As we draw closer to the 12th version of the Candidate List (CL), we realize that continuous monitoring of CL holds tremendous benefits for the Suppliers or Product manufacturers. In a broader view, the monitoring process allows them to steer ahead of competition in the European market.
For diligent monitoring, Suppliers need to be aware of the dynamic nature of REACH CL. Since the Registration process for REACH and ECHA’s Evaluation are ongoing, new SVHCs are being identified continuously. The CL currently gets updated twice in a year. As soon as the substances are listed on the CL, Suppliers are required to inform their customers and in some cases to ECHA (if authorization is needed), about the presence of these substances.
Suppliers and other duty holders are required to continuously monitor and maintain their product’s compliance status up-to-date.
ECHA, the competent authority or an agency of EU member state can propose a substance to be identified as a Substance of Very High Concern (SVHC) to European commission by preparing a dossier. If identified, the substance will be added to the Candidate list.
Prior to the formal CL announcement, ECHA will publish the proposal of a substance to be identified as an SVHC in order to provide advance information to industries and other stakeholders. After publication of the proposal member states, related bodies, industry experts can share their views related to the use and risks/properties of the proposed substance or its alternatives. The proposals and comments will be forwarded to the Member State Committee for further consideration, before the release of CL. If the committee does not reach a unanimous agreement, the matter will be referred to the European Commission. If no comments are received, the substance will be included in the CL directly.
What should a Supplier/Manufacturer do?
The inclusion of a substance in the Candidate list creates legal obligations to companies manufacturing, importing or using such substances.
As per ECHA, if a company has to perform their operations with a product in EU, then the product must be compliant to REACH regulation. The compliance depends on the presence or absence of SVHCs in their product after the sunset date and also they have to fulfill their obligations in REACH as a duty holder. Continuous monitoring of Candidate list is required to determine the presence or absence of SVHCs.
The duty of all suppliers is to inform their customers about the inclusion or non-inclusion of SVHCs and the safe use of products since REACH aims to improve protection of human health and the environment from the risks of chemicals.
Suppliers need to provide information to their customers if an article contains a substance listed on the Candidate list in a concentration exceeding 0.1 % weight/weight. This duty is described in Article 33 in REACH, and applies as soon as a substance has been included in the Candidate list.
Article 33 in REACH:
- Applies to all suppliers of articles that contain more than 0.1% of any substance on the Candidate List.
- Requires the supplier to provide recipients of the article with sufficient information to allow safe use of the article. As a minimum, the name of the substance has to be provided.
- Requires the supplier to provide such information to consumers on request, within 45 days from the date of the request.
If a company has to sell their products in EU after the sunset date then it should not contain any of the published SVHCs more than 0.1% weight/weight. After sunset, the Suppliers are not allowed to use or market the particular substance, unless they have been granted an extension of time-limited authorization by the European Commission. If granted, The suppliers can continue to use the Candidate list substance as an exception till the next review date, assigned by ECHA. Within the stipulated time, the Suppliers are expected to find a substitute substance. In case if ECHA finds the substitute before the review date the Supplier will have to immediately discontinue the usage of the Candidate List substance and switch to the alternative provided. In certain cases, it is possible that EC can choose to allow or disallow some usage of the CL substance depending on its risk level. In case the identified substance is found to be of unacceptable risk, the Commission can choose to reject extension and add it to Annex XVII of REACH.
Benefits of following CL regularly
* Helps to maintain the REACH-compliance on the entire EU market.
* Allows maintaining the competency in the market.
* Helps in taking early prevention on limitations/bans on the substance.
* Allows providing clear information on contents of products to supply chain.