29 April 2016
Action Plan for Evaluating Harmfulness of Substances Updated
On 22 March 2016, the European Chemicals Agency (ECHA) announced that it has adopted the Community rolling action plan (CoRAP) update for 2016-2018. The plan is for 138 substances suspected of posing a risk to human health or the environment to be evaluated over the next three years. The list of 138 substances consists of 54 newly-selected substances and 84 substances from the previous plan published on 17 March 2015.
Hong Kong manufacturers may wish to familiarise themselves with the substances put forward for evaluation, as once they are added to the Candidate List, different obligations will apply to suppliers of the substances concerned, as well as of articles and mixtures containing them. The term articles includes commonly used consumer goods such as clothing and domestic appliances.
The substances are selected for their potential persistent, bio-accumulative and toxic (PBT) properties, their very persistent and very bio-accumulative (vPvB) properties, their suspected endocrine disruption or their carcinogenic, mutagenic and reprotoxic (CMR) properties. For each selected substance, ECHA has drafted a document justifying the need for its evaluation and its suspected risks.
For instance, under the CoRAP update for 2016-2018, Germany will evaluate the chemical, 1,3-dioxlane. This substance was selected for its suspected PBT/vPvB properties; as a potential endocrine disruptor; for its suspected mutagenic and reprotoxic properties; its consumer use; and wide dispersive use.
1,3-Dioxolane is a solvent used in formulations, in production processes and as a reactant itself. Hong Kong businesses involved with, among others, garments or electronics may know that the substance has many applications in the textile industry, metal working and electroplating, in the production of lithium batteries, gasoline and petroleum.
Additionally, the CoRAP update for 2016-2018 has proposed that the substance methacrylamide be evaluated by Sweden this year. This substance was selected due to concerns about the harm workers may suffer from its exposure.
Methacrylamide is used as a raw material for polymerized compounds. It is used in the manufacturing of textiles, such as latex, leather and fur. It is also used in the production of chemicals and fine chemicals.
From 22 March 2016, Member States have twelve months to evaluate the 39 substances that have been listed for 2016 alone, to clarify whether their use poses a risk to human health or to the environment. Member States use the substance evaluation process under the REACH Regulation (Articles 44 to 48) that allows for clarification of such potential risks. Where necessary, the evaluating Member State will prepare a draft decision for requesting relevant further information from registrants, to clarify the suspected risks.
Following the evaluation process, each Member State will make a conclusion on the risks of the substances. A Member State may conclude that the risks are sufficiently under control with the measures in place or it may propose alternative risk management measures to be implemented throughout the EU. Possible measures may be restrictions, identification of substances as of very high concern, harmonised classification or another action outside the scope of REACH. Each Member State must submit its draft decision on each substance evaluated in 2016 to ECHA before 22 March 2017. The final decision on each substance will be published on the ECHA website.
It is important for Hong Kong traders to bear in mind that the chemicals that are evaluated may be added to the so-called Candidate List. When a substance is added to the Candidate List, certain legal obligations arise for EU manufacturers, importers and distributors. Thereafter, the use of the substance may eventually become restricted or prohibited.
Suppliers of articles which contain substances on the Candidate List in a concentration above 0.1%, have to provide sufficient information to allow safe use of the article to their EU customers (downstream recipients but not consumers); or upon a consumer’s request, within 45 days of the receipt of such request. This information must contain, as a minimum, the name of the substance.
In addition, producers or importers of articles are obliged to notify ECHA if their article contains a substance on the Candidate List. This obligation applies if the quantity of the substance in the article is above a concentration of 0.1%. Only very limited exemptions apply.
Suppliers of substances on the Candidate List have to provide their customers with a safety data sheet (SDS). If the substance is in a mixture, then pursuant to specific conditions the supplier of the substance must provide their downstream customers with an SDS.
Please click on the following for the CoRAP 2016-2018, which lists all 138 substances to be evaluated.