July 2013
abstract
Responsabilité & Environnement
La réglementation REACH
Issue editor:
Serge CATOIRE
Issue 71
Editorial
By Serge CATOIRE
Ingénieur en chef des Mines, Conseil général de l’Économie
A - The technical and institutional environment
REACH: initial successes, future challenges
By Vincent DESIGNOLLE
Chef du bureau des Substances et Réparations chimiques, Direction générale de la Prévention des risques, ministère de l’Écologie, du Développement durable et de l’Énergie
Enacted in 2007, the REACH regulation has laid the basis for reinvigorating EU efforts to prevent chemical-related risks. Its starting point is an unprecedented expansion of knowledge and exchange of information about chemical substances. Affecting several fields of activities by firms and public authorities, this momentum has been a factor of progress since it cuts across organizations. After six years of implementation, the balance sheet turns out to be heavily positive, thus shedding light on the advances made in protecting the environment and human health. We must keep an eye on the implementation of this regulation, which provides for stages in its application: its impact on small and medium-sized firms, the effectiveness of controls, practical provisions for enforcing the authorization procedure, etc. New preoccupations in this field along with the ongoing evolution in our stock of knowledge and in the uses of chemicals will spawn issues that must be addressed to respond to society’s expectations while controlling the impact on firms.
The safety of chemicals: is it possible to harmonize regulations internationally?
By Annick PICHARD
INERIS -Conseillère pour les affaires réglementaires européennes et internationales sur les produits chimiques
In 2006, the European Union performed the daunting task of adopting the REACH regulation for registering, evaluating and authorizing chemicals. This regulation is becoming an international reference mark, as countries draw on it to modify their own regulations in this domain. After presenting the international context and the measures adopted elsewhere, a critical interpretation sheds light on the common characteristics of these regulations and the results of enforcing them. A projection is made into the future…
Methods that provide an alternative to experiments using animals
By Philippe HUBERT
Institut National de l’Environnement Industriel et des Risques
Assessing the toxic effects of physical and chemical substances has, for a long time, required conducting tests on animals. These traditional approaches must be redesigned given both the public’s strong expectations about health and the environment (pesticides, endocrine disruptors) and scientific advances in understanding the effects (low doses, “cocktails”, nonlinear or nonmonotonic effects, etc.). The strong feelings now attached to using alternatives to animal experimentation fit in with evolving cultural perceptions: since the start of the 19th century, society has become increasingly sensitive to the well-being of animals and supportive of animal rights. Alternative methods must satisfy sometimes contradictory expectations. The major issue is to convince the parties involved of the relevance of these methods: validating them in a regulatory context, using them as a tool for industrial screening, subjecting them to scientific investigation and, finally, obtaining public recognition of their credibility.
Evaluating and managing chemical threats to the environment
By Arnaud LAGRIFFOUL
Chef de projets scientifiques à l’Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail (Anses) au sein de l’unité REACH-CLP de la Direction des Produits réglementés
Arnaud LAGRIFFOUL Chef de projets scientifiques à l’Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail (Anses) au sein de l’unité REACH-CLP de la Direction des Produits réglementés REACH places on the firms that make or import chemicals the responsibility for their safe use — with respect to both human health and the environment — in the European Union. Under the old regulations, this liability fell on administrative authorities. REACH has reversed the burden of proof, shifting it onto firms. Guarantees for a safe use must be demonstrated in the records for registering chemicals, since adequate and complete information must be provided. Data of a very good quality are required in order to lay a solid scientific basis for evaluating risks.
The reach regulation: assessing the economic value and environmental impact
By Karine FIORE
Economiste, chef de projets socio-économiques dans le cadre de la mise en œuvre du règlement REACH sur les substances chimiques dans l’unité REACH-CLP de la direction des Produits réglementés de l’Agence nationale pour la sécurité sanitaire de l’alimentation, de l’environnement et du travail (ANSES)
Karine FIORE Economiste, chef de projets socio-économiques dans le cadre de la mise en œuvre du règlement REACH sur les substances chimiques dans l’unité REACH-CLP de la direction des Produits réglementés de l’Agence nationale pour la sécurité sanitaire de l’alimentation, de l’environnement et du travail (ANSES) The tools for calculating the economic value of environmental goods are now almost systematically used to orient the choices of public policy-makers in the field of the environment. They are used as a preliminary to assessing the impact of potential regulations. Since the turn of the millennium, more and more studies in economics have been made on this topic. While invoking the standard precautions about methods of measurement and the interpretations drawn, these studies show that it is possible to quantify to a certain degree the environmental impact, in particular in terms of monetary value, and to place this information at the service of public decision-makers. The REACH regulation on chemicals supports this analytical approach and even provides for applying it in two risk-management procedures: restriction and authorization. Added to the difficulties of assessing the environmental impact is the uncertainty inherent in the properties of chemicals. We must address this intellectual and methodological challenge.
The compliance of small and medium-sized industries with reach
By Pierrick DRAPEAU
Responsable projets REACH, Ecomundo
Compliance with REACH has four dimensions: industrial, commercial, organizational and regulatory. Middle-tier industries do not, in this respect, differ from big groups even though they use smaller volumes of chemicals and mixtures. They do, however, lack time and resources. This makes the task more complicated for them and makes them run considerable financial risks. Two examples are presented herein. First of all, the registration of chemicals, which must take place by 2018 at the latest: small and medium-sized industries must approach registration strategically so as to spread the costs out over time. In particular, they must increase their participation upstream in this process in order to avoid disproportionate costs. Secondly, the traceability of the “substances of very high concern” (SVHC) contained in a company’s products raises questions about the collection and circulation of information all along the supply line. It is a major key for success. Providing support to middle-tier industries is essential for compliance with REACH.
B - Industry
The reach regulation, also an opportunity for reinventing chemical products
By Jean-Pierre CLAMADIEU
Président du Comité exécutif du Groupe Solvay. École Nationale Supérieure des Mines de Paris
Jean-Pierre CLAMADIEU Président du Comité exécutif du Groupe Solvay. École Nationale Supérieure des Mines de Paris and Jacques de GERLACHE Toxicologue, Chargé de la communication du groupe Solvay en matière de Santé, Sécurité et Environnement Thanks to REACH, the users of the chemical industry’s products will be better able to control their uses. Although REACH procedures are long and costly, or even insurmountable (especially for small firms), and even though they are often said to be a brake on economic growth, they also represent a real opportunity for stimulating R&D in the firms that accept to play by the new rules. But this advantage carries a caveat: certain procedures, such as classifying chemicals as “substances of very high concern” (SVHC), must neither be arbitrary nor excessively restrictive with a negative effect on costs and competitiveness at the international level. If this condition is not fulfilled, this unique opportunity for European industrialists to reinvent chemical products will be missed.
REACH: the expected effects reach beyond the chemical industry – a testimony
By Bruno COSTE
Directeur Environnement – Affaires Publiques EADS/Airbus France
The need to adopt at the EU level a deliberate, ambitious policy for managing the risks of chemicals to the environment and human health seems indisputably justified. Several years after its enforcement however, REACH is still far from unanimously accepted. In the current business cycle, it is harder for corporations to put up with the administrative restrictions and costs incurred by applying this regulation. Several industrialists are calling for a review of REACH that would take into account the difficulties they encounter in everyday business.
Applying REACH: the viewpoint of a producer of electricity
By Magali BOIZE
Référent REACh EDF à la Division Production Nucléaire
The European Commission launched in October 2012 a consultation for identifying the ten EU legislative acts that weigh too heavily on small and midsize companies. France reported that REACH figured among the EU regulations that cost the most. This regulation, we are forced to admit, also has an impact on big corporate users of chemicals. The obligations it creates for managing chemicals entail a review of the existing inhouse organization. REACH affects collaboration among all parties in the supply line. The objective at all levels is to implement the appropriate measures for warranting compliance with the regulation while enabling companies to control and maintain their activities.
Mobilization around reach at Saint-Gobain: what benefits for controlling chemical-related risks?
By Guy DUVAL-ARNOULD
Directeur Médical du groupe Saint-Gobain
Guy DUVAL-ARNOULD, Directeur Médical du groupe Saint-Gobain Patrick SÉBASTIEN, Directeur Hygiène Industrielle, Pôle Matériaux Innovants Hélène GASCON Administrateur Outils Maîtrise des Risques Santé and Pierre DELAYEN Directeur Environnement, Hygiène & Sécurité (EHS) du groupe Saint-Gobain What advantages have accrued to Saint-Gobain from applying the REACH regulation for managing, evaluating and preventing chemical-related risks? An approach was adopted that mobilized an inhouse European network before being generalized to operations worldwide, far beyond the scope set by REACH. Thanks to the involvement of R&D in finding a response to the obligations imposed by the new regulation, chemical risks were better taken into account, and prevention was improved owing to the replacement or elimination of substances of very high concern (SVHC) in plans for developing new products or processes. Implementing REACH has also enabled Saint-Gobain to improve, due to the requirement for an exhaustive inventory, its overall approach to risk assessment and control, thus helping it benefit from an improved visibility and traceability of how its chemical products are used. The requirements ensuing from REACH fit in with an approach to sustainable development, “eco-innovation” and “upstream anticipation”. Nonetheless, REACH is but one aspect of the approach to prevention adopted by Saint-Gobain internationally.
Will reach administer the deathblow to europe’s fine chemical industry?
By Frédéric GAUCHET
Président du groupe Minafin
REACH, a unique regulation worldwide, is menacing the future of the French fine chemical industry, which is being battered by the forces pushing up energy costs and taxes, and by the overzealous supervision of administrative authorities. The fine chemical industry illustrates the devious effects of a regulation designed without industrialists but under the sway of an exacerbated “ecologism” and the sacrosanct precautionary principle. Pushing a historically well-controlled industry toward less precautionary countries beyond the EU’s borders will cause more pollution and higher unemployment in Europe, and ultimately debase the quality of life that regulators wanted to improve.
C - Risk-perception
Reach: “come on, one more effort!”
By Sophie FLECKENSTEIN
Chargée de mission du réseau Santé Environnement de France Nature Environnement
Sophie FLECKENSTEIN Chargée de mission du réseau Santé Environnement de France Nature Environnement and Christian SCHAIBLE Chargé de mission du réseau Risques et Impacts industriels de France Nature Environnement Even as cases of chronic illnesses and environmental pollution are proliferating around the world, notably in Europe, REACH is still the best tool for regulating how chemicals are used. Despite the important advances made thanks to it, this regulation has several shortcomings, not to mention the delays in implementing it. A little more effort is needed to make REACH the best tool for fighting against chemical pollution and a driving force in sustainable innovation!
New risks for health
By Francis GLEMET
Pharmacien industriel, lanceur d’alerte en Santé-Environnement
The use of chemicals spawns a growing number of illnesses. The first part of this article deals with multiple chemical sensitivity (MCS), a little-known chronic medical condition affecting nearly 11% of the population in industrialized lands. The second part focuses on endocrine disruptors and the way that REACH takes them into account.