as CMR, PBT, or vPvB substances and substances identified on a case-by-case basis, for which there is scientific evidence of probable serious effects that cause an equivalent level of concern as with CMR or PBT/vPvB substances. For such substances, and for any other substances whose risk to human health or the environment is not deemed to be adequately controlled, an authorisation may only be granted if it is shown that socio-economic benefits outweigh the risk to human health or the environment arising from the use of the substance and if there are no suitable alternative substances or technologies. Such a decision requires consideration of the risk posed by the uses of the substance, the socio-economic benefits arising from its use, and the socio-economic implications of a refusal to authorise, as well as an analysis of the alternatives, and available information on the risks to human health or the environment of any alternative substances or technologies. When assessing whether suitable alternative substances or technologies are available the Commission shall take into account the technical and economic feasibility of alternatives for the applicant as well as whether the transfer to alternatives would result in reduced overall risks to human health and the environment.

Authorisations shall be subject to a time-limited review and shall normally be subject to conditions, including monitoring. The review period and any monitoring arrangement shall be specified in the authorisation. Notwithstanding any conditions of an authorisation, the holder is required to ensure that the exposure is reduced to as low a level as is technically and practically possible.

In cases where the substance is placed on the market, authorisation for a particular use may have been granted to the immediate downstream user rather than to the manufacturer, importer, or downstream user herself. A downstream user may use a substance provided that the use is in accordance with the conditions of an authorisation granted to an actor up her supply chain for that use. Exemptions apply to the use of substances in scientific research and development and to uses in plant protection products and biocidal products in accordance with relevant EU legislation. (Arts 56, 60, 62, and 64.)

• [1] By 2015 Germany, France, the Netherlands, Austria, and Sweden had been most active insubmitting such dossiers. D Romano and T Santos A Roadmap to Revitalise REACH (EuropeanEnvironmental Bureau, 2015) 11.
• [2] 24 See further Regulation (EU) No 182/2011 of the European Parliament and of the Council layingdown the rules and general principles concerning mechanisms for control by Member States of theCommission’s exercise of implementing powers [2011] OJ L55/13, Art 5.
• [3] Case C-106/14 FCD andFMB ECLI:EU:C:2015:576, paras 53—54.
• [4] 26 Romano and Santos A Roadmap to Revitalise REACH (n 23) 10.
• [5] See, eg, Case T-96/10 Rutgers Germany and Others ECLI:EU:T:2013:109.