Recording, evaluation and authorization of the chemicals

The recording, evaluation and authorization of the chemicals - in English: Registration, evaluation and authorization off chemicals ( REACh ) - is payment the European Parliament and the Council of European Union, adopted on December 18th 2006 (n° 1907/2006), which modernizes the EU law as regards Chemical substances, and set up a single integrated system of recording, evaluation and authorization of chemical substances in the European Union.

Its objective is to improve protection of the human Santé and the environment, while maintaining competitiveness and by reinforcing the spirit of Innovation of European chemical industry.

History

The policy of the European Union concerning the substances chemical is based on four principal directives:

the directive 67/548/CEE of June 27th, 1967,
the directive 76/769/CEEdu July 27th, 1976,
the directive 88/379/CEE of June 7th, 1988,
payment (the EEC) n° 793/93 of March 23rd, 1993.

In 1981 a distinction is made between existing chemical substances and chemical substances nouvelles.
The importers and the manufacturers are held to notify the new substances . This one must obey the directive 67/548/CE, which, since an amendment of 1993, requires in more tests and evaluation of the risks for the human health and the environment, when marketing envisages quantities higher or equal to 10 kg/an. Above or in lower part a special regulation is envisaged. Notification and evaluation do not mean however that the new substances are not dangereuses.
In 1993 payment (the EEC) n° 793/93 envisages the evaluation of the 100.000 existing substances , each Member State being distributed the priority substances: that is to say 141 between 1994 and 2004.
The number of existing substances declared in 1981 was of 100.106. In December 2005 it was of 100.204: it is about a closed list. In 2001,2 700 new substances are indexed, approximately 4000 in 2005.

In 1998 the Council of Ministers of the environment of the European Union begins to evaluate the operation of the legal instruments of control of chemical substances in the Community, which lead in February 1999 to a vast meeting in which take part scientific, persons in charge of regulation, industrialists, ONG of protection of nature and defense of the consumers. This book concluded with the need from a reform from the legislation in order to “ensure an elevated level of protection of the human health and environment”, while making it possible “to guarantee the good performance of the interior market and to take care of the competitiveness of the chemical industry” of the European Union. It considers the creation of a new control system of the chemical substances whose main aim is “to guarantee information adequate and accessible to all, as well as a suitable management of the risks arising out of the existing substances and the new substances”. This system, called REACH, functions on the basis of authority of recording, another of evaluation and a last of authorization of the substances. One of the main issue raised by the study was which the substances existentes were not subjected to the same requirements of test as the news, leading to a general ignorance of the properties and uses of these first. Moreover in fact the authorities were in charge of the evaluation instead of the companies which produced, imported or used the substances. legislation required only information on behalf of the manufacturers and of the importers of substances, and not of the users located downstream (industrial users and formulateurs). Finally this ignorance was also regarded as a barrier with research and the industrial innovation, insofar as the industrialists prefer to use the substances " existantes" because less expensive, instituting a European Agency of the chemicals and modifying the Directive 1999/45/CE and regulation (EC) on the persistent organic pollutants. The European commission adopts the draft Regulation REACH.

The proposal for a Regulation was voted on November 17th, 2005 by the European Parliament and was adopted in second reading on December 13rd, 2006. The payment comes into force gradually as from 2007. In France, it applies starting from June 1st, 2007.

After intense negotiations between the Commission, the Parliament, the Member States of the European Union and the parts interested, the last points making debate related to a possible simplification of the declaration of the substances of low volume, and the methods of authorization of the alarming substances (Cancérigène S, Mutagène S, Repro-poison S, etc).

Political tendencies

new the payment aims to the progressive abolition in the European Union of the most dangerous chemical substances. With this intention, the burden of proof of the harmlessness of the chemicals usually used is reversed: it will be up to the industrialist to show that the substance used is without danger to the man and nature. It should oblige the producers and importers to make studies on the Risque S on the human health and the Environnement of the chemical molecules before their marketing or their use.

REACH envisaged a regulation of all chemical substances, produced or imported, existing or new, starting from an annual volume higher than a ton, that is to say: 30000 substances (among more: 100000 used in Europe).

the European Union envisages the creation of a European Agence of the chemicals. This one will record the molecules, will make them evaluate and will record them in a database accessible to the companies, the private individuals and the ONG.

Certaines substances is subjected to a specific authorization:

- those classified CMR 1 or 2 (carcinogen, mutagen, repro-poison)

- those most harmful for the environment, i.e.:

°Persistant, Bioaccumulable, Poison for the environment (" PBT")

°ou very Persistent, very Bioaccumulable (" vPvB")

- and those which the Agency estimates to present a very high risk (the Agency holds the right to define itself which substances must be subjected to authorization).

These substances subjected to authorization are considered alarming and must be regularized within 3 year 1/2 starting from June 1st, 2007 (the list of these substances will be put in appendix XIV of the payment within one year).

Exemptions

REACH is not applicable:

with the radioactive substances (directive 96/29 Euratom)
with the substances subjected to a customs control, in temporary deposit, free zone or frank warehouse for their re-exportation, or in transit
with the transport of dangerous substances such as they are or contained in dangerous preparations (all modes)

Exemptions specific to the various processes (recording, evaluation, authorization and restrictions)

waste (to dir. 75/442 and modifications) are not regarded as substances, preparations or articles within the meaning of art 3 (definitions) REACh

possible Exemptions by the Member States so necessary to the interests of defense

Various statutes

The payment defines 3 statutes different with respect to the obligations towards the European Agence from the chemicals.

The importer

The user downstream

The manufacturer

Implementation

Expiries

The payment envisages expiries while functioning of definite bands of tonnage. The more important the production is, the more the regulatory requirements are it too.

t/a = ton per annum

From January 2009 will be held of the Forums of Exchange of information on the Substances. These forums have as a role to bring together all the manufacturers and importers (obligatory) as well as the users downstream (optional) concerned with same and single substance. They will be able to thus exchange information which they already have in their possession and will have to choose a responsible company to make the tests necessary to supplement the files.

The registration file

It is composed of 3 parts.

the Card of data of safety (FDS),
the technical dossier,
for certain substances, of a Report/ratio on Chemical Safety (RSC).

The technical dossier

It must comprise following information:

Identity of the importing manufacturer/=> informant
Identity of the Substance
Information on manufacture, uses the identified (y.c disadvised uses); in option: categories of use and exposure
Classification/labelling
Conseils of use
Résumés study (Appendices VII-X)
Résumés studies consistent (Additional VII-X if the appendix I prescribes it)
Certaines information examined by an appraiser chosen by the F/I (suitable experiment)
Proposition (S) of tests if those are enumerated in appendices IX-X (S > 100 t/an)
For the S < 10 t/an: information concerning the exposure (appendix VI section 6)
Request for protection of certain data (art 118) with respect to the publication on Internet (+ justification)

The Report/ratio on Chemical Safety

It relates to the substances produced with more than 10 tons per annum. It is an evaluation of the Chemical Safety which measures:

dangers to the human health
physicochemical dangers with respect to the human health
dangers to the environment
evaluation PBT and vPvB

and for the substances answering the criteria of classification CMR 1&2 category and PBT/vPvB, it is also made up of:

Evaluation of the exposure (Scenario of Exposure)
Characterization of the risk for the whole of the identified uses

Weak points of the payment

REACh is however marked to cause a significant growth of the number of tests on the animals. Currently, one can consider that in the absence of checks, it is the totality of the European population and the environment, and this, since several decades, which “tries out” all the substances: including riskiest.

In addition, in June 2006, of the States like the the United States, the India or the Brésil estimated that this text could constitute an obstacle with the international business: the Multinationale S of chemistry, broken with the Lobbying at these States largely promoted this argument.

the ultimate controversy related to the authorization of the substances for which the dangers are proven: carcinogens, mutagen and poisons for the reproduction. The ecologists asked for immediate prohibition of it. The industrialists obtained the right to continue to use them if they show that they cannot replace them and that they study the design of substitutes.

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