EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX  
PLAN/2023/1910 
(POOL/E4/2023/1910/1910 -EN.docx)  
[…](2023) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Regulation (EU) No 528/2012 of the European Parliament and of the Council  
to include nitrogen generated from ambient air 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 Regulation (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 ( the Agency ), 
provided that there is evidence that the active substance do es not give rise to concern 
accordin g to the conditions set out in Article 28(2) of that Regulation.  A simplified 
authorisation procedure is provided in Chapter V of the BPR for biocidal products 
containing active substances  listed in Annex I to the BPR and fulfilling other 
conditions set ou t in Article 25 of that Regulation . 
Nitrogen generated in -situ is currently not approved for use in the Union and it is 
neither listed in Annex I to the BPR , nor in cluded in the review programme of 
existing active substances in biocidal products. Between 2 020 and 2022, following 
applications from ten Member States, the Commission granted derogations pursuant 
to Article 55(3) to those  Member States, allowing them to authorise the making 
available on the market and use of biocidal products consisting of in-situ generated 
nitrogen for the protection of cultural heritage until 31 December 2024.  These 
derogations were granted as the use of in -situ generated nitrogen appear ed to be the 
only effective technique for the control of harmful organisms that can be used for all 
types of materials and combinations of materials present in cultural institutions 
without damaging them.  The respective Commission Deci sions indicate that the 
inclusion of in -situ generated nitrogen in Annex I to the BPR would allow Member 
States to authorise products consisting of in -situ generated nitrogen without the need 
for a derogation.  
On 4 April 2022, the Agency  received an application for inclusion of nitrogen 
generated from ambient air as an active substance in Annex I, category 2, of  
Regulation (EU) No 528/2012, in accordance with Article 3 of Implementing 
Regulation (EU) 88/2014. This application was evaluated by the  competent authority 
of Germany.  The evaluating competent authority of Germany  submitted the 
assessment report together  with its conclusions to the Agency on 14 October  2022. 
After the submission of the assessment report, discussions took place in technical 
meetings organised by the Agency.  
The opinion of the Agency  of 1 March  2023, considered as an opinion of the Agency 
pursuant to Article 28(1) of Regulation (EU) No 528/2012 , concluded that nitrogen 
generated from ambient air  does not give rise to concern and is eligible for inclusion 
in Annex I to BPR.  
This draft Delegated Regulation therefore proposes to include nitrogen generated 
from ambient air 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' compet ent authorities for biocidal 
products, of the European Chemicals Agency, of the biocides industry and of the 
civil society  during the 101st and 102nd CA meeting s in September  2023 and 
December 2023 respectively .   
EN 2  EN 3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
The delega ted Regulation  amends Annex I to Regulation (EU) No 528/2012 . The 
legal basis  is Article 28(1) of that Regulation.   
EN 3  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Regulation (EU)  No 528/2012 of the European Parliament and of the Council  
to include nitrogen generated from ambient air 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 available on the market and use of biocidal 
products1, and in particular Article 28(1) thereof,  
Whereas:  
(1) On 4 Ap ril 2022, the European Chemicals Agency (‘the Agency’) received  an 
application  for inclusion of nitrogen generated from ambient air as an active substance  
in Annex I to Regulation (EU) No 528/2012,  submitted to it  in accordance with Article 
3(1) of Commiss ion Implementing Regulation (EU)  No 88/20142. The application was 
evaluated by the competent authority of Germany.  
(2) The evaluating competent authority submitted the assessment report together with its 
conclusions to the Agency on 14 October  2022. After the submission of the 
assessment report, discussions took place in technical meetings organised by the 
Agency.  
(3) In accordance with Article 75(1), second subparagraph, point ( c), of Regulation (EU) 
No 528/2012, the Biocidal Products Committee prepares the opinio n of the Agency 
regarding the applications for inclusion in Annex I of active substances. In accordance 
with Article 4(4) of Regulation (EU) No 88/2014 read in conjunction with Article 
75(1) and (4) of Regulation (EU) No 528/2012,  the Biocidal Products Com mittee 
adopted the opinion of the Agency on 1 March  20233, having regard to the conclusions 
of the evaluating competent authority.  
(4) In its opinion , the Agency  concluded that nitrogen generated from ambient air does not 
give rise to concern within the meaning of Article 28( 2) of Regulation (EU) No 
528/2012, and can thus be included  in Annex I  to that Regulation , provided that 
applications for product authorisations shall include evidence that exposure of the user 
and the general public to a hypoxic atmosphere is avoided and, where appropriate, the 
necessary measures are taken . 
                                                 
1 OJ L 167, 27.6.2012 , p. 1. , ELI: http://data.europa.eu/eli/reg/2012/528/2022 -04-15 
2 Commission Implementing  Regulation (EU) No 88/2014 of 31 January  2014 specifying a procedure for 
the amendment of Annex I to Regulation (EU) No 528/2012 of the European Parliament and of the 
Council conce rning the making available on the market and use of biocidal products (OJ L 32, 
1.2.2014, p. 3, ELI: http://data.europa.eu/eli/reg_impl/2014/88/oj ). 
3 Biocidal Products Committee Opinion on the application for inclusion into Annex I, Category 2  of the 
active substance nitrogen generated from ambient air ; ECHA/BPC/ 372/2023; adopted on 1 March  2023.  
EN 4  EN (5) Taking into account the opinion of the Agency , it is appropriate to include nitrogen 
generated from ambient air  in Annex I to Regulation (E U) No 528/2012 , subject to 
compliance with the condition  set out by the Agency . As nitrogen is included in 
Annex IV to Regulation (EC) No 1907/2006  of the European Parl iament and of the 
Council4, it should be included in category 2 ‘Substances included in Annex IV to 
Regulation (EC) No 1907/2006’  of Annex I to Regulation (E U) No 528/2012 . 
(6) Regulation (EU) No 528/2012  should therefore be amended accordingly , 
HAS ADOPTED THIS REGULATION:  
Article 1 
Annex I to Regulation (E U) No 528/2012  is amended in accordance with the  Annex to this 
Regulation . 
 
Article  2 
This Regulation shall enter into force on the twentieth  day following that of its publication  in 
the Official Journal o f 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  
                                                 
4 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 and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 
2000/21/EC (OJ L 396, 30.12.2006, p. 1 , ELI: http://data.e uropa.eu/eli/reg/2006/1907/2014 -04-10).