REACH





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REACH
REACH is a European regulation that came into force on the 1st June 2007, which introduces new rules for managing all chemical substances marketed in the European Union.

The acronym “REACH” resumes the key guidelines of the regulation: Registration, Evaluation, Authorisation and restriction of CHemicals.

The objective of this new policy for managing chemicals is to improve the level of health and environmental protection through improved knowledge of the chemical risks involved.

The REACH Regulation aims to improve knowledge and ensure better risk management of chemicals; importers, producers, distributors and end users of chemicals within Europe all fall within its scope.

In this respect, the different players involved in the graphic chain (manufacturers of inks and varnishes, manufacturers of consumable items, printers, distributors, etc.) are required to take actions to ensure their management systems are brought into line with the regulation.

This article sets out the different steps provided for by the regulation and the requirements that have to be met.

General remarks

The regulation aims to improve knowledge of the intrinsic properties of chemical substances and ensure better management of the risks for humans and for the environment linked to the use of these substances.

The attainment of these objectives hinges on a system that provides for the registration, the evaluation, the authorisation and the restriction of all chemical substances (already existing or newly produced) that are either manufactured in or imported into the European Union.

It is the ECHA (European Chemicals Agency), instituted by the REACH Regulation, which is responsible for administrating the system.

Over time some 30,000 chemicals – as such or contained in preparations or in articles – will have to be registered with the ECHA.

The registration of chemical substances

Since the coming into force of the REACH Regulation, all producers or importers in the European Union of chemical substances (existing or newly produced after the regulation has come into force) involving more than one tonne a year must meet the requirements of the regulation in order to conserve their market authorisation.

Only substances listed on the ELINCS (European LIst of Notified Chemical Substances) (marketed after June 1992 and before the REACH Regulation came into force and which have been registered with the European Union) are excluded from the general framework of this obligation.

The ECHA has made available a dedicated information system to carry out this registration (the REACH-IT information system) and the regulation provides for two distinct steps, depending on the nature of the substances and the strategy adopted by the declarant:

1. Pre-registration, which is optional and restricted to substances known as phase-in substances. These are substances listed in the EINECS (European INventory of Existing Commercial chemical Substances) (substances marketed before September 1981) and those that have been produced but not marketed before June 1992. This pre-registration step, which extends from 1st June to 1st December 2008, will allow declarants who have registered to benefit from a transitory phase for the definitive registration of their phase-in substances. In return for this period of grace, the declarants undertake to share the information that they possess on the intrinsic properties of substances and the risk that they pose to health and the environment on the exchange forums provided for by REACH-IT (known as SFEI), or at least to share the costs inherent in studies to evaluate these properties and assess such risks.

2. Actual registration, obligatory for all substances produced or imported in quantities greater than one tonne a year (with the exception of ELINCS substances), with, for each of the substances concerned, the transmission of a dossier to the ECHA. This dossier must contain information relative to the physical, chemical, toxicological and eco-toxicological properties of the substances.

It must also include a risk management study for each substance, which covers all the conditions of use of the substance in its chain of use. In order to enable such studies, all of the industrial players involved in the supply chain must exchange data relative to all of the various conditions of use of the substance to be assessed, by transmitting information both downstream (from the supplier to the client) and upstream (from the client back to the supplier).

Finally, in the case of substances manufactured or imported in quantities equal to or greater than 100 tonnes per year, the dossier must include proposals for tests (tests on animals) that need to be carried out to improve knowledge of the toxicological risks of the substance in question. This transitional phase will allow declarants who have pre-registered phase-in substances to have a timetable for the definitive registration of these substances. This timetable is established according to the classification of the substance and on the basis of the tonnages of substance produced or imported by the declarant. Phase-in substances must be registered:

• Within 3 1/2 years after the regulation comes into force (in other words on 1st December 2010), for substances in quantities greater than 1000 t/year, CMR(1) 1&2 in quantities greater than 1 t/year and R50-53(2) substances in quantities greater than 100 t/year.

• Within 6 years (i.e. on 1st June 2013), for substances in quantities greater than 100 t/year.

• Within 11 years (i.e. on 1st June 2018), for substances in quantities greater than 1 t/year.

Phase-in substances will only be able to benefit from the transitory registration provisions if they have been preregistered beforehand. If this is not the case, they must be registered immediately (in other words on 1st June 2008) with the AEPC.

Newly produced substances, for their part, must be registered as soon as possible before they are manufactured or released on the market.

Not pre-registering or registering a substance will lead to the suspension of its use and its market authorisation.


Evaluation

Once the substances have been registered, the European Chemicals Agency and competent national authorities will carry out three types of evaluations.

• An evaluation by the ECHA of the compliance of the registration dossier. The aim of this is not to evaluate the quality or the appropriate character of the data itself but instead to ensure the completeness of the data submitted. Once the completeness of the dossier has been checked, the data provided will be made available on the central REACH-IT data base to the competent authorities designated by the Member States (Le Medad in the case of France, with delegation of responsibility to AFSSET and BERPC).

• The examination by the ECHA of the proposals for tests on animals formulated by the declarants for substances manufactured or imported in quantities greater than or equal to 100 tonnes per year and per manufacturer/ importer.

• The in-depth evaluation of substances by the competent authorities on the basis of priority criteria set by the European Union action plan: the first action plan proposal is due to be published before 1st December 2011 at the latest. It will then be drawn up for 3 years and will indicate the substances that need to be examined every year.

Depending on the tonnage produced or imported and the evaluation constraints linked to the tonnage ranges, complementary evaluations may be required for notified substances (i.e. pre-registered substances).

The authorisation of substances

Certain substances of particular concern (CMR 1&2, PBT, vPvB3(3), etc.) will no longer be able to be used unless an authorisation is granted for a specific application. This authorisation may be granted if the applicant is able to demonstrate that the risks associated with the use of the substance are legitimately managed or, if this is not the case, that the social and economic advantages prevail over the risks and that no substitution can be envisaged.
The applicant must, in all cases, provide an analysis of the possible alternative solutions while putting forward information on the research and development work carried out.
In the case where the risk is properly managed, if an appropriate alternative has been identified, a substitution plan proposing a timetable of actions must be provided. Moreover, certain substances are considered as not being able to be authorised on the basis of the demonstration of the managed risk.

Restrictions

A final chapter of the REACH Regulation sets out the restrictions relative to the manufacture, limitation in use and the market release of a certain number of substances, preparations or objects.
To this end, existing European provisions are detailed in Appendix XVII of the regulation. They may be completed by new restrictions at the request of the European Commission or a Member State in particular.

(1). CMR: Carcinogenic, Mutagenic and Toxic for reproduction.
(2). R 50/53 substances: Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.
(3). PBT: Persistent, Bioaccumulative and Toxic. vPvB: Very Persistent and very Bioaccumulative

Did you know?
The project was introduced by the European Commission on 29th October 2003. The final bill went through its second reading by the European Parliament on 13th December 2006 and was passed unanimously on 18th December by the Environment Council.

The transitory provisions: progressive roll-out extending over 11 years
 
REACH-transitory provisions





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