McKenna Long & Aldridge (MLA) counsels clients on a wide range of business law, and regulatory and trade matters relating to environmental activities in the European Union (EU). Our reputation in this area in part stems from our long-time presence in Brussels where trend-setting EU environmental regulations such as REACH have been adopted.
We represent a wide range of European, American, and Asian clients and advise them on product regulation issues and product defense strategies pertaining to their business operations in the EU. In addition to guiding clients through the maze of EU regulations, we often lobby EU and member state institutions on our clients’ behalf before legislation is adopted and, when necessary, represent their interests in related litigation before the European Court of Justice, the European Court of First Instance, and various member state courts.
Our European environmental practice covers both EU and member state laws and includes:
MLA is extensively involved in advising and representing clients on matters arising under existing EU chemicals legislation, including REACH. The chemicals practice concentrates in particular on representing clients in the field of product regulation, advising them on issues pertaining to the classification, packaging, and labeling of chemical substances and mixtures, including safety data sheets, marketing and use restrictions, authorizations under REACH, workplace regulations, and product liability related issues, as well as questions relating to the free movement of goods and parallel imports.
We manage several REACH consortia and counsel our chemical clients also on the competition law aspects of REACH.
MLA has created an on-line tool for issuance of REACH letters of access for its consortia and other clients. To access this page, please visit http://www.mlalaw.eu/.
Building upon MLA’s experience in the field of U.S. pesticide regulation, our Brussels office has established a reputation of excellence in this area, advising numerous manufacturers on the European re-registration program laid down by EU Directive 91/414 and product authorization under Directive 98/8 (biocides). We manage and advise several task forces under both programs.
We are involved in a series of matters involving almost all of the 23 product types listed in the Biocidal Products Directive 98/8, as well as scope and borderline issues and in particular concerning the EU food, cosmetics, and chemicals legislation. We advise many individual companies and task forces in connection with data submission, data protection, and procedural, regulatory, and scientific related issues (in cooperation with TSGE). We assist clients in making notifications and in preparing complete dossiers for including active substances in Annex I (IA or IB) of the Biocidal Products Directive, and also help them in negotiating and drafting task force and data sharing/compensation agreements, in compliance with applicable EU competition law requirements.
We are experienced in all labeling issues, borderline product assessment, and product liability and recall questions. We have assisted several clients in obtaining GMO and novel food authorizations and advise on food contact regulation related matters.
Our Brussels office acts as regular counsel to major garment and sporting goods companies on regulatory matters. This includes: setting up supplier restricted substances lists and related advice on supply agreements; advice on multi-language labeling, size labeling, and flammability warnings; setting up a database on product recall legislation in a multitude of jurisdictions; advice on product recalls; advice on high-tech garments; counseling on “waste” classification of textile waste; and advice on use of biocides in garments.
EU Regulatory Engagements
Our attorneys advise clients in other fields of environmental, health and safety, and consumer protection law, including water and air pollution control; permitting; waste management, shipment and disposal; packaging and packaging waste; biotechnology; worker health and safety; ecological labeling; environmental auditing requirements/due diligence reviews in connection with the purchase and sale of companies in the EU; car and battery recovery schemes; toys; personal protective equipment; medical devices; and climate change/emissions trading matters.
In 2006, we designed and negotiated the first multi-sectoral Social Dialogue Agreement on the good handling of silica, protecting more then 2 million workers, that was praised as a model to follow.
- Creation and management of several REACH consortia, including styrene, ethyl benzene, and unsaturated polyester resins.
- Lobbying and advice on pharmaceutical products exemption under REACH, including applicability of exemption to various categories of pharmaceutical ingredients and exported products.
- Advocacy and advice on scope of Annex IV and V REACH exemptions, including minerals, frits, glass and LPG.
- Setting up REACH compliance schemes for several companies in the organic chemicals and consumer goods businesses.
- Drafting of Only Representative agreements for REACH.
- Memoranda on liability issues for Only Representative arrangements under REACH.
- Advice on scope of REACH regarding international sea transport.
- Advice on scope of REACH in relation to customs warehousing.
- Review of safety data sheets.
- Legal opinions on article versus substance classifications under REACH.
- Advice on genetically modified enzymes.
- Representation of several task forces for registration of active ingredients under Directives 91/414 and 98/8.
- Numerous borderline products advice on biocides versus food contact material, food processing aids, food additives, pharmaceutical products etc.
- Complaint on teat dips.
- Numerous successful and pending applications for authorization of novel foods and novel food ingredients under Regulation 258/97.
- Drafting of report for European Commission on stakeholder submissions and recommendations on revision of Novel Food Regulation 258/97.
- Advice on borderline product issues of novel foods vs food additives.
- Advice on infant formulae.
- Legal opinions on various food packaging compliance and contamination issues.
- Product recalls.
- Advice on new European Commission proposed legislation on food information.
- Advice on introduction of voluntary nutrition information system of major food service company.
- Advice on health and nutrition claims.
- Advice on printing inks.
- Monitoring of nutrition legislation in 27 EU member states and setting up of annual report regarding same.
- Advice and monitoring of iodized salt national legislation in many EU member states.
- Advice on minced meat legislation and meat origin requirements.
- Advice and advocacy on isoflavones.
- Advice and advocacy on authorization of pathogen reduction treatments for poultry.
- Product Labeling Guide for 30+ countries for textiles, footwear and sporting equipment.
- Advice on product recalls.
- Advice on introduction of new products including high-tech garments.
- Advice on biocides in textiles and scented garments.
- Advice on re-use and recycling of garments and footwear, and establishing company recycling schemes.
Other EU Regulatory Engagements
- Advice on indoor air fresheners.
- Advice on WEEE and RoHS, including on self-reporting of RoHS violations.
- Advocacy on introduction of restrictions and essential use exemptions for PFOS.
- Development of strategy and negotiation of first EU level multi-sectoral social dialogue agreement on the good handling of silica.
- Advice on mercury phase-out strategy and mercury recycling for chlor alkali industry.
- Various complaints about the introduction of national legislation for packaging bag taxes and national textile taxes.
- Advice on emissions trading.
- OHS counseling.
- Advice on GMO clinical trials.
- Advice on introduction of bird feed in several EU member states.
- Licensing of new type of electronic equipment in several countries.
- Advice on revision of RoHS Directive, in particular hazardous substance exemptions.
- New EU Biocidal Products Regulation 528/2012 coming into force in September 2013: Article 95 obligation will be applicable to all operatorsMay 3, 2013
- The climate change legal framework currently in force in the European Union (“EU”) essentially aims to achieve three targets by 2020 (so-called “20-20-20 targets"). The targets, to which EU leaders initially committed at a political level in March 2007, have for the main part been addressed in a binding legislation package adopted in April 2009.
- New EU Market Abuse Regulatory Framework in the Energy Sector: A Fragmented Legal Regime for Climate ChangeDecember 28, 2011The European Parliament and the Council of the European Union has formally adopted Regulation (EU) No 1227/2011 on wholesale Energy Market Integrity and Transparency (“REMIT”), allowing for a uniform and simultaneous applicability of its provisions across all EU Member States.
- Energy Performance Contracting
- Brussels Office Overview
- Climate Change: Latest legal and policy developments within the European Union: “20-20-20 Targets” (Slides)