Regulatory Developments

ECHA Publishes List Of Pending Article 95 Applications and Other Recent BPR Developments

April 2, 2015 PRINT

ECHA Publishes List Of Pending Article 95 Applications:The European Chemicals Agency (ECHA) announced in a March 31, 2015 press release, that to increase transparency ahead of the September 1, 2015, deadline for the compliance with Biocidal Products Regulation (BPR) Article 95, it has published a list of all pending Article 95 applications. The list contains applications for which the ECHA has not yet taken a decision, and ECHA will update it regularly. ECHA will synchronize its publication with the list of relevant substances and suppliers. ECHA states: "It is important to note that the presence of a company for a given active substance/product type/role on the list of pending applications does not guarantee that the corresponding application will be successful and that the company will ultimately be included in the 'Article 95 list.'" More information is available in ECHA's press release, ECHA publishes list of pending Article 95 applications.

Roadmap Published For Defining Criteria For Identifying Endocrine Disruptors: Under Plant Protection Product Regulation (EC) 1107/2009 (PPPR) and BPR, "the co-legislators empowered the Commission to establish scientific criteria to identify substances with endocrine disrupting properties." This Roadmap, published by DG ENV and DG SANCO in June 2014, defines criteria for identifying endocrine disruptors and is closely aligned with the guidance issued by the World Health Organization International Program on Chemical Safety (WHO IPCS) (2002). The EP and Council requested the EC to establish a horizontal hazard-based scientific criteria so it could be used in other EU legislation as well, namely Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), Regulation (EC) No. 1223/2009 on Cosmetic Products, and the Medical Devices regulatory framework and Water Framework Directive 2000/60/EC.

The Roadmap introduces four policy options: the baseline, i.e., no policy change, the interim criteria set in BPR and PPPR continue to apply; hazard identification based on the WHO IPCS definition; the WHO IPCS definition completed with categories based on strength of evidence; or completed with the introduction of potency. The three options for regulatory actions are the following: no policy change; considering further risk-related aspects; and considering further socio-economic aspects. To gather information on the potential economic impact of the above scenarios, a public consultation started in 2014 and concluded in January 2015. The EC released in February 2015 the non-confidential responses submitted on-line during this consultation and is expected to issue a detailed report on the consultation and possibly organize a stakeholder conference in summer 2015. The impact assessment will be conducted by the EC through mid-2016. The anticipated schedule for final criteria is a proposal in late 2016, adoption in early 2017, and entry into force in the second quarter 2017.


 
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