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Reichhold REACH
How does REACH work?

REACH imposes "registration" requirements on each EU manufacturer or importer of chemical substances, whether on their own, in preparations, or released from articles, in quantities of 1 metric ton (1,000 kg) or more per year.
There are some exemptions for specific chemicals (usually low hazard naturally occurring materials).
Polymers meeting the definition under REACH are generally regarded as presenting limited safety risks and are exempt from registration under REACH.
Monomers present at >2% weight by weight in the finished polymer and other substances, however, must be registered if the total quantity of any such monomer or other substance is greater than or equal to 1 metric ton per year.
This provision to register monomers and other substances meeting these conditions applies to importers of polymers into the EU as well as to polymer manufacturers in the EU unless such substances have been registered by an actor up the same supply chain.

Registration involves submitting a technical dossier to ECHA containing information on the identity of the registrant, the substance, its intrinsic hazards, classification and labeling, and guidance on its safe use. For manufacturers or importers with annual substance quantities of 10 metric tons or more, registrants also need to prepare a Chemical Safety Report (CSR), which must include a chemical safety assessment of the environmental and human health hazard properties of the substance. In certain cases, an exposure assessment and risk characterization must also be provided. The CSR is the source from which safe handling information will be extracted and communicated down the supply chain through extended safety data sheets.

Evaluation is comprised of two parts. First, there is a dossier evaluation, which involves a quality check of the dossier, and which may include a check for dossier compliance with REACH requirements. Second, ECHA can undertake a substance evaluation and request further information or testing where there is concern regarding a substance that may pose a significant risk to human health or the environment.

Authorization is a regulatory measure that the authorities may take for Substances of Very High Concern (SVHC), whereby any use of such a substance must be authorized by the European Commission.
The properties of SVHC are defined in Article 57 of the REACH regulation and include:
  • Substances classified as Category 1 or 2 Carcinogens, Mutagens, or toxic to Reproduction (CMR substances)
  • Substances identified as Persistent, Bioaccumulative, and Toxic to the environment (PBT substances)
  • Substances identified as very Persistent and very Bioaccumulative in the environment (vPvB substances)
  • Substances of equivalent concern (i.e., endocrine disrupter, respiratory sensitizer, etc.)
such substances can only be authorized where there are no substitutes and the socio-economic benefits from use outweigh the risk to human health or the environment. The aim is to give industry incentive to progressively replace SVHC with safer alternatives when technically and economically feasible.

Before a material is listed as subject to authorization, it is placed on the ‘candidate’ list of SVHC’s (http://echa.europa.eu/web/guest/candidate-list-table )
Substances on the candidate list are prioritized for authorization and eventual inclusion in Annex XIV of the REACH regulation. Priority for authorization is normally given to substances with PBT or vPvB properties, with wide dispersive uses or those that are manufactured or imported in high quantities.
Placement of an SVHC on the Candidate List triggers immediate communication obligations for manufacturers and importers as well as formulators of preparations and producers of articles where the concentration of the SVHC is above 0.1% (w/w).http://echa.europa.eu/web/guest/candidate-list-obligations

Some materials that have hazardous properties, such as those listed above, may ultimately be managed by other regulatory measures, such as harmonized classification labelling, or restrictions on their use. Details of the various measures that the authorities may use to regulate substance of concern are given on the ECHA website:http://echa.europa.eu/addressing-chemicals-of-concern/substances-of-potential-concern

Restrictions under REACH, may result in any substance on its own, in a preparation, or in an article being subject to EU-wide restrictions if its use poses unacceptable risks to human health or the environment.
Restrictions can be imposed on the use of a substance in certain product types (i.e toys, textiles) or by certain user groups (i.e consumers).

Authorizations and restrictions can also apply to polymers and substances produced or imported in quantities below 1 metric ton per year.

Downstream users of chemicals under REACH also have certain obligations. Downstream users will receive more details SDS’ as chemicals are registered and these may contain detailed exposure scenarios which will specify the appropriate safe handling conditions and uses for which worker and environmental exposure has been deemed acceptable. Downstream users have an obligation to use the materials only within these defined conditions, or to take measures to assess any use not adequately addressed by their suppliers REACH registration/safety assessment. For more information on downstream user obligations, the ECHA website has a section dedicated to downstream users of chemicals:http://echa.europa.eu/en/regulations/reach/downstream-users

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