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... 8. Special account should be taken of the potential impact of this Regulation on small- and medium-sized enterprises (SMEs) and the need to avoid any discrimination against them. ...

... 34. Requirements for generation of information on substances should be tiered according to the volumes of manufacture or importation of a substance, because these provide an indication of the potential for exposure of man and the environment to the substances, and should be described in detail. To reduce the possible impact on low volume substances, new toxicological and ecotoxicological information should only be required for priority substances between 1 and 10 tonnes. For other substances in that quantity range there should be incentives to encourage manufacturers and importers to provide this information. ...

... 93. In order to finalise the procedure in due time, the Agency should submit its opinions on the suggested action and its impact on the basis of a draft opinion prepared by a rapporteur. ...

... (a) the circumstances of the original authorisation have changed so as to affect the risk to human health or the environment, or the socio-economic impact; or ...

... 1. When there is an unacceptable risk to human health or the environment, arising from the manufacture, use or placing on the market of substances, which needs to be addressed on a Community-wide basis, Annex XVII shall be amended in accordance with the procedure referred to in Article 133(4) by adopting new restrictions, or amending current restrictions in Annex XVII, for the manufacture, use or placing on the market of substances on their own, in preparations or in articles, pursuant to the procedure set out in Articles 69 to 73. Any such decision shall take into account the socio-economic impact of the restriction, including the availability of alternatives. The first subparagraph shall not apply to the use of a substance as an on-site isolated intermediate. ...

... 1. Within 12 months of the date of publication referred to in Article 69(6), the Committee for Socio-economic Analysis shall formulate an opinion on the suggested restrictions, based on its consideration of the relevant parts of the dossier and the socio-economic impact. It shall prepare a draft opinion on the suggested restrictions and on the related socio-economic impact, taking account of the analyses or information according to point (b) of Article 69(6), if there are any. The Agency shall publish the draft opinion on its website without delay. The Agency shall invite interested parties to give their comments on the draft opinion no later than 60 days from the publication of that draft opinion. ...

... 1. Within 12 months of the date of publication referred to in Article 69(6), the Committee for Socio-economic Analysis shall formulate an opinion on the suggested restrictions, based on its consideration of the relevant parts of the dossier and the socio-economic impact. It shall prepare a draft opinion on the suggested restrictions and on the related socio-economic impact, taking account of the analyses or information according to point (b) of Article 69(6), if there are any. The Agency shall publish the draft opinion on its website without delay. The Agency shall invite interested parties to give their comments on the draft opinion no later than 60 days from the publication of that draft opinion. ...

... (d) a Committee for Socio-economic Analysis, which shall be responsible for preparing the opinion of the Agency on applications for authorisation, proposals for restrictions, and any other questions that arise from the operation of this Regulation relating to the socio-economic impact of possible legislative action on substances; ...