In Europe the ECB maintains lines of actionThe problem is not so much funding that landIt is consistent in addition to the landscapeThe unsuccessful will be many including in the ranks of the French banks pretends to be surprised a great connoisseur of the folderA wonderful starting point for this Odyssey KrugAfter all RTE and ERDF are not in a financial emergencyLast Rodeo succeededThe film is quite pessimisticAppointments may be made with the judges before ChristmasCompanies that have significant reserves of cashDecember 13, 2006, the regulation concerning the registration, evaluation and authorization of chemicals, as well as the restrictions applicable to these substances was finally adopted otherwise known by the acronym Reach. This innovative text is not simply the 41st European production on substances chemical but rather the founding text of chemistry at the European, "regulations" as direct applicability is attached in the 25 countries of the European Union is the evidence.
Reach is therefore based on pharmaco-regulatory guidance for management of chemical risks, i.e. "accountability" of the company to their management. This management must be accompanied by the implementation of scientific and toxicological analysis tools and data. Reach cut into analytical segments is designed, to facilitate the access of SMEs - SMIs to regulatory and scientific data. To date, very few companies in the sector France chemistry began to deal with this European regulation instead of Nordic companies or the Benelux. This lack of interest in France for toxico-regulations favourable to the development of new molecules is worrisome to many titles: failure of innovation, loss of speed, and therefore market, certain sectors, vision of texts and its legal implications. Wait and see appear once again the key words in French companies. Also, and to resume the dialogue between the regulation and the entrepreneurial dynamism, it is urgent to transform stress factors of innovation and qualitique tools.
Reach is based on four pivotal, recording, evaluation of the substances or products, authorisation for their placing on the market and information between professionals. The role of the toxicologist in the implementation of this regulation is clear. Indeed, throughout the life cycle of chemicals must be taken into account in the assessments. It is therefore essential and urgent to focus on the work of expertise to propose to establish appropriate development strategies.
SME - SMIs do not always have in their teams of toxicologists specialized in the field. Indeed, the risk management exceeds far the information contained in safety data sheets. It is now, in addition, a "technical file" and a "chemical safety report" with the assessment and management measures of risks that need to be concerned. The establishment of files for registration must be the most complete possible the risk of the substance or product in case of marketing.
Multiple risks
Toxicological data, analyze, interpret them to leave a frame that will serve as a starting point to potential complementary analyses are work to carry out meticulously. Regulation deadlines are on a toxicological scale, very short. That is why, now, to focus on the issues of this Regulation may become development for SMEs - SMIs.
However, Reach also includes a component on the liability of the company in the risk assessment. That is why, in addition to the purely scientific aspect, it is important for SMEs - SMIs to take into account the legal aspect in the development of records and in relations with all of the supply chain. On all the links indeed weigh new binding obligations: the manufacturer, importer, downstream user or yet the Distributor. Follows a multiplication of legal risks at all levels: transfer of the burden of proof that a substance is not dangerous for public authorities to industry and strengthening of the duty of care; duty of information and protection of data and industrial property rights; worsening of the liability and insurance coverage extended; operation of consortia and right of the antitrust. Penalties for violation can achieve, based on this law of competition, 10 of the global turnover of the undertaking. The place of the jurist, and including its role in the drafting of contracts expected to manage risks listed, will be to find valued.
Innovative toxico-legal issues, diverse and aggravated risks and a reduced schedule, all of the chemical industry must therefore anticipate and act now to transform this new regulation in quality management tool.