The authorization procedures apply to substances with certain intrinsic properties, i.e., to (a) substances meeting the criteria for classification as carcinogenic, mutagenic, or toxic for reproduction category 1 or 2 according to Directive 67/548/EEC, (b) substances which are persistent, bioaccumulative and toxic or those "giving rise to an equivalent level of concern," (c) substances which are very persistent and very bioaccumulative or those "giving rise to an equivalent level of concern," and (d) other substances giving rise to an "equivalent level of concern", such as those having endocrine disrupting properties, which are identified on a case-by-case basis.
These substances, which will be included in Annex XIII to the Regulation by the European Commission on the basis of a "priority" recommendation from the Agency, can only be used by those who obtain an authorization and by their customers for the particular uses authorized. This limitation shall not apply to the use of substances in preparations below the concentration limits specified in Directive 1999/45/EC, which result in the classification of the preparation as dangerous.
Authorization are to be granted if the risk is adequately controlled, or if socio-economic benefits outweigh the risk to human health and/or the environment arising from the use of the substance. Importantly, notwithstanding the authorization conditions, the holder shall ensure that the level of exposure is reduced "as low as is technically possible."
Applications for authorization may be submitted collectively by manufacturers, importers, and/or downstream users. Downstream users may only use a substance supplied by the holder of the authorization, and only within the conditions of the authorization. They must notify the European Chemicals Agency within three months of the first supply of the substance
Issues of concern
Substances "meeting the criteria" for classification as CMRs Category 1 or 2 will be subject to the authorization procedure. It is not clear on what basis, or by whom, a decision will be made that a substance "meets the criteria for classification" as a CMR category 1 or 2, as opposed to a substance "classified" as CMRs category 1 or 2 in Annex I to Directive 67/548/EEC.
It is not clear which authorizations will be granted at Community level, and which at Member State level. According to previous correspondence from the European Commission, substances which are placed on the market in more than one Member State will be subject to Community authorization, while substances which are only manufactured and/or placed on the market in one Member State will be subject to national authorizations. The question remains whether the decision of a Member State to deny authorization can be challenged at Community level, or whether a Community authorization can be obtained subsequently if the national one is not granted.
The procedure for the identification of a substance "of equivalent concern", which precedes the Agency's recommendation for inclusion in Annex XIII, can be initiated solely by a Member State. This would allow any Member State to effectively require that the Commission at least consider prohibiting the manufacture, import, sale or use of certain substances that are currently considered "undesirable" by the Member State.
There are no provisions laying down clear criteria or deadlines for the identification of substances that will be included in Annex XIII. There are equally no provisions ensuring participation of industry in the identification procedures, or ensuring application of the "right to be heard".
Importantly, in addition to compliance with the conditions of the authorization, "the [authorization] holder shall ensure that the level of exposure is reduced to as low as is technically possible". This provision will potentially have a great impact; if exposure reduction requirements must be achieved by application of "state of the art" technology, that would appear, as a practical matter, to eliminate any consideration of economic or social benefit factors.
(The provisions related to authorization are included in Points 44 to 55 of the Regulation.)
Last Updated: May 2003