System of regulation – legislation REACH

Development of the new chemical legislation in EU is completed.

On December, 13, 2006 in Brussels (Belgium) at 12 o'clock 31 minute on local time at 529 voices “pro”, 98 “contra” and 24 "HAVE REFRAINED" the European Parliament has accepted the new chemical legislation - REACH regulation (Registration, Evaluation and Authorisation of Chemicals). On December, 18 REACH it has been signed by the President of the European Union and the President of the European Parliament.

REACH (registration, test, examination, restriction of release) will reserve ways of the control over chemicals: since June, 1, 2007 within 11 years it will be tested about 30 thousand chemical substances with the purpose to define, whether they represent danger to a human body and an environment.

The purposes of new European legislation REACH:

  • Aspiration to avoid chemical environmental contamination, keeping biological variability;
  • A labour safety of workers, safety of a life of citizens;
  • Aspiration to balance of health and ecology with the competitive, innovative industry of Europe.

According to new system of regulation in the regions of the conversions of chemical production, all enterprises of the European Community making or importing over one ton of chemical substances in year, will be obliged them to register in central depositary.

REACH will replace more than 40 documents of the current legislation of Europe. Among the basic changes - displacement of burden of work under the proof of safety of chemical substances from the state bodies on the company which are engaged in manufacture, import and use of such substances.

From here the question logically follows - how to prevent unfair granting the information on substances, and also the enterprises and importers? In REACH is solved to bring in additional measures of regulation: carrying out of an independent expert appraisal which will check some substances (all about 20 substances in one year) on the choice.

According to statistics, now only 10 % of issued chemical substances are exposed to careful check. It causes special concern in use of such dangerous substances as carcinogens, proof organic pollutant, mutagen substances and other. For them in the new legislation the compulsory procedure of reception of sanctions is stipulated. To receive such sanction, the applicant should prove, that use of the given dangerous substance is adequately supervised and that social and economic benefits of its application exceed the risk connected to it. All such substances should be registered by 2018.

It is necessary to pay attention that the Commission on development REACH has ratified the project of not equivalent registration of registration of chemical substances. It means, that the level of rigidity of requirements to registration of registration will depend not only on a level of danger, but also from quantity of imported substance. So the softest requirements are showed to import of 1-10 tons of substance, then 10-100, 100-1000 and the most strict conditions for the elements imported in quantity of 1000 and more tons (less than tons at all are not subject to registration).

To the legislation 4 political parties (EPP-ED, PES, ALDE, UEN), CEFIC (the European Chemical Industry Council) and other public organizations were engaged in development and entering of amendments nine Commissions of the European Parliament, Council of Ministers, the Commission on development REACH.

Principal cause of creation of the new legislation - use of chemical substances, at manufacturing any production leaving on the market therefore the new bill mentions not only chemical branch, but also all European industry.

Since April, 2007 European chemical agency (ЕCА) which will operate the basic register starts to operate and to be responsible for process of registration and the sanction. The agency will locate in Helsinki (Finland).

There are some questions concerning coordination REACH with national legislations of the countries of Europe, the external countries, the international organizations. On hearings, the special instruction regulating the given procedures will be prepared.

Who will be the European chemical agency: the Ministry of the chemical industry of Europe or the Agency supervising and regulating observance REACH? The cabinet is declined on the party of creation of strong, imperious structure. However here again there is a complexity - than the Agency becomes larger, especially ramified there is its bureaucratic structure (it is planned more than 400 employees) which can considerably complicate the prompt realization of the program, plus it will be automatically necessary to increase resources by its contents and functioning. As a whole, direct and indirect charges which will be incurred with the industry and a society with introduction REACH, can make 13-30 billion euro, and benefit in the regions of a labour safety for 30 years is estimated at present in 17-54 billion euro.

The president of European Parliament Josep Borrell has commented on acceptance of law REACH: «It is one of the most difficult texts in a history of EU. He establishes legislative balance in public health services and protection of an environment against risks of application of chemical substances, not threatening the European competitiveness. He offers citizens of EU full protection against set of toxic substances in an everyday life in territory of Europe».

The basic amendments accepted in the second reading by the European Parliament:

  • The sanction of dangerous substances. For manufacturers of dangerous substances, the obligation, about replacement by more safe alternative substance is entered. If the alternative does not exist, manufacturers should present scientifically research plan on detection of such alternative (the period of 6 years of researches), further the analysis in light of socially economic expenses and benefits;
  • Registration of substances. For substances, with manufacture less than 10 tons one year are given the period of 12 years for the recommendation of inclusion of substances in regulation and the period of 7 years for malignant and mutagen substances. Are strengthened requirements to registration of the intellectual property on chemical substances;
  • Requirements to care. It is provided, that manufacture, import, accommodation in the market of substances should guarantee reasonably foreseeable circumstances which are not harming human health and an environment. It means gathering the necessary information on considered substances and transfer of recommendations on their use on all circuit of manufacture;
  • A minimum quantity of tests for animals during registration of chemical substances;
  • An estimation of substances. The parliament appoints 2 heads of the European chemical agency, after their representation to Committee on ecology at the European Commission;
  • Information communication. Granting of the public of the information on the dangerous substances contained in products, by quantity of 0.1 % from full weight of a product, by inquiry of the interested person. Creation at the international level of the European quality symbol for chemical products is recommended.

The following stage after the second reading should become the statement in Council of Ministers where the modified amendments to the law have been approved. Further regulating and normative documents, so-called (REACH Implementation Projects) RIP where technical managements and tools for the industry and authorities will enter, a regulation of work of Agency, preparatory actions of the Commission for REACH are developed.

The management for the industry (RIP-3) includes:

  • Preparation of the file for registration;
  • A management on check of identity of substances;
  • A management on data exchange;
  • A management under applications for the sanction;
  • A management on SEA;
  • The management agrees the System of classification and marks of chemical substances (SGS);
  • The requirement for products;
  • A management for the further users;
  • Requirements to the information;

Therefore legislation REACH inures equally in 6 months after acceptance. During same time, that is in April - June, 2007, begins the work and the European chemical Agency.

In spite of the fact that legislation REACH is planned to enter only in territory of Europe, very sharply there is a question on conformity of the Russian chemical industry to the international standards and on competitiveness of domestic chemical production. If the enterprises will refuse or cannot observe norm and rule REACH on all cycle of an industrial chain access for the Russian export on the markets of the countries of the European Community will be closed.

The Russian Chemists Union with the help of the foreign partners for a long time traces and informs members of the Union on occurring changes in the European legislation and today when process of formation of the law is completed, and began a stage normative-practical registration of innovations, it is necessary to begin serious work on preparation of the Russian industry for functioning in new realities of the European market. At what it concerns not only the chemical industry, but also metallurgy, motor industry, packing, manufacture of inorganic substances, a building industry, paper, manufactures of cellulose, electronics.

In this connection the Russian Chemists Union together with OOO « Delovaya Russia» with participation of Russian Industry and Enterprise Union came to a conclusion about necessity to start all-round preparation business of community to acceptance of the new European legislation and have decided to organize a permanent working commission of experts for carrying out of a series of actions under the common theme: « About development of a position Russian business of community, in connection with acceptance by the European Union of the legislation "REACH". Questions and problems of harmonization of the Russian legislation with the European legislation and the system of classification and marks of chemical substances (SGS) ».

During work of joint working group the complex of actions in which have come the organization of the congress, carrying out of some thematic seminars has been determined.

For this work is solved to generate Organizing committee in which representatives of OOO « Delovaya Russia » have come, the Russian Industry and Enterprise Union, the Russian Chemists Union, large corporations, the Ministry of Foreign Affairs of the Russian Federation, the Ministry of Industry and Energy of the Russian Federation, Ministry for Economic and Trade the Russian Federation, Federal agency on technical regulation and metrology and it is constant operating working group of experts of the industry, representatives of associations, the ministries and departments.

By results of organizational session of working group the Decision and the Plan of work of permanent working group have been produced.

The basic aspects of the decision:

  1. To inform participants business of community with participation of the international experts on the new European legislation in the regions of a revolution of chemical substances "REACH";
  2. To create preconditions for study of positions and instructions of the law;
  3. To develop problem areas and to assist business to community;
  4. To pay attention the state structures to gravity of arising preconditions on closing export of the industrial goods on the markets of Europe, and a presence of ways of their decision;
  5. And others.