Key Benefits:
Mr. President,
La La La La La La La La La La La La La La La La La La La La La La La La La La La La La La La La La La La La La La Act No. 2008-757 of 1 August 2008 on environmental liability and various provisions for adaptation to community law in the field of the environment has empowered the Government to take all measures to adapt:
- the legislative provisions relating to chemicals and biocides in Title II of Book V of the Environmental Code;
- the legislation on the chemical risks of Title I of Book IV of Part IV of the Labour Code;
the criminal provisions of Part IV of Book VII of Part IV of the Code;
and provisions of Article L. 5141-2 of the Public Health Code,
the following community texts:
― Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the registration, assessment and authorization of chemical substances, as well as the restrictions applicable to these substances (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 of the Council and Regulation (EC) No. 1488/94 of the EEC
- Regulation (EC) No. 842/2006 of the European Parliament and the Council of 17 May 2006 on certain fluorinated greenhouse gases;
- Regulation (EC) No 850/2004 of the European Parliament and Council of 29 April 2004 concerning persistent organic pollutants and amending Directive 79/117/EEC;
- Regulation (EC) No 304/2003 of the European Parliament and Council of 28 January 2003 concerning the export and import of dangerous chemicals;
– Regulation (EC) No. 2037/2000 of the European Parliament and Council of 29 June 2000 on substances that deplete the ozone layer;
- Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 on the marketing of biocide products, Regulation (EC) No 1451/2007 of the Commission of 4 December 2007 concerning the second phase of the ten-year programme of work referred to in Article 16, paragraph 2, of the Directive 98/8/EC of the European Parliament and the Council on the marketing of biocide products.
Many of the provisions of title II of Book V of the Environmental Code are now either obsolete or in contradiction with Regulation (EC) No 1907/2006 REACH (acronym of "Registration, Evaluation and Authorization of CHemicals") which has profoundly redesigned the law applicable to chemical substances. It replaces more than forty directives and completely re-merges the three directives and community regulations that defined the harmonized control of chemicals in Europe (Council Directive 67/548/EEC "classification, packaging, labelling of hazardous substances"; Directive 1999/45/EC of the European Parliament and the Council "classification, packaging, labelling of hazardous preparations"; Council Directive 76/769/EEC "Restriction on the market and use of certain substances
Furthermore, it is necessary to be able to sanction in a harmonized manner the breaches of the above-mentioned regulations governing specific substances and chemicals.
I. ― Regulation (EC) No 1907/2006 REACH is based on four procedures:
- the registration of chemical substances produced and imported on European Union soil to more than one ton per year;
― the assessment of registration files, test proposals and substances;
- authorization of substances of extreme concern;
― the restriction of use for certain substances.
Chemical substances covered by REACH are both chemical synthesis and natural synthetic substances, as such or in a preparation or article. However, some substances are excluded from the REACH application field.
1° Given the large number of substances currently on the market, the "existing" substances must be registered according to a schedule spanning eleven years, based on danger criteria and tonings on the market. These substances were pre-registered between June 2008 and November 2008. Voluntary registrations, prior to the settlement deadlines, are of course possible. Finally, REACH regulations provide exemptions to the registration requirement for certain substances or particular uses.
It will be up to each producer/importer of chemicals to file a registration file with the European Chemicals Agency, created by the REACH Regulation. This file will include the hazards of the substance, its uses and the risk management measures to be implemented as soon as the substance is produced or imported beyond a certain tonnage. It will provide the necessary data to assess the risks associated with the use of these substances. Following these assessments, where risks are identified, the use and marketing of the substances concerned may be restricted or prohibited.
2° As part of REACH, it is up to manufacturers and importers of substances to prove that the risks associated with the substances they produce or import are validly controlled, while this burden has so far been up to the public authorities.
In addition, the REACH Regulation introduces an information system inside the producer's supply chain to the user and vice versa. The Safety Data Sheet (SDS) is the central communication tool on risk and risk management measures to be adopted throughout the supply chain.
3° The authorisation procedure is to prohibit the use of the most worrying substances, unless authorized on a case-by-case basis, following a request for a particular use by a company. To this end, the latter must produce a record in which it details the use it wishes to make of the substance, the reasons that are based on the compelling nature of the substance's use for the purpose and the research efforts undertaken to find a substitute. In this sense, each company, alone or with others, will have to use alternative products, if any. This procedure applies regardless of the quantity of substance produced or imported and may therefore concern unregistered substances produced in quantities less than 1 ton/year. It is estimated that approximately 1,500 substances of extreme concern may be subject to an authorization procedure.
4° Finally, the restriction procedure, already in force within the framework of the previous legislation derived from Council Directive 76/769/EEC "Restriction on the Market and Use of Certain Hazardous Substances and Preparations", always prohibits uses with uncontrolled risks, regardless of the quantity produced or imported. Provisions relating to the restriction procedure derived from Directive 76/769/EEC are included in Appendix XVII of the Regulations. This annex will be applicable from 1 June 2009, and Directive 76/769/EEC will be repealed with effect on the same date.
Decisions on granting or refusing authorizations and decisions on restrictions are the responsibility of the European authorities.
II. ― Since June 1, 2008, the provisions for the notification of new substances, currently contained in section 1 "New Substances Declaration" of Chapter I, title II of Book V of the Environmental Code, transposing, inter alia, Directives 67/548/EEC and 76/769/EEC, are in place in the new REACH Regulation. As a result, sections 1 and 2 are amended to reflect the fact that all substances are now subject to REACH regulations.
Sections 3 " Control and recognition of offences", 4 "Administrative sanctions" and 5 " Penal sanctions" are amended to allow the control of the application of REACH regulations and the suppression of breaches and offences against these regulations. The aim of harmonizing the chemical police leads to the re-engineering of the sanctions already provided by the environmental code that suppresses breaches of other European chemical regulations.
Article 126 of the REACH Regulation requires Member States to define a sanctions regime applicable to violations of the provisions of this Regulation. Many breaches do not justify criminal sanctions and administrative sanctions are effective in preventing or punishing the commission of certain facts. For this reason, this Order provides for a number of administrative measures to suppress breaches of or remedy the consequences of chemical legislation. It does not provide for criminal penalties only for offences against the fundamental pillars of REACH, namely the failure to register or authorize, non-compliance with restrictions or the use of a substance, unless notified to the agency, outside the scope of its registration. These offences are described as offences and punished by two years imprisonment and a fine of €75,000. This Order also provides that failure to comply with the obligations of the Security Data Sheets Regulations is an offence punishable by three months' imprisonment and a fine of €20,000.
In order to allow for the repression of violations of Regulation (EC) No 850/2004 on Persistent Organic Pollutants (POPs) and Regulation (EC) No 842/2006 on certain fluorinated greenhouse gases, the mention of these regulations was added to Article L. 521-21 defining penal sanctions. Any offence against these regulations constitutes an offence punishable by two years' imprisonment and a fine of €75,000.
The implementation of REACH also involves an amendment to the labour code, including provisions for the marketing of substances and preparations and the reporting of hazardous preparations for toxicoviglance to the National Research and Safety Institute.
III. ― This Order includes four articles in addition to the Implementing Article. The first mentions the changes to Book V of the Environmental Code. The second changes the labour code, the third changes the public health code. The fourth provides a valid transitional provision until June 1, 2009, which is not intended to be codified.
The I of section 1 of this Order is a clarification of the scope of Chapter I of Division II of Book V of the Environmental Code (Chemical and Biocide Products), and states in particular that the REACH Regulation applies to the manufacture, marketing and use of substances such as or contained in preparations or articles, REACH also defining what is a substance, preparation of the regulations and REACH. The possibility for the administrative authority to grant exemptions for the interests of the defence is recalled.
Section 1 II and III propose a new drafting of sections L. 521-5 and L. 521-6 to take into account the procedures for the registration or notification of substances under the REACH Regulations, which now apply to all chemical substances. However, the new wording of Article L. 521-5 maintains the obligation of manufacturers and importers to disclose data to the administrative authority for the purpose of facilitating controls. Information on developments is not mandatory if the importer or manufacturer has already forwarded it to the European Chemicals Agency. The requirement to be made available to the administration of samples of substances or preparations is repealed in the light of the heavy hardship it represented for economic operators without making a real benefit to the controls.
The new wording of section L. 521-6 allows the administration to prescribe valid prohibition or restriction measures in the national territory where an emergency action is essential to protect human health or the environment in accordance with sections 49 and 129 of the REACH Regulations. This section will also prescribe such measures for the carriage of substances by rail, road, river, marine or air ―not covered by REACH regulations ― as well as for the manufacture, marketing or use of substances as long as the requirements are not harmonized at the community level.
Part IV of section 1 repeals the I and II of section L. 521-7 which are no longer applicable since the entry into force of the REACH regulation on June 1, 2007. The addition of the mention, in the last paragraph of this article, of the European Chemicals Agency is necessary as this agency is now responsible for collecting and evaluating the registration data of substances.
Section 1 V provides for a new drafting of section L. 521-8 and proposes to delete provisions for the assessment of substances under regulation (EEC) No. 793/93 of March 23, 1993 concerning the assessment of existing substances, which has been repealed by the REACH Regulations since June 1, 2008 (section 139 of the Regulations). In addition, there is a link with the various assessment, restriction and authorization procedures provided for in REACH regulations to which section L. 521-8 relates. This provision is necessary in the event of further assessment of substances or proposals for restrictions or prohibition of substances.
The VI deletes, in Article L. 521-9, the provisions relating to safety sheets, now harmonized under the REACH Regulation.
Section 1 VII and VIII are intended to bring sections L. 521-10 and L. 521-11 of the Environmental Code into line with the REACH Regulation.
The IX, X, XI and XII of Article 1 detail the conditions for the conduct of inspections, sampling and analysis of the samples of chemicals and their possible seizure. Authorization for chemicals control officers is in place to communicate with each other the information and documents collected during a control to ensure better coordination and effectiveness of controls.
Article 1, XIII and XIV, recognizes the special prerogatives of labour inspectors by ILO Convention No. 81 on Labour Inspection in Articles L. 521-16 and L. 521-17.
Article 1, Article 1, XIV, extends the scope of controls to all the regulations of community chemicals referred to in this title and provides for the pre-emptive procedure for administrative sanctions defined in the XV. The three-month period for the submission of possible comments to a breach reported in a report by the administrative authority is now the maximum time limit that may be proposed by the administrative authority.
The XV of Article 1 replaces Article L. 521-18 with an article listing administrative sanctions that may be applied to breaches of chemical legislation. Their deterrent aspect in the event of non-compliance with the requirements of a stay is strengthened. Specific measures are provided in the event of non-compliance with a requirement for non-compliance with the main obligations imposed by REACH procedures.
The XVI of Article 1 amends Article L. 521-19 to specify the conditions under which administrative sanctions provided for in the XV may apply.
Article 1, 17, amends Article L. 521-21 to draw up a list of criminal penalties applicable in particular to breaches of the main pillars of REACH. The XVI to XXVI are articles of editorial modification and repeal.
Section 2 I states that the REACH community system replaces the national chemical reporting system that was first marketed after September 18, 1981.
Section 2 II is intended to replace the terms of the labour code with those used in REACH regulations.
Section 2 III is intended to review the scope of exemption cases to the requirement to report to a registered body some of their products for medical, curative and preventive purposes due to the new registration procedures for new substances introduced by the REACH Regulations.
Section 2 IV is intended to delete the reference to section L. 4411-3, introducing the REACH regulation within section L. 4741-9, which defines the quantum of sanctions for offences committed by a person other than the employer or its representative.
Section 3 of the Order aims to clarify the boundary between the field of veterinary drug and biocide products for products that claim external pest control with lethal action on the parasite.
Section 4 provides for a transitional provision, which will not be codified, allowing for the adoption at the national level of restriction measures until the entry into force of Title VIII of the REACH Regulation, as of June 1, 2009. However, these national restrictions will remain in force until June 1, 2013.
This is the subject of this order that we have the honour to submit to your approval.
Please accept, Mr. President, the assurance of our deep respect.
