• Bisphenol A: The highest profile of the four is bisphenol A, which was proposed by France and will be added because of its toxic properties affecting reproduction. It’s widely used in the manufacturing of polycarbonate and epoxy resins that are then used as packaging material for a wide range of products.
• PFDA: The perfluorinated chemical PFDA (nonadecafluorodecanoic acid) and its sodium and ammonium salts. These were proposed by Sweden, due to their critical qualities concerning reproduction and persistent, bioaccumulative and toxic (PBT) properties. They have been used as plasticiser, lubricant, surfactant, wetting agent and corrosion inhibitor. They have also been commonly detected in various water and stain-resistant textiles.
• 4-HPbl: 4-heptylphenol, branched and linear (4-HPbl), this was proposed by Austria, due to its endocrine-disrupting properties for the environment. The phenol, heptyl derivative of this substance is registered as a monomer. Uses of the resulting polymers include in lubricants and greases in vehicles or machinery.
• PTAP: 4-tert-pentylphenol (PTAP), proposed by Germany, due to its endocrine-disrupting properties for the environment. It is used in the production of phenolic resins and lacquers. Also used in the production of ethoxylated resins, some of which are used in oilfield applications. Other uses can be found in cleaning/washing agents, surface active agents and paints. It’s also used in consumer products like adhesive, sealants, coatings and paints, thinners and paint removers.

With these 4 substances categorized as SVHCs the total number of substances on the list will be 173. The other two substances that are under consideration are:

• 4-tert-butylphenol (PTBP), also proposed by Germany, is an endocrine disruptor. This chemical is a resin that is mainly used in adhesives for leathers and rubbers. It can be found in leather shoes, handbags and belts. It is also used in varnish and lacquer resins, motor oil additives, printing inks, fibreglass products, plywood, masonry sealants and some commercial disinfectants.
• Trimellitic anhydride (TMA), proposed by the Netherlands, is a respiratory sensitizer. It is primarily used in the synthesis of plasticizers for PVC resins, while smaller amounts are used as a reactant in wire and cable insulation enamels and polyester resins for powder coatings.

CONCLUSION:

Regulations put into place will have to be adhered by all the entities that trade with the EU, this implies that any company that produces or imports articles containing any of the 173 substances will be responsible for complying with all the necessary rules established by the mandate.

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• ECHA received two dossiers in accordance with Annex XV to REACH for substances from Member States (Sweden & Netherlands), which in their opinion meet the criteria of substances of very high concern (SVHCs) set out in Article 57 of REACH.
• On 2 March 2015, the Agency invited all interested parties to submit comments on the Annex XV dossiers, as stated in Article59 (4) REACH.
• The public commenting period for all substances ended on 16 April 2015.
• In accordance with Article59 (5) REACH, the deadline for Member States or their agency to comment on the identification of the substances as SVHCs was 4 May 2015.
• Post the deadline ECHA received comments on the identification as SVHCs for the proposed substances. Thus, according to Article59 (7) of REACH the dossiers related to these substances were referred to the MSC.
• The MSC unanimously agreed via written procedure, which closed on 29 May 2015, that the proposed substances met the criteria set out in Article 57 of REACH for identification as SVHCs.
• Therefore, according to Article59 (8) of REACH, ECHA included these substances in the CL on 12 June 2015.
• In accordance with Article 59 (10) REACH, now the revised CL is published on ECHA’s website on 15 June 2015 by the decision ED/39/2015.

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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 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.

• 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.

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