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Quality management  |  Reach  |  Environment

What is REACH?

REACH is a new European Community Regulation on chemicals and their safe use (EC 1907/2006). It deals with the Registration, Evaluation, Authorisation and Restriction of Chemical substances. The new law entered into force on 1 June 2007.

The aim of REACH is to improve the protection of human health and the environment through the better and earlier identification of the intrinsic properties of chemical substances. At the same time, innovative capability and competitiveness of the EU chemicals industry should be enhanced. The benefits of the REACH system will come gradually, as more and more substances are phased into REACH. The REACH Regulation gives greater responsibility to industry to manage the risks from chemicals and to provide safety information on the substances.

REACH Pre-Registration

Regulation (EC) No 1907/2006 (REACH), requires that chemical substances on their own, in preparations and those which are intentionally released from articles to be (pre) registered.

In order to be able to maintain manufacture, import and marketing of a phase-in substance during the transitional period, pre-registration is a one time process that has to take place in the period from 1 June 2008 to 1 December 2008. Kapachim has pre-registered all its products to take advantage of the transitional registration deadlines and has initiated the data sharing process with other manufacturers and importers. You can get in touch with us should you need the pre-registration number and submission report for a certain material within our product range.

REACH Registration

Producers or importers of articles will need to register or notify those substances in their articles which meet the criteria for classification as dangerous, are present in a quantity of more than 1 tonne per producer or importer per year per article type and are either intentionally or unintentionally released.

A producer of articles does not have an obligation to register or notify a dangerous substance, if a supplier further up the supply chain, has already registered the substance for that use (Art. 7(6)). Only registered substances are allowed to be manufactured or imported.

Each manufacturer or importer of a substance shall submit his registration dossier for the substance to the Agency, accompanied by a fee.

The registration dossiers submitted to the Agency will be handled electronically to facilitate the management of the expected amount of registrations that will be submitted. The Agency assigns a registration number and a registration date to each registration dossier received and immediately communicates this information to the registrant.

Within 3 weeks of the registration date, the Agency performs an automated completeness check of the dossier to ascertain that all elements required for the registration are included. If the registration is incomplete, the Agency will inform the registrant within these 3 weeks from the registration date about which further information is needed and will set a deadline for completion of the dossier.

The registrant needs to submit the requested missing information in an updated dossier to the Agency within the set deadline. The Agency then confirms the submission date of this information and makes a further completeness check within 3 weeks of receipt of the updated dossier.

If the registrant fails to complete his registration within the set deadline, the registration will be rejected by the Agency and the manufacturer or importer is not allowed to start or continue manufacture or import of the substance.

The Agency will forward the registration dossier, the registration number and date, and the result of the completeness check to the authorities of the Member States in which the manufacturers and importers are established to enable enforcement action, if necessary. Also the further information that is submitted for completion of the dossier will be forwarded to the competent authority together with the result of the second completeness check.

REACH Evaluation

Process The evaluation process has three purposes:

  • The first purpose is for authorities to evaluate the testing proposals made by industry to ensure the safety of their products and thereby ensuring that animal testing is kept to a minimum.
  • The second purpose is to check compliance with the requirements of the regulation.
  • The third purpose is to examine any suspicion of risks to human health and the environment arising from substances. Evaluation provides a means for the authorities to require registrants, and in very limited cases downstream users, to provide further information.

There are two types of evaluation: dossier evaluation and substance evaluation:

  • Dossier evaluation is conducted by authorities to examine proposals for testing to ensure that unnecessary animal tests and costs are avoided, and to check the compliance of registration dossier with the registration requirements.
  • Substance evaluation is performed by authorities when there is a reason to suspect that a substance presents a risk to human health or the environment (e.g. because of its structural similarity to another substance). Therefore, all registration dossiers submitted for a substance are examined together and any other available information is taken into account.

REACH Authorisation

The REACH proposal sets up a system under which the use of substances with properties of very high concern and their placing on the market can be made subject to an authorisation requirement.

This authorisation requirement ensures that risks from the use of such substances are either adequately controlled or justified by socio-economic grounds, having taken into account the available information on alternative substances or processes.

The substances selected for the authorisation system have hazardous properties of such very high concern that the Community needs to decide about the adequacy of the control of risks arising from their uses or about the socio-economic benefits of the uses of such substances that justify risks arising from their use:

Category 1 and 2 CMR substances have effects on humans which are generally so serious and cannot normally be reversed, and PBT and vPvB substances accumulate in living organisms, which cannot normally be reversed, either. To provide a security net, other substances with serious and irreversible effects of an equivalent level of concern as the CMR, PBT and vPvB substances, can be identified on a case-by-case basis. This could for example be endocrine disrupters which are not already covered by the CMR criteria.

The authorisation provisions require those using or making available substances with properties of very high concern which are included into the system to apply for an authorisation for each use, regardless of the quantity of the substance used, within deadlines set by the Commission.

The burden of proof is placed on the applicant to demonstrate that the risk from the use is adequately controlled or that the socio-economic benefits outweigh the risks. In the latter case, applicants need to submit a substitution plan along with a socio-economic analysis.

The Agency, via its Committees for Risk Assessment and Socio-economic Analysis provides opinions on the applications, which the Commission will use for its decisions on applications.

Data Sharing & Substance Information Exchange Forum (SIEF)

One of the objectives of REACH is to limit vertebrate animal testing as far as possible, while balancing that with the generation of necessary information to identify the hazard of substances. Therefore duplicate animal testing has to be avoided and tests on vertebrate animals for the purposes of REACH shall only be undertaken as a last resort. Before new tests are conducted to comply with the identified information needs (Annex XI), and thus with the information requirements, potential registrants have to take part in the data sharing mechanisms set up for tests on vertebrate animals. They may use those mechanisms for other tests not involving vertebrate animals to save time and money.

As a first step, summaries and robust study summaries of tests will only be protected for ten years from their Registration, after this time period the Agency will make them freely available to all potential registrants asking for them.For other tests, the mechanisms set up shall encourage manufacturers and importers of substances to come to an agreement on the sharing of tests and costs. Forced sharing of tests involving vertebrate animals is a last resort. Before testing on vertebrate animals is carried out, the potential registrant will need to check whether the same substance has already been registered, or whether another potential registrant is making an inquiry to register the same substance at the same time. This is done by looking in the Agency's database, and by submitting information to the Agency about himself, his substance and which information requirements would require new studies on vertebrate animals and other new studies to be carried out by him. 

Downstream User Obligations 

Downstream users will need to apply appropriate measures to adequately control the risks arising from their use of substances meeting the criteria for classification as dangerous.

A downstream user is any natural or legal person established within the Community, other than the manufacturer or the importer, who uses a substance, either on its own or in a preparation, in the course of his industrial or professional activities.

Use means any processing, formulation, consumption, storage, keeping, treatment, filling into containers, transfer from one container to another, mixing, production of an article or any other utilisation.

REACH requires downstream users to identify and apply appropriate measures to adequately control the risk identified in any safety data sheet supplied to them. In addition to REACH, other law on chemicals, such as Directive 98/24/EC on chemical agents requires assessment and control of substances. If the substance was registered in their supply chain by a manufacturer or importer in quantities of 10 tonnes or more per year then their use of the substance will need to have been assessed in a CSA to ensure it can be adequately controlled.

Two possibilities are foreseen in REACH for the generation of a CSA, to give downstream users a choice:

  1. Downstream users will have to develop their own appropriate risk management measures in a chemical safety assessment in accordance with Annex I, if they use a substance outside the conditions described in an exposure scenario communicated to them in a safety data sheet annex. This will particularly be the case if the downstream users want to use a substance for uses which are not foreseen or not even thought of by their suppliers, and the downstream users prefer to keep these uses confidential. In this case they will have to report certain information to the Agency. However, there is no obligation for the downstream users to perform a CSA, if they do not receive a safety data sheet with exposure scenarios in the Annex, for one of the following reasons: . the manufacturer or importer who supplies them with the substance registered less than 10 tonnes per year, and therefore did not need to perform a CSA, or the substance is not dangerous so that there is no obligation to compile a SDS.
  2. Downstream users do not need to perform their own chemical safety assessments, if they use substances within the conditions described in exposure scenarios communicated to them in a safety data sheet. In this case, they will have to apply the risk management measures communicated to them and therefore, they need to make sure that the safety data sheets in fact contain information that is appropriate to adequately control the risks arising from their uses. If he does not agree that the identified risk management measures are appropriate, he will need to inform his supplier and wil have to resolve the matter with him or carry out a chemical safety assessment himself.

Classification & Labelling

For the time being, all suppliers of substances are obliged to classify and label them in accordance with Council Directive 67/548/EEC (Annex I to Directive 67/548/EEC) before they place them on the market.

This obligation is independent of the quantity manufactured or imported. This classification needs to be done on the basis of their investigations about accessible and relevant data on the properties of their substance(s).

The data on the intrinsic properties of the substance have to be compared with the criteria for classification and labelling as established in Directive 67/548/EEC and the appropriate classification and labelling shall be derived.

 
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