Commission Implementing Regulation (EU) 2021/876 of 31 May 2021 laying down rules for the application of Regulation (EC) No 1907/2006 as regards applications for authorisation and review reports for the uses of substances in the production of legacy spare parts and in the repair of articles and complex products no longer produced and amending Regulation (EC) No 340/2008 (Text with EEA relevance)
This Regulation implements Articles 61(1), 62(4)(e) and 62(5)(a) of Regulation (EC) No 1907/2006 as regards applications for authorisation and review reports for any of the following uses of a substance, on its own or in a mixture, listed in Annex XIV to that Regulation:
(a)
the production of spare parts as articles or as complex products for the repair of articles or complex products, the production of which ceased or will have ceased before the sunset date for that substance specified in Annex XIV, where that substance was used in the production of those articles or complex products and these cannot function as intended without that spare part and the spare part cannot be produced without that substance (‘production of legacy spare parts’);
(b)
the repair of articles or complex products, the production of which ceased or will have ceased before the sunset date for that substance specified in Annex XIV, where that substance was used in the production of those articles or complex products and they cannot be repaired otherwise than by using that substance (‘repair of articles or complex products no longer produced’).
1. An application for authorisation pursuant to Article 62 of Regulation (EC) No 1907/2006 for the use of a substance in the production of legacy spare parts or in the repair of articles or complex products no longer produced shall be considered to comply with point (e) of Article 62(4) of that Regulation when it includes the following:
(a)
a description and analysis of the function of the substance; and
(b)
a justification demonstrating that the conditions set out in points (a) or (b) of Article 1 of this Regulation as appropriate have been fulfilled.
2. An application for authorisation pursuant to Article 62 of Regulation (EC) No 1907/2006 for the use of a substance in the production of legacy spare parts or in the repair of articles or complex products no longer produced shall be considered to comply with point (a) of Article 62(5) of that Regulation when it includes the following:
(a)
a succinct description of the human health or environmental impacts in accordance with the information provided in the chemical safety report;
(b)
a succinct description of the socioeconomic benefits of the use applied for, including a justification demonstrating that the conditions set out in points (a) or (b) of Article 1 of this Regulation as appropriate have been fulfilled;
(c)
a conclusion based on a comparison of the risks and benefits of the use of the substance applied for, as described in points (a) and (b) of this paragraph.
3. Where the application for authorisation is submitted for the use of a substance in the production of legacy spare parts or in the repair of articles or complex products no longer produced, information referred to in paragraphs 1 and 2 of this Article, together with any third party contributions on possible alternatives submitted in accordance with Article 64(2) of Regulation (EC) No 1907/2006, shall suffice for the purpose of assessing the socioeconomic factors and the suitability of the alternatives associated with the use of the substance.
4. Paragraphs 1, 2 and 3 of this Article shall apply mutatis mutandis to review reports submitted pursuant to Article 61(1) of Regulation (EC) No 1907/2006 concerning an authorisation granted for the use of a substance in the production of legacy spare parts or in the repair of articles or complex products no longer produced.
5. By 5 July 2021 the European Chemicals Agency (‘the Agency’) shall make publicly available specific formats for the analysis of alternatives and the socioeconomic analysis to be used in applications for authorisation for uses of substances in the production of legacy spare parts or in the repair of articles or complex products no longer produced as well as in review reports concerning an authorisation granted for such uses, submitted in accordance with this Regulation, reflecting the elements referred to in paragraphs 1 and 2.
Regulation (EC) No 340/2008 is amended as follows:
(1)
in Article 8(2), the following subparagraph is added after the fourth subparagraph:
‘The Agency shall levy a reduced fee as set out in point 2 of Annex VI to this Regulation for applications for authorisation for uses of substances in the production of legacy spare parts for the repair of articles or complex products no longer produced as described in point (a) of Article 1 of Commission Implementing Regulation (EU) 2021/876 ( *1 ) and in the repair of articles or complex products no longer produced as described in point (b) of Article 1 of that Regulation, submitted in accordance with that Implementing Regulation.
( *1 ) Commission Implementing Regulation (EU) 2021/876 of 31 May 2021 laying down rules for the application of Regulation (EC) No 1907/2006 as regards applications for authorisation and review reports for the uses of substances in the production of legacy spare parts and in the repair of articles and complex products no longer produced and amending Regulation (EC) No 340/2008 (OJ 192.).’;"
(2)
in Article 9(2), the following subparagraph is inserted after the fourth subparagraph:
‘The Agency shall levy a reduced charge as set out in point 2 of Annex VII to this Regulation for applications for authorisation for uses of substances in the production of legacy spare parts for the repair of articles or complex products no longer produced as described in point (a) of Article 1 of Implementing Regulation (EU) 2021/876 and in the repair of articles or complex products no longer produced as described in point (b) of Article 1 of that Regulation, submitted in accordance with that Implementing Regulation’;
(3)
Annexes VI and VII are replaced by the text as set out in the Annex to this Regulation.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
Supplementary provisions
ANNEXSupplementary provisions
ANNEX
‘ANNEX VI
Fees for applications for an authorisation under Article 62 of Regulation (EC) No 1907/2006
1.
Fees for applications for an authorisation
Table 1
Standard fees
Base fee
EUR 54 100
Additional fee per substance
EUR 10 820
Additional fee per use
EUR 48 690
Table 2
Reduced fees for medium enterprises
Base fee
EUR 40 575
Additional fee per substance
EUR 8 115
Additional fee per use
EUR 36 518
Table 3
Reduced fees for small enterprises
Base fee
EUR 24 345
Additional fee per substance
EUR 4 869
Additional fee per use
EUR 21 911
Table 4
Reduced fees for micro enterprises
Base fee
EUR 5 410
Additional fee per substance
EUR 1 082
Additional fee per use
EUR 4 869
2.
Fees for applications for an authorisation for uses of substances in the production of legacy spare parts or in the repair of no-longer-produced articles or complex products as referred to in the fifth subparagraph of Article 8(2)
Table 1
Standard fees
Base fee
EUR 27 050
Additional fee per substance
EUR 5 410
Additional fee per use
EUR 24 345
Table 2
Reduced fees for medium enterprises
Base fee
EUR 20 287
Additional fee per substance
EUR 4 057
Additional fee per use
EUR 18 259
Table 3
Reduced fees for small enterprises
Base fee
EUR 12 172
Additional fee per substance
EUR 2 434
Additional fee per use
EUR 10 955
Table 4
Reduced fees for micro enterprises
Base fee
EUR 2 705
Additional fee per substance
EUR 541
Additional fee per use
EUR 2 434
ANNEX VII
Charges for the review of an authorisation under Article 61 of Regulation (EC) No 1907/2006
1.
Charges for the review of an authorisation
Table 1
Standard charges
Base charge
EUR 54 100
Additional charge per substance
EUR 10 820
Additional charge per use
EUR 48 690
Table 2
Reduced charges for medium enterprises
Base charge
EUR 40 575
Additional charge per substance
EUR 8 115
Additional charge per use
EUR 36 518
Table 3
Reduced charges for small enterprises
Base charge
EUR 24 345
Additional charge per substance
EUR 4 869
Additional charge per use
EUR 21 911
Table 4
Reduced charges for micro enterprises
Base charge
EUR 5 410
Additional charge per substance
EUR 1 082
Additional charge per use
EUR 4 869
2.
Charges for the review of an authorisation granted for uses of substances in the production of legacy spare parts or in the repair of no-longer-produced articles or complex products as referred to in the fifth subparagraph of Article 9(2)
Table 1
Standard charges
Base charge
EUR 27 050
Additional charge per substance
EUR 5 410
Additional charge per use
EUR 24 345
Table 2
Reduced charges for medium enterprises
Base charge
EUR 20 287
Additional charge per substance
EUR 4 057
Additional charge per use
EUR 18 259
Table 3
Reduced charges for small enterprises
Base charge
EUR 12 172
Additional charge per substance
EUR 2 434
Additional charge per use
EUR 10 955
Table 4
Reduced charges for micro enterprises
Base charge
EUR 2 705
Additional charge per substance
EUR 541
Additional charge per use
EUR 2 434
’
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