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Understanding REACH: The SVHC List and its Impact on Today’s Plating Industry
In a world that is constantly searching for sustainable manufacturing alternatives, the electroplating industry is no exception.
We are living in a historical moment where the efficiency and quality of products must go hand in hand with their compatibility with environmental and human wellbeing standards. For this reason, terms such as 'green' and 'eco-friendly' are increasingly popular across manufacturing industries.
Several institutions have now drawn up various regulations, aiming to encourage the marketing of substances and products that are less dangerous for human health and the environment, to the detriment of substances and finished products that are universally recognized as harmful.
And it is precisely at this point that the most complex challenge arises, that is finding satisfying alternatives to the usual raw materials, which should not only be valid in terms of functionality of the finished product, but also in terms of costs, which should not be disproportionate to the current market demands.
In purely humanistic terms, the decision would be less complex, but as the financial side of things becomes more and more important, it is necessary to consider both sides of the coin.
To this end, the European Chemicals Agency (ECHA), which is committed to protecting the health of citizens and the environment, has developed a complex authorization procedure under the REACH regulation, which aims at weighing up the health-related benefits and the financial implications deriving from the possible substitution of chemical substances on the market.
The authorization procedure is one of the major legislative innovations introduced by REACH. It is dedicated to substances defined as "extremely worrying" (Substances of Very High Concern - SVHC), which have the following dangerous characteristics:
- Substances that meet the classification criteria as carcinogenic, mutagenic or toxic for reproduction (CMR substances) of category 1A or 1B according to Regulation (EC) no. 1272/2008 of the Commission (CLP Regulation)
- Persistent, bioaccumulative, and toxic (PBT) or very persistent and very bioaccumulative (vPvB) substances, in compliance with the criteria set out in Annex XIII of REACH
- Individual substances with a scientifically proven likelihood of serious effects (giving rise to a level of concern equivalent to CMR or PBT / vPvB substances).
The authorization process begins with the identification of the substance as SVHC and its inclusion in the Candidate List of substances, and it ends with the potential addition to Annex XIV of the REACH Regulation.
Each substance included in Annex XIV has a 'sunset date' after which manufacturers, importers or final users will no longer be able to place it on the market or use it without authorization. The authorization request should preferably be submitted by the 'latest application date' provided for that particular substance, thus allowing it to be used, pending any release or denial of the authorization.
The stages of the authorization procedure and the public consultations are as follows:
1. Identification as SVHC
A Member State or the ECHA, following a request from the European Commission, can propose a substance to be identified as an SVHC, by developing a dedicated dossier. The intention to propose a substance for identification as SVHC is then published in the Register of Intentions (ROI), prior to the submission of the proposal, to inform other interested parties in a timely manner.
The proposal is prepared in accordance with Annex XV of REACH and consists of two main parts. The first provides the data and the justification for considering the substance as an SVHC. The second, which is examined during the stages following the identification, includes information concerning the volumes placed on the European market, its use, and possible alternatives to the substance. Within 45 days following the publication of the proposal on the ECHA website, anyone can submit comments or provide further information on the properties of the substance, its uses, and alternatives.
2. Insertion in the Candidate list
If there are no observations that may prevent identification, the substance is included in the Candidate List for authorization.
When, on the other hand, there are comments containing new information or elements contesting the identification of a substance as SVHC, both the proposal and the comments are sent to the Member State Committee, in order to reach an agreement. If necessary, the matter is referred back to the European Commission to take a final decision. The Candidate List is updated twice a year.
3. Inclusion in Annex XIV
The ECHA establishes which substances on the candidate list have priority for inclusion in Annex XIV through the assignment of a score. The criteria for identifying the priority substances are established in art. 58 (3) and refer to danger and exposure.
The ECHA then prepares a draft recommendation, indicating the substances and their priority, and publishes it on its website for a three-month public consultation phase. At this stage, companies can also submit comments of socio-economic nature, to highlight the critical issues of including the substance in Annex XIV. This phase is followed by the evaluation of the Committee of the Member States and the final decision of the European Commission.
4. Application for authorization
Companies that use a substance in Annex XIV and intend to continue using it after the sunset date, must apply for authorization within the latest application date.
The application for authorization requires a huge amount of data to be provided to the Commission which will evaluate its future. The research required to process the data and to submit them to the European Agency calls for very high costs, in the order of tens, if not hundreds, of thousands of euros. For this reason, companies often unite in a single consortium to apply, to join forces, and split the expenses.
On a commercial level, the leading companies that submit the authorization request will consider making their product available to other companies, which will be able to continue using a substance, even though they have not requested authorization, provided that they source their products exclusively from companies that hold an authorization number.
If the European Commission has not yet decreed the outcome of the application on the day of the "sunset date", applicants who have applied within the application date can continue to use the substance pending the final decision. However, companies who have applied to the latest application date must stop using the substance until the decision of the Commission.
The authorization process takes approximately 18 months and requires applicants to submit comments on the draft produced by the ECHA's RAC and SEAC Committees. There will also be an 8-week public consultation session. Finally, the European Commission makes the final decision, granting or denying authorization.
Once granted by the European Commission, authorization is subject to the conditions described in the chemical safety report presented with the application. In addition, the Commission's authorization decision may include supplementary conditions. The authorization holder should continue to work to find safer alternatives after receiving the Commission's decision. The upstream authorization holder, i.e. the manufacturer, importer, or exclusive representative, must include the authorization number on the label before placing the substance itself (or a mixture containing the substance) on the market and must update the safety data sheet (SDS).
Downstream users of a substance included in Annex XIV, but allowed to utilize it by the authorization of an upstream operator, must comply with the conditions of the decision and notify the ECHA of their use of the substance within three months from its first supply. If the downstream users in turn market the substance further down the supply chain, either as such (following repackaging) or in a mixture, they must also submit the authorization information (in the safety data sheet and on the label) to their customers.
It should also be considered that once the authorization has been granted, it does not have a permanent duration. During the examination phase, the Commission identifies a period during which the authorization will remain valid. If there is a need for the importer or user to utilize the substance within 18 months before the authorization expires, they will have to apply again to renew the authorization.
The authorization procedure is certainly a step forward in the long process towards reducing the use of substances that are considered dangerous to human health and the environment, although it is often very difficult to reconcile this objective with the economic demands of the market.
For example, let’s consider boric acid, which is widely used as a pH buffer in nickel baths. The substance has not fully completed the process we have just described. Boric acid is currently considered an SVHC substance since it is toxic for reproduction (H360FD). As described above, however, its inclusion on this list should alert users, because if boric acid is evaluated to be included in Annex XIV, its use would be significantly restricted and prompt companies to apply for authorization. It would be easily conceivable for several companies to join forces to share the costs of the process, but the spotlight should still be put on what the protection measures to be implemented by companies would be, to comply with the more restrictive exposure limits that authorization could impose.
References
ECHA – European Chemical Agency (https://echa.europa.eu/authorisation-process)
Author: Tiziano Laficara, Health and Safety Officer at Technic Italgalvano
About Technic Italgalvano
Technic Italgalvano supplies surface finishing process chemistry for industrial, functional and decorative applications. Our markets include Electronics, Aerospace, Solar, Automotive, Fashion, Furnishings and Decorative applications. Technic Italgalvano provides regional service and support to Europe, Russia and the Middle East. This ISO 9001:2015 facility offers sales and technical assistance for Technic products as well as equipment sales and service.
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