Considerations on COM(2022)461 - Amending numerous regulations on emergency procedures for the conformity assessment, adoption of common specifications and market surveillance due to a Single Market emergency - Main contents
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| dossier | COM(2022)461 - Amending numerous regulations on emergency procedures for the conformity assessment, adoption of common specifications and ... |
|---|---|
| document | COM(2022)461  |
| date | September 19, 2022 |
(2) The framework established by [insert reference to SMEI Regulation] lays down measures, which should be deployed in a coherent, transparent, efficient, proportionate and timely manner, so as to prevent, mitigate and minimise the impact on the functioning of the Single Market that a crisis may cause.
(3) [insert reference to SMEI Regulation] lays down a multi-layered mechanism consisting of contingency planning, vigilance mode and Single Market emergency mode.
(4) [insert reference to SMEI Regulation] lays down rules with the objective of safeguarding the free movement of goods, services and persons in the Single Market and to ensure the availability of goods and services that are particularly important also in times of crisis. [insert reference to SMEI Regulation] applies to both goods and services.
(5) In order to complement, ensure consistency and to further enhance the effectiveness of such measures, it is appropriate to ensure that referred to in [insert reference to SMEI Regulation] may be swiftly placed on the Union market in order to contribute to addressing and mitigating the disruptions.
(6) A number of Union sectoral legal acts lay down harmonised rules regarding the design, manufacture, conformity assessment and placing on the market of certain products. Such legal acts include Regulations (EU) 2016/424 40 , (EU) 2016/425 41 , (EU) 2016/426 42 , (EU) 2019/1009 43 and (EU) No 305/2011 44 of the European Parliament and of the Council. Those legal acts are based on the principles of the new approach to technical harmonisation. Moreover, Regulations (EU) 2016/424, (EU) 2016/425, (EU) 2016/426 and (EU) 2019/1009 are also aligned to the reference provisions laid down by Decision No 768/2008/EC of the European Parliament and of the Council 45 .
(7) Neither the reference provisions laid down by Decision No 768/2008/EC, nor the specific provisions laid down by the sectoral nionU harmonisation legislation provide for procedures designed to apply in crisis. It is appropriate to introduce targeted adjustments to those Regulations, aimed at preparing and responding to impacts of crises affecting products that have been designated as crisis-relevant goods and covered by those Regulations.
(8) Experience from the recent crises that have affected the Single Market has shown that the procedures laid down in the sectoral legislation are not designed to cater for the needs of crisis-response scenarios and do not offer the necessary regulatory flexibility. It is therefore appropriate to provide for a legal basis for such crisis-response procedures as a complement to the measures adopted under [insert reference to SMEI Regulation].
(9) In order to overcome the potential effects of disruptions on the Single Market and in order to ensure that crisis-relevant goods are placed on the market swiftly, it is appropriate to provide for a requirement for the conformity assessment bodies to prioritise the conformity assessment applications of such products over any pending applications concerning products, which have not been designated as crisis-relevant.
(10) To that end, emergency procedures should be laid down in Regulations (EU) 2016/424, (EU) 2016/425, (EU) 2016/426, (EU) 2019/1009 and (EU) No 305/2011. Those procedures should be available only following the activation of the Single Market emergency mode in accordance with [insert reference to SMEI Regulation].
(11) Furthermore, in cases where the disruptions might affect the conformity assessment bodies or in cases where the testing capacities for such crisis-relevant products would not be sufficient, it is appropriate to provide for the possibility for the national competent authorities to exceptionally and temporarily authorise the placing on the market of products, which have not undergone the usual conformity assessment procedures required by the respective EU sectoral legislation.
(12) As regards products falling within the scope of those Regulations that have been designated as crisis-relevant goods, the national competent authorities should be able, in the context of an ongoing Single Market emergency, to derogate from the obligation to carry out those conformity assessment procedures laid down in those Regulations, in those cases where the involvement of a notified body is mandatory and should be able to issue authorisations for those products, provided that they comply with all the applicable essential safety requirements. Compliance with those substantive requirements may be demonstrated by various means, which may include testing performed by the national authorities of samples provided by the manufacturer having applied for an authorisation. The specific procedures, which were followed to demonstrate the compliance and their results should be clearly described in the authorisation issued by the national competent authority.
(13) Where a Single Market emergency entails an exponential increase in the demand for certain products and in order to support the efforts of economic operators to meet such demand, it is appropriate to provide technical references, which may be used by the manufacturers to design and produce crisis-relevant goods, which comply with the applicable essential health and safety requirements.
(14) A number of sectoral Union harmonisation legislation provide for the possibility for a manufacturer to benefit from a presumption of conformity if their product complies with a harmonised European standard. However, in cases where such standards do not exist or the compliance with them might be rendered excessively difficult by the disruptions caused by the crisis, it is appropriate to provide for alternative mechanisms.
(15) With respect to Regulations (EU) 2016/424, (EU) 2016/425, (EU) 2016/426 and, (EU) 2019/1009, the competent national authorities should be able to presume that products manufactured in accordance with national or international standards within the meaning of Regulation (EU) No 1025/2012 46 ensuring an equivalent level of protection to that offered by the harmonised European standards comply with the relevant essential health and safety requirements.
(16) Furthermore, with respect to Regulations (EU) 2016/424, (EU) 2016/425, (EU) 2016/426, (EU) 2019/1009 and (EU) No 305/2011, the Commission should have the possibility to adopt by means of implementing acts common specifications, on which the manufacturers may rely in order to benefit from a presumption of conformity with the applicable essential requirements. The implementing act laying down such common specifications should remain applicable for the duration of the Single Market emergency.
(17) With respect to Regulations (EU) 2016/424, (EU) 2016/425, (EU) 2016/426, (EU) 2019/1009 and (EU) No 305/2011, in exceptional and duly justified circumstances, notably in order to ensure the interoperability among products or systems, the Commission should be able to adopt by means of implementing acts common specifications laying down mandatory technical specifications, with which the manufacturers will be required to comply. The implementing act laying down such common specifications should remain applicable for the duration of the Single Market emergency.
(18) In order to ensure that the level of safety provided by the harmonised products is not compromised, it is necessary to provide for rules for enhanced market surveillance, in particular with respect to goods designated as crisis-relevant and including by enabling closer cooperation and mutual support among the market surveillance authorities.
(19) In accordance with its established practice, the Commission would systematically consult the relevant sectoral experts in the context of the early preparation of all draft implementing acts laying down common specifications.
(20) Regulations (EU) 2016/424, (EU) 2016/425, (EU) 2016/426, (EU) 2019/1009 and (EU) No 305/2011 should therefore be amended accordingly,
(21) In order for this Regulation to apply from the same date as [SMEI Regulation], its application should be deferred.