Seal of approval - EU regulations on hazardous substances
Strict EU regulations mean any use of hazardous substances may be subject to authorisation. Dr Neil Hunt from The REACH Centre explains the process and the decisions affected companies will need to make.
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What defines a substance as hazardous? While it is widely appreciated that chemicals such as cyanide are dangerous to human health in very small quantities, at some stage we must ask ourselves if the benefits outweigh the risks of using it at all. Strict EU regulations mean any use of hazardous substances may be subject to authorisation by the European Commission (EC) via a system concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).
One stated principle of REACH is to ‘assure that the risks from substances of very high concern are properly controlled, and that these substances are progressively replaced by suitable alternative substances or technologies where these are economically and technically viable’. The tool used to enforce this principle is authorisation.
While EU chemical manufacturers, importers and users will probably be familiar with REACH through the registration process, authorisation has some fundamental differences. The primary difference can be summarised as ‘the substance is registered, the use is authorised’. Authorisation places the focus on the user of the substance, not the producer, to ensure permission for a specific use. This may mean that actors who have only had a fleeting interaction with REACH will be required to become fully immersed in the regulations. There is also no minimum weight limit on the usage of a substance for authorisation to be pertinent, so any user of the substance may be affected by authorisation.
If the EC believes that a substance is so hazardous it should be phased out from the EU, it will be placed on the Annex XIV of REACH. This means the substance cannot be placed on the market, imported or used within the EU after a specified ‘sunset date’, unless that use has been authorised. Fourteen substances are currently listed on Annex XIV, a number that is set to increase.
Is authorisation needed?
Any chemical declared a Substance of Very High Concern (SVHC) and placed on the Candidate List of REACH (Annex XV) may be subject to authorisation in the future. After considering recommendations from the European Chemicals Agency (ECHA), the EC decides whether the use of a substance requires authorisation and those that do are placed on Annex XIV. The process leading to authorisation is well-defined, so any concerned company will be able to judge the likelihood of a substance requiring authorisation well in advance.
The length of time between inclusion on the candidate list and placement on Annex XIV varies from substance to substance, depending on its hazards and breadth of use, but it is generally more than than a year.
When determining whether or not an application is needed, companies should note that authorisation only applies to substances and mixtures, and not to articles – that is, products whose use is defined by shape rather than chemical composition. However, users of such articles should be aware that the quality and price of the article may alter because of authorisation affecting its manufacturing process. Uses already covered by other regulations will not be subject to authorisation, for example cosmetics, medicines and biocides. Specific exemptions for use may be applied for during the consultation periods. These requests will be assessed by ECHA, with the final decision of whether to include the exemption in Annex XIV made by the Commission.
Who needs to apply?
Authorisation can be granted to any actor in the supply chain. Who the authorisation is granted to will influence which other parties in the supply chain are also covered. Where a supplier may be granted authorisation for a number of uses of a substance, any downstream user may use it for those specific purposes if bought from the applicant. A downstream user may also apply for authorisation for their use, and this will cover the immediate supply of the substance to them. A joint application can be made by multiple actors wanting to split the cost of the work. However, with no formal mechanism in place to allow cost sharing, this will have to be negotiated between the interested parties.
A potential applicant will now need to ask themselves some further questions depending on their position in the supply chain:
- What are our customers’ uses and do we want to include them in an application?
- Are our suppliers going to apply for authorisation for our use?
- Do we want to do a joint application, who with and who will pay for it?
Once the identity of the applicants has been settled, the requirements for the application must be investigated.
Structuring an application
An authorisation may be granted through two routes:
- Proof that there is adequate control of the process, to ensure the substance poses minimal risk to human health or the environment. This method is only available to substances with a threshold concentration below which there are no adverse effects to health.
- Proof that the social and economic advantages of continued use of the substance outweigh the negative impacts to human health and the environment, as demonstrated through a socioeconomic analysis.
If the application cannot provide evidence of one of these standards, it will not be successful and the specific use of the substance will be prevented after its sunset date.
Each route must contain defined sections, the requirements for which are wide ranging and will require input from a variety of experts. To provide the breadth of data required for either route, the entire supply chain will need to be consulted.
As applications for authorisation are required to be submitted at least a year and a half before the sunset date, applicants may be left with as little as 18 months to complete their submission after the substance has been placed on Annex XIV. If no work is done prior to this, there will be little time to agree cost structures for a joint application, contact the supply chain and organise a suitable project team.
Hence before these issues are even addressed, it is worth asking some fundamental questions:
- Will it be economically viable to apply for authorisation?
- Are alternatives to the SVHC available and can we switch to them now?
- Can we change our product portfolio to avoid SVHCs?
Rules and resources
Once it has been decided that an application will be progressed, several issues require careful consideration – mainly legalities, labour and cost.
Applicants will need to engage with their entire supply chain to access information relevant both to the analysis of alternatives and the socio-economic analysis. But with EU competition law legislating against the communication of any market-sensitive information between competitors or members in a supply chain that would compromise free competition in the sector, the potential for clashes between the two are self-evident. What’s more, an applicant may not wish for details of their substance’s use to be disseminated throughout the supply chain. One solution is to recruit an independent third party to compile and collate any sensitive data on the applicant’s behalf. Of additional concern is ECHA’s requirement to make public some aspects of any applications it receives, although to what extent is still a subject of debate.
To ensure legalities are met, an applicant should ask themselves the following questions:
- What resources do I require for an application?
- How will I avoid breaching competition law?
- Should I use a third party?
- What parts of the application do I want to remain confidential?
Next to consider is a suitable taskforce. The complexity and depth required for an application will require a multi-skilled project team, although the detail required depends on how much is needed to present a justifiable conclusion. How ECHA and the Commission will assess applications is not yet clear, raising uncertainties as to the time and cost involved – although ECHA has estimated that an application will take 12–24 months to complete. The basic fee for an application is €50,000 (£39,100), with discounts for SMEs and supplements for the inclusion of extra uses or applicants.
In recruiting the appropriate taskforce, applicants will need to consider:
- how much work can be performed in-house
- who the work can be outsourced to
- how costs will be divided between applicants and the supply chain
The introduction of authorisation for the use of some SVHCs in the EU will no doubt raise issues crucial to business continuity for the entire manufacturing sector. Taking the appropriate steps in planning and managing applications will ensure the process is kept as cost-effective and hazard-free as possible.