Ales Bartl advises Keller and Heckman Partners and clients on regulatory compliance of a broad range of products marketed in the EU. Ales primarily focuses on REACH, Classification, Labelling, and Packaging (CLP), Persistent Organic Pollutants (POPs), biocidal legislation, food law, medical devices, electronic products and product and food safety.
Ales represents clients in various procedures before the European Chemicals Agency (ECHA) and European Food Safety Authority (EFSA). Ales also represents clients before EU and national competent authorities on compliance and enforcement issues, including withdrawals and recalls of unsafe or non-compliant products.
Prior to joining Keller and Heckman, Ales interned at the European Commission and worked for almost ten years as an EU regulatory associate at two international law firms in Brussels.
- Represented clients in several substance and dossier evaluation procedures before the European Chemicals Agency
- 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 product
- 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 SVHC in articles and on ECHA 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
- Advice and advocacy (with the Swedish authority KEMI) related to approval of a new active substance based on silver
- Provided defense of BPR enforcement case in France
- Advised on RoHS (applicability, exemption procedures, interface with REACH)
- Advised on applicability of the Single Use Plastics Directive
- Worked on recipe requirements pursuant to specific legislation (baby food, chocolate products, organic food…)
- Assisted with applicability of standards and sector specific product regulations relevant to electronic products