Strategic Lawering Paris Lyon Bruxelles

Health, Safety, Environment and Regulations

The Soulier AARPI law firm advises and represents a wide range of French and foreign companies operating at all stages of the production and distribution chain in various sectors of activity, including but not limited to, the chemical and agrochemical, pharmaceutical and phytopharmaceutical, life science, energy, automotive, mechanical and electromechanical industries.

soulier-avoctas-sante-securite-environnement

As such, our attorneys assist and defend product and substance manufacturers, producers, distributors, owners and users as well as their professional organizations and representative bodies.

Our Firm provides to these companies and their corporate officers legal advice and representation in connection with all environmental and industrial risk related issues that these market players may face in the conduct of their business operations, as well as with respect to any regulatory issues.

Chemicals and phytopharmaceutical products

Companies operating in the chemical, agrochemical and phytopharmaceutical industries must deal with an increasingly extensive and sophisticated legislation, most of the time derived from EU Directives and Regulations. We offer them legal advice and represent them in both pre-litigation and litigation phases.

In this context, our services are structured around two lines of action:

Legal advice

Soulier assists chemical, agrochemical and phytopharmaceutical companies on the responsibilities and obligations imposed on them by French and EU legislations and regulations.

Our lawyers have acquired in-depth knowledge of the applicable EU texts, including but not limited to: CLP (i.e. Regulation 1272/2008 of December 16, 2008 on classification, labelling and packaging of substances and mixtures), REACH (i.e. Regulation 1907/2006 of December 18, 2006 concerning the registration, evaluation, authorization and restriction of chemicals and establishing a European chemicals agency), PIC (i.e. Regulation 689/2008 of June 17, 2008 concerning the export and import of dangerous chemicals), Regulation on biocidal products (i.e. Regulation 528/2012 of May 22, 2012 concerning the making available on the market and use of biocidal products).

We advise our clients, among which world leaders in the chemical and phytopharmaceutical markets, in connection with the classification, labeling and packaging of their products (substances and/or mixtures), the registration of such products, the preparation and filing of the required safety data sheet, etc.

We also provide strategic assistance with respect to risk assessment and prevention, as well as on all issues related to the publicity, promotion, sale, transport and distribution of chemical, agrochemical and phytopharmaceutical products.

Finally, we also help our clients liaise with competent administrative authorities, such as the DREAL (Directions régionales de l’environnement, de l’aménagement et du logement, i.e. Regional Directorates for Environment, Development and Housing) or the DGCCRF (Direction Générale de la Concurrence, de la Consommation et de la Répression des Fraudes, i.e. Directorate General for Competition Policy, Consumer Affairs and Fraud Control), following investigations and audits carried out in application of the aforementioned legal texts, or in the framework of the interpretation and implementation of French and European legislations.

Litigation

We defend the interests of our clients before administrative and criminal courts in litigations related to the manufacture, placement on the market, import and use of chemical, agrochemical and phytopharmaceutical products.

As such, we represent companies in patent infringement proceedings concerning the parallel import of plant protection products or in the framework of recourses for misuse of authority and claims for indemnification against the State in relation to unusable plant protection products.

Health products and medical devices

Our attorneys have developed a strong expertise in issues related to the placement on the market and sale of health products on the one hand and to the management and disposal of waste from such products on the other hand.

As such, we often assist French and foreign pharmaceutical laboratories, biotechnology companies, manufacturers of medical devices, hospitals, health institutions and suppliers of health products in relation to the placement on the market of their products (administrative formalities and requirements, product certification and standardization, clinical research and trials, consumer information) and provide legal advice on all issues that may arise in the sale process (patent, distribution, import, advertisement and promotion, management of heath data).

Classified facilities

Under French law, an installation classée pour la protection de l’environnement (literally a classified facility for the protection of the environment) is an industrial or agricultural facility that is likely to present a risk or cause pollution or nuisance, especially for the safety or health of local residents. The activities covered by the legislation on classified facilities are set forth in an official list that indicates whether they are subject to the authorization or administrative declaration regime, depending on the level of risks or inconveniences they present.

Our Firm assists operators of classified facilities in complying with their obligations both upon the creation/start of the facility/operations (authorization, registration, declaration, delivery of financial guarantees), the operation of the facility (change in the operating conditions, reporting requirements, etc.) and the discontinuation of their business activities (change of operators or shut down).

We also counsel owners and operators of classified facilities in connection with all issues related to site pollution, site remediation and disposal of waste resulting from the conducted operations and, more generally, on all environmental and criminal liability issues.

We represent our clients in disputes and litigations before administrative courts (e.g. following investigations and audits by the Classified Facility Inspection Bureau, demand letters issued by administrative authorities, administrative sanctions and penalties), civil courts (e.g. abnormal neighborhood disturbances) or criminal courts.

Occupational risks and Technological risks

Our attorneys have a wealth of expertise in the assessment and prevention of occupational risks. They are regularly asked to perform compliance audits, to design, prepare and implement prevention policies and action plans and to manage disputes and litigations concerning these risks (e.g. accident in the work place, occupational disease, inexcusable fault of the employer, etc.) before labor courts and the social security tribunal.

As many of our French and foreign clients operate in the industrial sector in the broad sense of the term, we also have extensive experience in the management of risks associated with the use of production technologies.

Waste Management

Because of the ever-wider application of the principle of producers’ extended liability, our clients, whether manufacturers, importers or distributors of industrial products, must most of the time take care of the collection, recycling or treatment of the waste derived from such products.

As such, we advise the various market players on all issued related to these emerging responsibilities, including from a commercial law and competition law perspective, and to the organization of collective recycling programs through eco-organizations when they do not want to shoulder this burden alone.

Industrial accidents and disasters

Our Firm regularly handles cases concerning air or water pollution, fires or explosions that occurred in particular within industrial sites.

We represent and defend our clients in court-ordered expert investigations and before the civil and administrative courts that must determine the origin and cause of disasters/accidents/damages and the liability of the various parties involved.