« As Europe’s biggest economy and home to its largest national chemical industry (and the world’s biggest chemical company), Germany plays a key role in the implementation of REACH and other EU chemicals legislation, as well as in discussions on future policy directions.
It is one of the most frequent producers of proposals for the restriction or mandatory classification of substances and is a major contributor to the work on substance evaluation, which is divided up among member states and the details for which are published in the Community Rolling Action Programme (Corap).
This work, together with broader policy development, enforcement and awareness raising, is largely shared between three federal agencies (see box), which also work closely with state-level agencies, Echa and the other member states.
So how does this happen? What will be their main chemicals-related projects in the next 12 months, and what are their key priorities related to REACH and other chemicals legislation? In response to these questions, we received a joint written response from Baua, the BfR and the UBA. »
« Baua’s chemicals office (division 5) is the German Competent Authority for REACH. It is responsible for the general execution of REACH tasks including planning, coordination, administration and legal issues.
Scientific evaluation is mainly carried out by experts in the assessment units of BfR, UBA and division 4 of Baua. These are specialised experts covering the fields of toxicology, ecotoxicology, risk assessment as well as exposure assessment for consumers, workers and the environment, respectively.
The responsibilities are divided as follows:
– the BfR is responsible for human hazard assessment and risk assessment for consumers;
-Baua’s hazardous substances and biological agents office (division 4) deals with occupational safety and health; and
-the UBA covers environmental assessment.
The German authorities establish a confidential joint work plan that is regularly updated. For this purpose, so-called “coordination meetings” take place regularly, where the authorities agree on their priorities for both REACH processes and substances. But information on intended activities can be found on Echa’s website in the sections on the public activities coordination tool (PACT) and the Corap, as well as on the webpages of the German national helpdesk.
Although tasks under REACH and CLP are clearly divided between the German assessment units, close cooperation and coordination of all activities is crucial. In many cases, one unit relies on work carried out by another: for example, the “T” criterion for environmentally relevant persistent, bioaccumulative and toxic pollutant (PBTs) substances could be fulfilled by a human health endpoint such as reproductive toxicity or specific target organ toxicity – repeated exposure (Stot Re). In such a case, close cooperation between the UBA and the BfR would be necessary and consistency throughout documents would have to be ensured.
The German work programme currently focuses on substance evaluation and aims to assess 11 substances per year. These were selected according to national priorities (for example, on perfluorinated compounds) as well as from the annual screening programme, organised by Echa. Find an overview of the German Corap substances here.
The German authorities are also actively contributing to risk management processes under REACH. In the framework of the substances of very high concern (SVHC) Roadmap 2020, German experts are participating in the screening and coordination activities organised by Echa.
Since 2014, about ten to 15 substances per year have been screened for further actions and, if justified, a risk management option analysis (RMOA) is carried out. For specific classes of substances (for example, suspected carcinogens, endocrine disruptors (ED) – environment/PBT-/vPvB-substances) RMO analysis is preceded by a hazard assessment and/or activities to propose harmonised classification. Examples of substances that are currently intended to be analysed in this way are nickel sulphides and three alkyl phenols. Concerned companies are encouraged to provide further relevant information via a consultation procedure.
As a result of the RMOA, a substance might be taken forward for further regulatory action either under REACH or under other legislation. Under REACH, SVHC identification (in most cases, followed by authorisation) or restriction are possible options.
For SVHCs, the main focus currently lies on PBT/vPvB substances and those that could fall under the scope of REACH Article 57(f) – for example, sensitisers, Stot Re substances or endocrine disruptors in the environment. Recently submitted SVHC dossiers for two UV stabilisers demonstrate vPvB properties, and currently, work is proceeding on two UV adsorbents that might act as endocrine disruptors in the environment (see Echa registry of intentions).
The focus of activities is shared among each of the German authorities. For instance, due to the initiative of the BfR, the concentration of carcinogenic polycyclic aromatic hydrocarbons (PAHs) was successfully restricted in consumer products.
With regard to the environment, several substance groups are in the focus of our work, especially with regard to potential PBT/vPvB-properties: alkylphenols, phenolic-benzotriazoles and per- and polyfluorinated chemicals. For example, perfluorooctanoic acid (PFOA), its salts and related substances prompted the UBA, in cooperation with Norwegian authorities, to propose a restriction on their uses.
Current activities also include a restriction proposal for the group of diisocyanates. These substances are respiratory sensitisers and might cause occupational asthma if not handled correctly. »
Article of Geraint Roberts
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