Regulation (EC) n° 1907/2006 of the European Parliament and of the Council, called the “REACH” regulation (from the acronym “Registration, Evaluation, Authorization of Chemicals”) and concerning the registration, evaluation, authorization and restriction of chemicals, provides for the registration of all substances produced or imported into the European Union in quantities greater than one ton per year.
The REACH applies to all substances as such or as part of a preparation or article, manufactured, imported or used in the European Community.
The art. 5 is the backbone of the entire Regulation, namely: NO DATA, NO MARKET.
No substance can be manufactured or placed on the European market in quantities exceeding one tonne/year unless it has been registered.
The registration of a substance consists in the submission, by the manufacturers or importers, of some basic information on its characteristics; The information to be reported for general registration purposes is proportional to the tonnage band and includes:
- the technical file
- the chemical safety report (for substances produced or imported above 10 tons/year
To facilitate the preparation of the dossiers, the possibility of setting up CONSORTIES, ie groups of registrants, is envisaged, in order to favor the exchange of available data and the common commissioning of tests for missing data, thus reducing the relative individual costs.
EXCLUSIVE REPRESENTATIVE – Only Representative
Companies based outside the European Union are not allowed to submit REACH registration dossiers for chemicals to ECHA, however in accordance with Article 8 they can appoint an Exclusive Representative established in Europe to take over the tasks and the responsibilities of importers in order to ensure compliance with the Regulation.
The qualitative evaluation process of the registration dossiers is carried out by ECHA and is implemented on two levels:
- Quality control and compliance with the requirements of the various relevant titles and annexes (approximately 5-10% of the total number of files submitted);
- Examination of each experiment proposal intended to produce the data required for the higher tonnage bands (between 100 and 1000 tons/year).
The evaluation of substances, on the other hand, is carried out by the competent authorities of the Member States. In fact, ECHA periodically draws up a progressive action plan at Community level with the substances to be evaluated on the basis of priorities according to the possibility of a risk to human health or the environment and also on the basis of the overall tonnage resulting from the registration of several registrants.
The authorization process starts when a Member State or ECHA, at the request of the Commission, proposes a substance to be identified as an SVHC if the following hazardous properties are recognized:
- substances that meet the criteria for classification as carcinogenic, mutagenic or toxic for reproduction (CMR) of category 1A or 1B;
- substances that are persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumalable (vPvB);
- endocrine disruptors.
The intention to propose a substance as an SVHC is published in the register of intentions prior to the submission of the proposal, to inform interested parties in advance.
After the publication of the proposal, interested parties can submit comments or provide additional information during the 45-day consultation, and comments can be made on the properties of the substance, its uses and alternatives.
- In the absence of any comments that could question the identification, the substance is placed directly on the Candidate List.
- If, on the other hand, comments are received that provide new information or question the identification of a substance as an SVHC, both the proposal and the comments are sent to the Member State Committee for agreement.
INCLUSION IN THE LIST OF CANDIDATE SUBSTANCES
Inclusion in the Candidate List implies immediate obligations for their suppliers, such as:
- provide a safety data sheet (SDS);
- communicate instructions on safe use;
- respond to consumer requests within 45 days;
- inform ECHA if the article they produce contains an SVHC in a concentration greater than 0.1% by weight and if the quantity of this substance is greater than one tonne per producer/importer per year.
APPLICATION FOR AUTHORIZATION
Authorizations are tied to whoever requests them and can only be valid along a single supply chain. A substance included in Annex XIV may be used and/or marketed if:
- the immediate downstream user has requested authorization for such use, or
- the downstream user can use the substance if the use has been authorized to an actor up the supply chain.
Restriction is a measure intended to protect human health and the environment from the risks posed by chemicals, usually designed to limit or prohibit the production, placing on the market or use of a substance, and may include specific conditions what technical measures and labeling obligations.
A restriction can be applied to any substance, on its own or as a component of a mixture or article, it can also be a substance subject to registration under the REACH.
As for authorizations, the restrictions are also independent of the annual tonne threshold; furthermore, all the substances included in Annex XIV (authorization) for which no company has requested a specific authorization will be transposed into Annex XVII and deleted from the previous one with a restriction on all uses.
ANALYTICAL IDENTIFICATION OF SUBSTANCES
GAP DATA ANALYSIS
CSA AND CSR
NOTIFICATION OF C&L
ASSUMPTION OF THE OFFICE OF OR (Sole Representative)
SIEF AND CONSORTIUM MANAGEMENT
Danger and Safety offers a consultancy service to support your company in the correct management of obligations and in the search for the best solutions to correct any regulatory non-compliance, in order to avoid running into heavy administrative penalties or even seeing the marketing of its products blocked.
Danger and Safety is present in several Consortia representing many companies. The service is implemented in the most complete respect for confidentiality and confidentiality, constituting an enormous relief from commitments for companies.
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