EN   EN  
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2020) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
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)  
  
EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
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)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union, 
Having regard to Regulation (EC) No 1907/2006 of the European Parliament and of the 
Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and 
Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending 
Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission 
Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC a nd Commission 
Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC1, and in particular Article 
74(1) and 132 thereof,  
Whereas:  
(1) Article 56(1) of Regulation (EC) No 1907/2006 sets out an authorisation requirement 
for the placing on the market and the use of substances of very high concern listed in 
Annex XIV to that Regulation. The compliance  with that requirement, in certain cases , 
constitute s a significant administrative burden for undertakings . In its Communication 
of 18 June 2014 “Regulatory Fitness and Performance Programme (REFIT): State of 
Play and Outlook”2 the Commission announced that it was consider ing simplifying th e 
authorisation process  in some specific cases. Simplifying the applications for 
continued use of substances of very high concern in the production of  legacy spare 
parts was identified as one of the actions  in the  Commission Communication of 5 
March 2018 “Commission General Report on the operation of REACH and review of 
certain elements”3. 
(2) The Commission Communication of 2 De cember 2015 “Closing the loop – An EU 
action plan for the Circular Economy”4 describes that the extension of the lifetime of 
products  by way of  repair  helps  avoid wastage. The Council c onclusions of 20 June 
2016 on that action plan5 invite  the Commission to investigate what initiatives can be 
taken at U nion level in the interest of extending the lifetime of products , in particular 
by promoting the availability of spare parts.  
                                                 
1 OJ L 396, 30.12.2006, p. 1  
2 COM(2014) 368 final 
3 COM(2018) 116 final 
4 COM(2015) 614 final 
5 Closing the loop - An EU action plan for the Circular Economy -  Council conclusions of 20 June 2016, 
ST 10518 2016 INIT .  
EN 2  EN (3) In order to avoid the premature obsolescence of  articles or comp lex products6 that are 
no longer produced after the sunset dates referred to in Annex XIV to Regulation (EC) 
No 1907/2006, spare parts as well as substances and mixtures that are necessary for 
the repair of such articles or complex products  need to continue to be made  available 
on the market  and used . If a substance listed in Annex XIV to Regulation (EC) No 
1907/2006 has been used to produce such articles or complex products and, if after the 
sunset date the spare part cannot be produced or the product cannot be  repair ed 
without  the use of  that substance , the requirements as regards the content of the 
application for authorisation and of the review report of an authorisation for such uses  
should be clarified in order to simplif y such  applications for aut horisation .  
(4) As regards the analysis of alternatives referred to in Article 62(4)(e) of Regulation 
(EC) No 1907/2006, providing justification  demonstrating that the article or complex  
product is no longer produced after the sunset date, that it cannot function as intended 
without the spare part and that such spare part  cannot be produced without the 
substance, or that the article or complex product cannot be repaired otherwise than by 
using the substance , should be considered sufficient to conclude on the lack of suitable 
alternatives.  As the use of the substance in the production of such spare part s or repair 
of such article s or complex product s will gradually decrease  since its intended use is 
for a product  that is no longer produced, while  the substitution costs for research and 
development, testing, qualification, and industrialisation of possible alternatives  for 
such use s are likely to be  high in view of the expected decreasing trend, such provision 
is deemed justified .  
(5) Similarly, t he justification demonstrating that the article or complex product is no 
longer produced after the sunset date, that it cannot function as intended without the 
spare part  and that such spare part cannot be produced without the substance, or that 
the article or complex product cannot be repaired otherwise than by using the 
substance should be considered sufficient in order to demonstrate the socio -economic 
benefits of the use of the substance in the socio -economic analysis referred to in point 
(a) of Article 62(5) of Regulation (EC) No 1907/2006. The non-availability of spare 
parts  or the impossibility to repair articles or complex products  no longer produced 
without that substance  would lead to the premature obsolescence of those articles or 
complex products  before the end of their lifetime  use and therefore to their premature 
disposal , likely causing high costs to operators, consumers or society . Moreover , the 
number of  uses and quantities of the substance used f or such spare parts are expected 
to decreas e, leading to a diminishing impact  on human health and the environment 
associated with the exposure to or emission of the substance used. It is therefore  
appropriate that contents of the socio -economic analysis referred to in  point (a) of 
Article 62(5) of Regulation (EC) No 1907/2006 be provided by the applicant in a 
succinct form. This  is without prejudice to the consideration of the risk posed by the 
use of the substance to human health or the environment and to  the need for the 
applicant to demonstra te that socio -economic benefits outweigh that risk.  
(6) The clarification of the content of  applications for authorisation for the use of a 
substance in the production of spare parts for repair or in the repair of articles and 
complex products no longer produc ed should result in a  reduction of the workload for 
                                                 
6 ‘Complex products’ as described  in the judgment of the Court of Justice of 10 September 2015, 
Fédération des entreprises du commerce et de la distribution (FCD) and Fédération des magasins de 
bricolage et de l’aménagement de la maison (FMB) , C-106/14, ECLI:EU:C:2015:576 , paragraphs  48-
54.  
EN 3  EN the European Chemicals Agency ( ‘the Agency’) in assessing applications for 
authorisation in those specific cases. The fees levied for  such applications should be 
proportionate to the expected workload of the Agency in such cases  and, hence, be 
reduced when compared to the fee levied for  the applications for other uses. For the 
same reasons, the charges applicable to the review of author isations granted for those 
uses should be reduced by  the same proportion.  
(7) Commission Regulation (EC) No 340/20087 should therefore be amended accordingly.  
(8) The measures provided for in this Regulation are in accordance with the opinion of the 
Committee established by Article 133 of Regulation (EC) No 1907/2006, 
HAS ADOPTED THIS REGULATION:  
Article 1  
This Regulation implements  Article s 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 part s’); 
(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 substan ce was used in the production of those articles or 
complex products  and they cannot be repaired other wise than by using that  
substance (‘repair of articles or complex products  no longer produced’).  
Article 2  
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 R egulat ion 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 
                                                 
7  Commission Regulation (EC) No 340/2008 of 16 April 2008 on the fees and charges payable to the 
European Chemicals Agency pursuant to Regulation (EC) No 1907/2006 of the European Parliament 
and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals 
(REACH) (OJ L 107 17.4.2008, p. 6).   
EN 4  EN the repair of articles or complex products  no longer produced shall be considered to 
comply wit h  point ( a) of Article  62(5)  whe n it includes the following:  
(a) a succinct description of the human health or environmental impact s in 
accordance with the information provided in the chemical safety report ; 
(b) a succin ct description of the socio -economic benefit s 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 produc ts 
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 socio -economic 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 Re gulation (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 [insert date -  14 days after date of entry into force ] the European Chemicals  
Agency (‘the Agency’)  shall make publicly available specific formats for the 
analysis of alternatives and the socio -economic 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. 
Article 3  
Regulation (EC) No 340/2008 is amended as follows:  
(1) In Article 8 (2), the following  subparagraph is added  after the fifth  subparagraph:  
‘The Agency shall levy a reduced fee as set out in point 2 of Annex VI to this 
Regulation for application s for authorisation for uses of substances in the production 
of legacy spare parts f or the repair of  articles or complex products  no longer 
produced as described in point (a) of Article 1 of Commission Implementing 
Regulation …*+  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.  
_______________ 
* Commission Implementing Regulation .../... of … on ... (OJ ...). ʼ. 
                                                 
+  OJ Please insert in the text the number of this Implementing Regulation and insert the number, date, 
title and OJ reference of th is Implementing  Regulation  in the footnote.   
EN 5  EN (2) In Article 9(2), the following subparagraph is inserted after the fourth subparagraph:  
ʻThe 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 …+ and 
in the repair of articles or complex products no longer produced as described in poi nt 
(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.  
Article 4  
This Regulation shall enter into force on the twentieth  day following that of its publication in 
the Official Journal of the European Union. 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN