EN   EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX  
SANTE/11174/2018 (POOL/E4/2018/11174/11174-EN.doc) 
[…](2019) XXX  draft 
 
COMMISSION DELEGATED REGULATION (EU) …/... 
of XXX  
amending Regulation (EU) No 528/2012 of the European Parliament and of the Council 
to include Saccahoromyces cervisiae  as an active substance in Annex I thereto 
(Text with EEA relevance) 
 EN 1  EN EXPLANATORY MEMORANDUM 
1. CONTEXT  OF THE  DELEGATED  ACT 
Article 28(1) of Re gulation (EU) No 528/2012 (the BPR) empowers the Commission 
to adopt delegated acts in order to include an active substance into Annex I to the 
BPR after receiving the opinion of the European Chemicals Agency (ECHA), provided that there is evidence that the active substance do not give rise to concern according to the conditions set out in Artic le 28(2) of that Re gulation. A simplified 
authorisation procedure is provided in Ch apter V of the BPR for biocidal products 
containing active substances listed in Annex I to the BPR and fulfilling other conditions set out in Article 25 of that Regulation. 
Article 15(b) of Regulati on (EU) No 1062/2014 (the Re view Regulation) provided 
economic operators with an opportunity to  support those active substances that 
benefitted from the food and f eed derogation provided for by Article 6 of Regulation 
(EC) No 1451/2007. The concerned active subs tances are food and feed used in 
biocidal products of product-type 19 "R epellents and Attractants". The products 
supplied on the market as biocidal products  containing these substances do not 
benefit from the exemption of the scope of the BPR set out in Article 2(5))(a) of the 
BPR, as this exemption covers only food or  feed being placed on the market as food 
or feed in compliance with EU food or feed legislation (e.g. manufacturing, 
marketing and labelling requirements) but used by the user for biocidal purposes. As these active substances do not benefit fro m derogation under the BPR anymore, and 
following the submission of successful no tifications by economic operators pursuant 
to Articles 15 to 17 of the Review Regu lation, ECHA was able to identify potential 
candidates for inclusion into Annex I to the BPR among these substances. 
After discussion with Member States Co mpetent Authorities for Biocidal Products, 
the Commission requested on 31 January 2017 an opinion to the European Chemicals Agency in accordance with Article 75(1)(g) of Regulation (EU) No 
528/2012 as to whether each food or feed active substance for which ECHA accepted 
a declaration of interest to notify give rise to concern in accordance with Article 28(2) of the BPR.  
The opinion of the European Chemicals Agency was formulated on 14 December 
2017 by the Biocidal Products Committee and confirmed that Saccahoromyces 
cervisiae  does not give rise to concern and is eligible for inclusion in Annex I to 
Regulation (EU) No 528/2012. This opinion is considered as an opinion of the 
Agency pursuant to Article 28(1)  of Regulation (EU) No 528/2012. 
This draft Delegated Regulation therefore proposes to include Saccahoromyces 
cervisiae  in Annex I to Regulation (EU) No 528/2012. 
2. CONSULTATIONS
 PRIOR  TO THE  ADOPTION  OF THE  ACT 
The Commission has consulted an expert  group (the 'Biocides CA meeting') 
consisting of representatives of Member States' competent authorities for biocidal products, of the European Chemicals Agency , of the biocides industry and of the 
civil society in the meetings of 27- 28 September 2018, 13-15 March 2019 and 16-17 
May 2019. EN 2  EN 3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT 
The delegated act amends Annex I to Regulation (EU) No 528/2012. EN 3  EN COMMISSION DELEGATED REGULATION (EU) …/... 
of XXX  
amending Regulation (EU) No 528/2012 of th e European Parliament and of the Council 
to include Saccahoromyces cervisiae  as an active substance in Annex I thereto 
(Text with EEA relevance) 
THE EUROPEAN COMMISSION, 
Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the 
Council of 22 May 2012 concerning the making av ailable on the market and use of biocidal 
products
1, and in particular Ar ticle 28(1) thereof, 
Whereas: (1) The active substance Saccahoromyces cervisiae , insofar as it constituted food or feed 
intended for use as a repellent or attractant of product type  19, used to benefit from the 
food and feed derogation provided for in Ar ticle 6 of Commission Regulation (EC) No 
1451/2007
2.  
(2) A notification was submitted pursuant to Article 16(5) of Commission Delegated 
Regulation (EU) No 1062/20143 for Saccahoromyces cervisiae  for product type 19 
benefiting from the food and feed derogati on. The European Che micals Agency (‘the 
Agency’) declared the notification to be compliant and informed the Commission of the compliance pursuant to Ar ticle 17 of that Regulation. Saccahoromyces cervisiae  
was consequently included fo r product type 19 in the list of substance/product type 
combinations included in the programme of  review of existing active substances 
contained in biocidal products
4.  
(3) On 31 January 2017 the Commission asked the Agency for an opinion on whether 
Saccahoromyces cervisiae  gives rise to concern according to Article 28(2) of 
Regulation (EU) No 528/2012.  
                                                 
1 OJ L 167, 27.6.2012, p. 1. 
2 Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year 
work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of 
the Council concerning the placing of biocidal products on the market (OJ L 325, 11.12.2007, p. 3). 
3 Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for 
the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 1). 
4 Commission Delegated Regulation (EU) 2019/157 of 6 November 2018 amending Annex II to 
Delegated Regulation (EU) No 1062/2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 31, 1.2.2019, p. 1). EN 4  EN (4) The opinion of the Agency5 concluded that Saccahoromyces cervisiae  does not give 
rise to concern and is therefore eligible for inclusion in Annex I to Regulation (EU) No 528/2012. 
(5) Taking into account the opinion of the Agency, it is appropriate to include 
Saccahoromyces cervisiae  in Annex I to Regulation (EU) No 528/2012. As 
Saccahoromyces cervisiae  is of natural origin, it s hould be included in category 4 
"Traditionally used substances of natural origin". Saccahoromyces cervisiae  should be 
included in that Annex only insofar as it fa lls within the definition of “food” or “feed” 
referred to in point (u) of Ar ticle 3(1) of that Regulation. This is consistent with the 
fact that Saccahoromyces cervisiae  only benefited from the food and feed derogation 
provided for in Article 6 of Regulation (EC) No 1451/2007 if it was food or feed.   
(6) Article 89(3) of Regulation (EU) No 528/ 2012 contains transitional measures where 
an existing active substance included in the work programme for the systematic 
examination of existing active substances is approved in accordance with that Regulation. With respect to Saccahoromyces cervisiae  for product-type 19, the date of 
approval for the purposes of Article 89(3) of that Regula tion should be set at 1 June 
2021, in order to allow sufficient time for applications for authorisation to be 
submitted in accordance with the second s ubparagraph of Article 89(3) of that 
Regulation, 
HAS ADOPTED THIS REGULATION: 
Article 1 
Annex I to Regulation (EU) No 528/2012 is ame nded in accordance with the Annex to this 
Regulation. 
Article 2 
For the purposes of Article 89(3) of Regula tion (EU) No 528/2012, the date of approval of 
Saccahoromyces cervisiae  for product-type 19 is 1 June 2021 . 
Article 3 
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  Jean-Claude JUNCKER 
                                                 
5 Biocidal Products Committee (BPC) Opinion of 14 December 2017 on the eligibility of certain food 
and feed active substances for inclusion into Annex I to the BPR, ECHA/BPC/186/2017.