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: REACH - Registration, Evaluation, Authorisation and Restriction of Chemicals [go to this PREAMBLE]
... (69) To ensure a sufficiently high level of protection for human health, including having regard to relevant human population
groups and possibly to certain vulnerable sub-populations, and the environment, substances
of very high concern should, in accordance with the precautionary principle, be subject to careful attention. Authorisation
should be granted where natural or legal persons applying for an authorisation
demonstrate to the granting authority that the risks to human health and the environment arising from the use of the substance
are adequately controlled. Otherwise, uses may still be authorised if it can be shown that the socio-economic
benefits from the use of the substance outweigh the risks connected with its use and there are no suitable alternative substances
or technologies that are economically and technically viable. Taking into account the good functioning of the internal market
it is appropriate that the Commission should be the granting authority. ...
... (72) To support the aim of eventual replacement of substances
of very high concern by suitable alternative substances
or technologies, all applicants for authorisation
should provide an analysis of alternatives considering their risks and the technical and economic feasibility of substitution,
including information on any research and development
the applicant is undertaking or intends to undertake. Furthermore, authorisations should be subject to time-limited review
whose periods would be determined on a case-by-case basis and normally be subject to conditions, including monitoring. ...
... (73) Substitution of a substance on its own, in a preparation or in an article should be required when manufacture, use
or placing on the market of that substance causes an unacceptable risk to human health or to the environment, taking into
account the availability of suitable safer alternative substances
and technologies, and the socio-economic
benefits from the uses of the substance posing an unacceptable risk. ...
... (74) Substitution of a substance of very high concern by suitable safer alternative substances
or technologies should be considered by all those applying for authorisations of uses of such substances
on their own, in preparations or for incorporation of substances
into articles by making an analysis of alternatives, the risks involved in using any alternative and the technical and economic
feasibility of substitution. ...
: Aim of authorisation and considerations for substitution [go to this ARTICLE]
... The aim of this Title is to ensure the good functioning of the internal market while assuring that the risks from substances
of very high concern are properly controlled and that these substances
are progressively replaced by suitable alternative substances
or technologies where these are economically and technically viable. To this end all manufacturers
and downstream users
applying for authorisations shall analyse the availability of alternatives and consider their risks, and the technical and
economic feasibility of substitution. ...
: Granting of authorisations [go to this ARTICLE]
... 4. If an authorisation
cannot be granted under paragraph 2 or for substances
listed in paragraph 3, an authorisation
may only be granted if it is shown that socio-economic
benefits outweigh the risk to human health or the environment arising from the use of the substance and if there are no suitable
or technologies. This decision shall be taken after consideration of all of the following elements and taking into account
the opinions of the Committee for Risk Assessment and the Committee for Socio-economic
Analysis referred to in Article 64
(4)(a) and (b): ...
... (d) available information on the risks to human health or the environment of any alternative substances or technologies. ...
... 5. When assessing whether suitable alternative substances or technologies are available, all relevant aspects shall be taken into account by the Commission, including: ...
: Procedure for authorisation decisions [go to this ARTICLE]
... 2. The Agency
shall make available on its web-site broad information on uses, taking into account Articles 118
on access to information, for which applications have been received and for reviews of authorisations, with a deadline by
which information on alternative substances
or technologies may be submitted by interested third parties. ...
... 3. In preparing its opinion, each Committee referred to in paragraph 1 shall first check that the application includes
all the information specified in Article 62
that is relevant to its remit. If necessary, the Committees shall, in consultation with each other, make a joint request
to the applicant for additional information to bring the application into conformity with the requirements of Article 62
. The Committee for Socio-economic
Analysis may, if it deems it necessary, require the applicant or request third parties to submit, within a specified time
period, additional information on possible alternative substances
or technologies. Each Committee shall also take into account any information submitted by third parties. ...
... Information on exposures, alternative substances and risks ...
... The available use and exposure information and information on alternative substances and techniques shall be provided. ...
... Available information on alternative substances and techniques shall be provided, including: ...
... - availability, suitability, and technical feasibility of alternative substances
and/or technologies, and economic consequences thereof, and information on the rates of, and potential for, technological
change in the sector(s) concerned. In the case of an application for authorisation
, the social and/or economic impacts of using any available alternatives, ...