Ales Bartl has a broad experience in European Union (EU) product regulatory law, including Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) regulation, the Classification, Labelling, and Packaging (CLP) regulation, Biocidal Products Regulation (BPR), medical devices, electronic products, and general product compliance and product safety. He advises on regulatory compliance of a broad range of products marketed in the EU and represents clients before EU and national competent authorities on compliance and enforcement issues, including product withdrawals and recalls.
Ales also represents clients before the Court of Justice of the European Union and the Board of Appeal of European Chemicals Agency.
Prior to joining Keller and Heckman, Ales interned at the European Commission (EC) and worked for almost ten years as an EU regulatory associate at two international law firms in Brussels.
Representative Matters
- Represented a client in a legal challenge to the listing of a substance as a Substance of Very High Concern (SVHC) in the EU General Court
- Represented a trade association in an appeal of a REACH Restriction before the European Court of Justice
- Represented a client in challenging a dossier evaluation decision before the ECHA Board of Appeal
- Represented clients in several substances and dossier evaluation procedures before ECHA
- Advised on withdrawal of a consumer product containing REACH-restricted phthalates
- Drafted data-sharing agreements related to new biocidal active substances and biocidal product families
- Provided assessments of regulatory status of several borderline products between medical device/cosmetic products/biocidal products
- Provided legal management of a REACH consortium for a substance with increased scrutiny by ECHA because of complicated substance identity profile (reaction product) and potential hazards
- Provided contract drafting (SIEF and consortia agreements, only representative agreements, intra-company agreements for REACH management)
- Conducted data-sharing disputes
- Advised on classification and labeling and harmonized classification procedures, including advocacy
- Advised on substances of very high concern (SVHC) in articles and on ECHA substances of concern in products (SCIP) database of articles containing SVHC
- Advised on applicability of REACH authorization requirement in the supply chain
- Provided advocacy related to a derogation request from a REACH restriction
- Advised on the best pathways for authorization of biocidal products
- Advised on and advocated with the Swedish authority KEMI related to the approval of a new active substance based on silver
- Provided defense of Biocidal Products Regulation (BPR) enforcement case in France
- Advised on Restriction of Hazardous Substances (RoHS) (applicability, exemption procedures, interface with REACH)
- Advised on applicability of the Single Use Plastics Directive (SUPD)
- Worked on recipe requirements pursuant to specific legislation (baby food, chocolate products, organic food, etc.)
- Assisted with applicability of standards and sector-specific product regulations relevant to electronic products
