EN    EN  
 EUROPEAN 
COMMISSION  
Brussels, XXX   
CA-Dec12-Doc.3.6 
[…](2012) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX  
on changes of biocidal products authoris ed in accordance with Regulation (EU) 
No 528/2012 of the European Pa rliament and of the Council  
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX  
on changes of biocidal products authoris ed in accordance with Regulation (EU) 
No 528/2012 of the European Parliament and of the Council  
(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 Article 51 thereof, 
Whereas: (1) In order to ensure a harmonised approach, it is appr opriate to adopt provisions for 
changes of biocidal products in respect of  any of the information submitted in relation 
to the initial application for the authorisation or registrati on of biocidal products and 
biocidal product families authorised or registered in accordance with Directive 98/8/EC of the European Parliame nt and of the Council  of 16 February 1998 
concerning the placing of biocidal products on the market
2 and Regulation (EU) 
No 528/2012.  
(2) Proposed changes of biocidal products should be classifi ed in different categories, 
taking into account the extent to which they  require a re-assessme nt of the risk for 
human or animal health or th e environment and of the effica cy of the biocidal product 
or biocidal product fam ily. It is appropr iate to establish the criteria to be used for 
classifying a change of a product in one of  the categories referred to in the second 
subparagraph of Article 51(3) of Regulation (EU) No 528/2012. 
(3) In order to bring further predictability, th e European Chemicals Agency (hereinafter 
"the Agency") should issue opinions on the classification of changes of products. The 
Agency should also issue guidelines on the details of the various categories of 
changes. Those guidelines should be regularl y updated in the light of scientific and 
technical progress.  
                                                 
1 OJ L 167, 27.6.2012, p. 1. 
2  OJ L 123, 24.4.1998, p. 1.  
EN 3   EN (4) It is necessary to clarify the procedure which will lead to a decision by the 
Commission in accordance with the first subparagraph of Article 50(2) of Regulation (EU) No 528/ 2012 and, where relevant, Ar ticle 44(5) thereof.  
(5) In order to reduce the overall number of po ssible applications and to enable Member 
States, the Agency and the Commission to fo cus on those changes that have a genuine 
impact on the properties of biocidal produc ts, an annual reporting system should be 
introduced for certain changes of an admi nistrative nature. Such  changes should not 
require any prior approval and should be notified within twelve months following 
implementation. However, other types of ch anges of an administ rative nature, whose 
immediate reporting and prior examination is  necessary for the continuous supervision 
of the biocidal product concer ned should not be subject to the annual reporting system. 
(6) Each change should require a separate  submission. Grouping of changes should 
nevertheless be allowed in certai n cases, in order to facilita te the review of the changes 
and reduce the administrative  burden. Grouping of change s should be allowed only 
insofar as all concerned biocidal products  are affected by the exact same group of 
changes. 
(7) Provisions should be introdu ced regarding the role of  the coordination group 
established under Regulation (EU) No 528/2012 to increase cooperation between 
Member States and allow for the settlement  of disagreements in the evaluation of 
certain changes. 
(8) This Regulation should clarify when the authorisation holder is allowed to implement 
a given change, as such clarificati on is essential for economic operators. 
(9) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on Biocidal Products, 
HAS ADOPTED THIS REGULATION: 
CHAPTER I 
General provisions 
Article 1 
Subject matter  
This Regulation lays down provisions concer ning changes of biocidal products sought in 
accordance with Article 50(2) of Regulation (E U) No 528/2012 with regard to any of the 
information submitted in relation to the initial application for the authorisation of biocidal 
products or biocidal product families in accordance with Directive 98/8/EC and 
Regulation (EU) No 528/2012 (herei nafter 'changes of products').  
EN 4   EN Article 2 
Classification of changes of products 
1. Changes of products are classi fied in accordance with the criteria laid down in the 
Annex to this Regulation. Certain categories of  changes are listed in the tables of the 
Annex. 
2. The holder of an authorisation may request the Agency to provide an opinion on the 
classification in accordance with the criteria laid down in the Annex to this Regulation 
of a change not listed in one of the tables of that Annex. 
The opinion shall be delivered within 45 days following receipt of the request and 
payment of the fee referred to in Arti cle 80(1)(a) of Regula tion (EU) No 528/2012.  
The Agency shall publish the opinion after deletion of all information of commercial 
confidential nature. 
Article 3 
Guidelines on classification 
1. The Agency shall, after consulting the Member States, the Commission and 
interested parties, draw up guidelines on the details of the va rious categories of 
changes of products.  
2. Those guidelines shall be regularly updated, taking into account the opinions taken in 
accordance with Article 2(2), contributions fr om Member States as well as scientific 
and technical progress.  
Article 4 
Grouping of changes 
1. Where several changes of products are sought , a separate notificat ion or application 
shall be submitted in respect of each change sought. 
2. By way of derogation from paragraph 1, the following rules shall apply: 
(a) a single notification may cover a series  of proposed administrative changes 
affecting different product s in the same manner; 
(b) a single notification may cover a series  of proposed administrative changes 
affecting the same product; 
(c) a single application may cover more th an one proposed change of the same 
product in the following cases: 
1. One of the proposed changes in th e group is a major change of the 
product; all other proposed chan ges in the group are a direct 
consequence of that change. 
2. One of the proposed changes in the group is a minor change; all other 
proposed changes in the group are a di rect consequence of that change.  
EN 5   EN 3. All changes in the group are a direct  consequence of a new classification 
of the active substance(s) or non ac tive substance(s) contained in the 
product or of the product itself.  
4. All changes in the group are a direct consequence of a specific condition 
of the authorisation;  
(d) a single application may cover more than  one proposed change if the Member 
State evaluating the application in accord ance with Articles 7(4) or 8(4), or, in 
the case of a change of a Union authorisation, the Agen cy, confirms that it is 
practically feasible to handle those changes in the same procedure.  
The single applications referre d to in points (c) and (d) of the first subparagraph shall 
be made in accordance with Articles 7 or 12 where at least one of the proposed 
changes is a minor change of the produc t and none of the proposed changes is a 
major change of the product, and with Ar ticles 8 or 13 where at least one of the 
proposed changes is a major change of the product. 
Article 5 
Information requirements 
An application submitted in accordance with Article 50(2) of Regulation (EU) 
No 528/2012 shall contain the following: 
1. The relevant filled application form as available from the Register for 
Biocidal Products, which shall contain: 
(a) a list of all the authorisations a ffected by the proposed change(s); 
(b) a list indicating all the Member States  in which the product is authorised 
and the changes are sought (hereinafter the  'Member States concerned'); 
(c) for products authorised by national au thorisation, the Member State which 
evaluated the initial app lication for authorisation of the biocidal product 
or, if the changes are not sought in th at Member State, the Member State 
having been chosen by the applicant together with written confirmation 
that that Member State agrees to be  reference Member State (hereinafter 
referred to as the 'reference Member State'); 
(d) for major changes of products aut horised by union au thorisation, the 
Member State who evaluated the initial  application for authorisation of 
the biocidal product or, if the chan ges are not sought in that Member 
State, the Member State having been  chosen by the applicant together 
with written confirmation that that Me mber State agrees to evaluate the 
application of the change; 
(e) where relevant, a draft revised su mmary of the biocidal product 
characteristics in, as appropriate, 
(i) for products authorised by natio nal authorisation, the official 
language(s) of all the Member States concerned;  
EN 6   EN (ii) for products authorised by Union authorisation, one of the official 
languages of the Union, which in case of major changes must be a language accepted by the Member Stat e referred to in point (c) at 
the time of application. 
2. A description of all the changes sought, including a description of all not 
yet notified changes referred to in sec tion 2 of Title I of the Annex which 
have been made in the last twelve months. 
3. Where a change leads to or is the consequence of other changes of the 
terms of the same authorisation, a description of the relation between 
these changes. 
4. All relevant supporting documents to demonstrate that the proposed 
change would not adversely affect the conclusions previously reached 
concerning the compliance with the condi tions set out in Articles 19 or 25 
of Regulation (EU) No 528/2012. 
5. Where relevant, the opinion issued by the Agency in accordance with 
Article 3 of this Regulation. 
CHAPTER II 
Changes of products authorised by Member States 
Article 6 
Notification procedure for admin istrative changes of products 
1. The authorisation holder, or its represen tative, shall submit simultaneously to all 
Member States concerned a notification comp lying with Article 5 and, in each of 
those Member States, pay the fees payable in accordance with Article 80(2) of Regulation (EU) No 528/2012.  
2. Without prejudice to the second subparagr aph, the notificati on shall be submitted 
within twelve months following the  implementation of the change.  
In case of a change referred to in section 1 of Title 1 of the A nnex to this Regulation, 
the notification shall be submitted before the implementation of the change] 
3. Within 30 days following receipt of the notification, where one of the Member States 
concerned disagrees with the change or th e relevant fee has not been paid, that 
Member State shall inform the authorisatio n holder, or its repr esentative, and the 
other Member States concerne d that the change is reject ed and the grounds for the 
rejection.  
If, within 30 days following receipt of the notification, a Member State concerned 
has not expressed its disagreement, the change shall be deemed accepted by that Member State.   
EN 7   EN 4. Within 60 days following the receipt of th e notification, each of the Member States 
concerned which has not rejected the change  in accordance with paragraph 3 shall, 
where relevant, amend the authorisation of the biocidal product in conformity with 
the agreed change.  
Article 7 
Procedure for minor changes of products 
1. The authorisation holder, or its represen tative, shall submit simultaneously to all 
Member States concerned an appl ication complying with Article 5. 
2. Each Member State concerned shall inform  the applicant of the fee payable in 
accordance with Article 80(2)  of Regulation (EU) No 528/2012 and shall reject the 
application if the applicant fails to pay the fee within 30 days. The Member State 
concerned shall inform the applicant a nd the other Member States concerned 
accordingly. Upon receipt of the fees, the Member States concerned shall accept the application and inform the applicant accord ingly indicating the da te of acceptance. 
3. The reference Member State shall validate the application within 30 days of its 
acceptance, if it complies with the require ments laid down in Article 5 and inform 
the applicant and the Member States concerned accordingly. 
In the context of the validation referred to  in the first subpar agraph, the reference 
Member State shall not make an assessment of  the quality or the adequacy of the data 
or justifications submitted. 
Where the reference Member State considers that the application is incomplete, it 
shall inform the applicant as to what a dditional information is required for the 
application to be completed and shall set a reasonable time limit for the submission 
of that information. That time limit shall not normally exceed 45 days. 
The reference Member State shall, within  30 days of receipt of the additional 
information, validate the application if  the additional information submitted is 
sufficient to comply with the requirements laid down in Article 5. 
The reference Member State shall reject th e application if the applicant fails to 
submit the requested information within the deadline and shall inform the applicant and the Member States concerned accordingly. 
4. Within 90 days of validating an applica tion, the reference Member State shall 
evaluate the application and draft an a ssessment report and shall send its assessment 
report and, where relevant, the revi sed summary of the biocidal product 
characteristics to the Member States  concerned and to  the applicant. 
5. Where it appears that additional information is necessary to carry out the evaluation, 
the reference Member State shall ask the applicant to submit such information within a specified time limit. The period referred to in paragraph 4, shall be suspended from 
the date of the request until the date the information is received. The time limit given 
to the applicant shall not ex ceed 45 days in total unless ju stified by the nature of the 
data requested or by exceptional circumstances.  
EN 8   EN The reference Member State shall reject th e application if the applicant fails to 
submit the requested information within the deadline and shall inform the applicant and the Member States concerned accordingly. 
6. If, within 45 days of recei pt of the assessment report an d, where relevant, of the 
revised summary of the biocidal product characteristics, the Member States 
concerned express no disagreement in accordan ce with Article 10, the conclusions of 
the assessment report and, where relevant, the revised summary of the biocidal 
product characteristics shall be deem ed accepted by those Member States. 
7. Within 30 days of reaching agreement, the reference Member State shall inform the 
applicant of the decision, and the refere nce Member State and each of the Member 
States concerned shall, where relevant, am end the authorisations of the biocidal 
product in conformity with  the agreed change.  
Article 8 
Procedure for major changes of products 
1. The authorisation holder, or its represen tative, shall submit simultaneously to all 
Member States concerned an appl ication complying with Article 5. 
2. The Member States concerned shall inform  the applicant of the fees payable in 
accordance with Article 80(2)  of Regulation (EU) No 528/2012 and shall reject the 
application if the applicant fails to pay th e fee within 30 days. They shall inform the 
applicant and the other Member States concerned accordingly. Upon receipt of the 
fees, the Member States concerned sha ll accept the application and inform the 
applicant accordingly indicat ing the date of acceptance. 
3. The reference Member State shall validate the application within 30 days of its 
acceptance if it complies with the requirements  laid down in Article 5 and inform the 
applicant and the Member States concerned accordingly. 
In the context of the validation referred to  in the first subpar agraph, the reference 
Member State shall not make an assessment of  the quality or the adequacy of the data 
or justifications submitted. 
Where the reference Member State considers that the application is incomplete, it 
shall inform the applicant as to what a dditional information is required for the 
validation of the application and shall set a reasonable time limit for the submission of that information. That time limit shall not normally exceed 90 days. 
The reference Member State shall, within  30 days of receipt of the additional 
information, validate the application if it de termines that the additional information 
submitted is sufficient to comply with th e requirements laid down in Article 5. 
The reference Member State shall reject th e application if the applicant fails to 
submit the requested information within the deadline and shall inform the applicant and the Member States concerned accordingly. 
4. Within 180 days of validating an applic ation, the reference Member State shall 
evaluate the application and draft an a ssessment report and shall send its assessment  
EN 9   EN report and, where relevant, the revi sed summary of the biocidal product 
characteristics to the Member States  concerned and to the applicant.  
5. Where it appears that additional information is necessary to carry out the evaluation, 
the reference Member State shall ask the applicant to submit such information within a specified time limit. The period referred to in paragraph 4 shall be suspended from the date of the request until the date on which the information is received. The time limit given to the applicant shall not exceed 90 days in total unless it is justified by 
the nature of the data requested or by exceptional circumstances. 
The reference Member State shall reject th e application if the applicant fails to 
submit the requested information within the deadline and shall inform the applicant and the Member States concerned accordingly. 
6. If, within 90 days of recei pt of the assessment report an d, where relevant, of the 
revised summary of the biocidal product characteristics, the Member States 
concerned express no disagreement in accordan ce with Article 10, the conclusions of 
the assessment report and, wher e appropriate, the revised summary of the biocidal 
product characteristics shall be deem ed accepted by those Member States. 
7. Within 30 days of reaching agreement, the reference Member State shall inform the 
applicant of the decision, and the refere nce Member State and each of the Member 
States concerned shall, where relevant, am end the authorisations of the biocidal 
product in conformity with  the agreed change.  
Article 9 
Biocidal products authorised in accordance w ith Article 26 of Regul ation (EU) No 528/2012 
1. Where the authorisation has been granted in  accordance with Article 26 of Regulation 
(EU) No 528/2012, the authorisation holder or  its representative shall notify each 
Member State, on the territory of which the biocidal product is made available, of 
notifications or applications  made to the reference Member State in accordance with 
Articles 6, 7 or 8 of this Regulation.  
2. Where a revised summary of the biocidal product characteristics has been accepted by 
the reference Member State, the authorisation holder or its representative shall submit 
the revised summary to each Member State on the territory of which the biocidal product is made available in the offici al language(s) of that Member State. 
Article 10 
Coordination group, arbitration and de rogation from mutual recognition 
1. A Member State concerned may propose to re fuse to grant an authorisation or to 
adjust the terms and conditions of the aut horisation in accordance with Article 37 of 
Regulation (EU) No 528/2012. 
2. Where, regarding matters other than those referred to in paragraph 1, the Member 
States concerned do not reach an agreement on the conclusions of the assessment report or, where relevant, on the revise d summary of the biocidal product 
characteristics in accordance with Article 7( 6) or 8(6), or a Member State concerned  
EN 10   EN has disagreed in accordance with Article 6(3) , the reference Member State shall refer 
the matter to the coordination group referre d to in Article 35 of Regulation (EU) 
No 528/2012. 
Where a Member State concerned is in disagreement with the reference Member 
State, that Member State shall give a detail ed statement of the reasons for its position 
to all Member States concerned and to the applicant. 
3. Articles 35 and 36 of Regulation (EU) No 528/2012 shall apply to matters of 
disagreement referred  to in paragraph 1 .  
EN 11   EN CHAPTER III 
Changes of products authorised by the Commission 
Article 11 
Notification procedure for admin istrative changes of products 
1. The authorisation holder, or  its representative, shal l submit to the Agency a 
notification complying with Article 5 and pay the fee referred to in Article 80(1)(a) of Regulation (EU) No 528/2012.  
2. That notification shall be submitted within twelve months following implementation 
of the change.  
In case of a change referred to in section 1 of Title 1 of the A nnex to this Regulation, 
the notification shall be submitted before the implementation of the change. 
3. Within 30 days following receipt of the notif ication and subject to the payment of the 
relevant fee, the Agency shall prepare and submit to the Commission an opinion on the proposed change. 
4. If, within 30 days following receipt of the notification, the releva nt fee has not been 
paid, the Agency shall reject the appli cation and inform the applicant accordingly. 
An appeal may be brought, in accordance  with Article 77 of Regulation (EU) 
No 528/2012, against Agency decisions under this paragraph. 
5. The Agency shall inform the applicant of  its opinion and shall, where relevant, 
request the applicant to subm it in all the official languag es of the Union, a revised 
summary of the biocidal product characteristics.  
6. Within 30 days of the submission of its  opinion to the Commission, the Agency 
shall, where relevant, transm it to the Commission, in all th e official languages of the 
Union, the revised summary of the biocidal product characte ristics, as referred to in 
Article 22(2) of Regulation (EU) No 528/2012, as applicable. 
Article 12 
Procedure for minor changes of products 
1. The authorisation holder, or its representative, shall submit to the Agency an 
application complying with the Article 5. 
2. The Agency shall inform the applicant of  the fee payable under Article 80(1)(a) of 
Regulation (EU) No 528/2012, and shall reject the application if th e applicant fails to 
pay the fee within 30 days. It sha ll inform the applicant accordingly. 
Upon receipt of the fee, the Agency shal l accept the application and inform the 
applicant accordingly.  
EN 12   EN An appeal may be brought, in accordance with Article 77(1) of Regulation (EU) 
No 528/2012, against Agency decisions under this paragraph.   
3. The Agency shall validate the application wi thin 30 days of acceptance if it complies 
with the requirements laid down in Article 5. 
In the context of the validation referred to  in the first subparagraph, the Agency shall 
not make an assessment of the quality or th e adequacy of the data or justifications 
submitted. 
Where the Agency considers that the applic ation is incomplete, it shall inform the 
applicant as to what additional informati on is required for the completeness of the 
application and shall set a reasonable time limit for the submission of that information. That time limit shall not normally exceed 45 days. 
The Agency shall, within 30 days of recei pt of the additional information, validate 
the application if it determines that the additional information submitted is sufficient 
to comply with the requirements laid down in Article 5. 
The Agency shall reject the application if the applicant fails to submit the requested 
information within the deadline and inform  the applicant accordingly. In such cases, 
part of the fee paid in accordance with paragraph 2 shall be reimbursed. 
An appeal may be brought, in accordance with Article 77(1) of Regulation (EU) 
No 528/2012, against Agency decisions under this paragraph.   
4. Within 90 days of accepting an applicatio n as valid, the Agency shall prepare and 
submit to the Commission an opinion on the proposed change. In case of a 
favourable opinion, the Agency shall indica te whether the proposed change would 
require an amendment of the authorisation. 
The Agency shall inform the applicant of  its opinion and shall, where relevant, 
request the applicant to s ubmit in all the official languages of the Union, a draft 
revised summary of the biocid al product characteristics. 
5. Where it appears that additional information is necessary to carry out the evaluation, 
the Agency shall ask the applicant to submit such information within a specified time 
limit. The period referred to in paragraph 4 shall be suspended from the date of the 
request until the date the information is received. However, the time limit given to 
the applicant shall not exceed 45 days in total other than in exceptional cases and 
where justified by the nature of the data requested. 
6. Within 30 days of the submission of its  opinion to the Commission, the Agency 
shall, where relevant, transm it to the Commission, in all th e official languages of the 
Union, a draft revised summary of the biocid al product characteristics, as referred to 
in Article 22(2) of Regulation (EU) No 528/2012.   
EN 13   EN Article 13 
Procedure for major changes of products 
1. The authorisation holder, or its representative, shall submit to the Agency an 
application complying with Article 5.  
2. The Agency shall inform the applicant of  the fee payable under Article 80(1)(a) of 
Regulation (EU) No 528/2012, and shall reject the application if th e applicant fails to 
pay the fee within 30 days. It shall inform  the applicant and the competent authority 
of the Member State referred to in Article 5(1)(c) (hereinafter referred to as the 'evaluating competent authority') accordingly. 
Upon receipt of the fee, the Agency shal l accept the application and inform the 
applicant and the evaluating competent authority accordingly. 
An appeal may be brought, in accordance  with Article 77 of Regulation (EU) 
No 528/2012, against decisions of th e Agency under this paragraph. 
3. Within 30 days of the Agency accepting an application, the evaluating competent 
authority') shall validate the application if it complies with the requirements laid down in Article 5. 
In the context of the validation referred to  in the first subparagraph, the evaluating 
competent authority shall not make an asse ssment of the quality or the adequacy of 
the data or justifications submitted. 
The evaluating competent authority shall, within 15 days from the Agency's 
acceptance of an application, inform the applicant of the fee payable under Article 80(2) of Regulation (EU) No 528/2012 and shall reject the application if the 
applicant fails to pay th e fee within 30 days.  
4. Where the evaluating competent authority considers that the application is 
incomplete, it shall inform the applicant as to what additional information is required 
for the completeness of the application and shall set a reasonable time limit for the 
submission of that information. That time limit shall not normally exceed 90 days. 
The evaluating competent authority shall, w ithin 30 days of receipt of the additional 
information, validate the application if it de termines that the additional information 
submitted is sufficient to comply with th e requirements laid down in Article 5. 
The evaluating competent authority shall reje ct the application if the applicant fails 
to submit the requested information with in the deadline a nd shall inform the 
applicant and the Agency accordingly. In such cases, part of the fee paid in 
accordance with paragraph 2 shall be reimbursed. 
5. The evaluating competent authority shall, within 180 days of th e validation of an 
application, evaluate it and send an asse ssment report and the conclusions of its 
evaluation, including, where relevant, a draft revised summary of the product 
characteristics, to the Agency. 
Prior to submitting its conclusions to the Agency, the evaluating competent authority 
shall provide the applicant with the opportu nity to provide wr itten comments on the  
EN 14   EN conclusions of the evaluation within 30 days. The evaluating competent authority 
shall take due account of those comme nts when finalising its evaluation. 
6. Where it appears that additional informati on is necessary to carry out the evaluation, 
the evaluating competent authority shall ask the applicant to submit such information 
within a specified time limit, and shall inform the Agency accordingly. The period referred to in paragraph 2 shall be suspended from the date of the request until the date the information is received. However, the time limit given to the applicant shall not exceed 90 days in total other than in exceptional cases and where justified by the nature of the data requested. 
3. Within 90 days of receipt of the conclusi ons of the evaluation, the Agency shall 
prepare and submit to the Commission an op inion on the proposed change. In case of 
a favourable opinion, the Agency  shall indicate whether the proposed change would 
require an amendment of the authorisation. 
The Agency shall inform the applicant of  its opinion and shall, where relevant, 
request the applicant to submit, in all the official  languages of the Union, a draft 
revised summary of the biocid al product characteristics.  
4. Within 30 days of the submission of its  opinion to the Commission, the Agency 
shall, where relevant, transm it to the Commission, in all th e official languages of the 
Union, the draft revised summary of the bi ocidal product characteristics, as referred 
to in Article 22(2) of Regulation (EU) No 528/2012.  
CHAPTER IV 
Implementation of changes 
Article 14 
Administrative changes of products 
1. Administrative changes referred to in section 2 of title 1 of the Annex may be 
implemented any time before completion of the procedures laid down in Articles 6 
and 11. 
Administrative changes referred to in section 1 of title 1 of the Annex may be 
implemented at the earliest 45 days followi ng receipt of the notification submitted in 
accordance with Articles 6 and 11. 
2. Where one of the changes referred to in paragraph 1 is reject ed, the authorisation 
holder shall cease to apply the concerne d change within 30 days following 
notification of the deci sion of the relevant Member States or, in the case of changes 
of a product authorised by the Union, the Commission.  
EN 15   EN Article 15 
Minor changes of products author ised by Union authorisation 
1. Subject to a favourable opinion from th e Agency minor changes of a product 
authorised by Union authorisation may be implemented any time after the 
submission of the Agency's opinion to the Commission in accordance with Article 11(3). 
2. Where the proposed minor change of the product is rejected by the Commission in 
accordance with Article 50(2) of Regulat ion (EU) No 528/2012, the authorisation 
holder shall cease to apply the proposed change  within 30 days fo llowing notification 
of the decision of the Commission. 
Article 16 
Major changes 
Major changes may only be implemented after the relevant Member States or, in the case of 
changes of a product authorised by Union au thorisation, the Commi ssion has approved the 
change and, where relevant, amended the deci sion granting the authoris ation by the decision 
referred to in Article 50(2). 
CHAPTER V 
Final provisions 
Article 17 
Continuous monitoring of im plementation of changes  
Where requested by a Member State, the Agen cy or the Commission and for the purpose of 
monitoring biocidal products placed on the mark et, authorisation holders shall without delay 
supply the requesting authority with any informa tion related to the implementation of a given 
change. 
Article 18 
Entry into force 
This Regulation shall enter into  force on the twentieth day following that of its publication in 
the Official Journal of  the European Union . 
It shall apply from [ 1 September 2013 ]. 
 This Regulation shall be binding in  its entirety and directly applicable in all Member States.  
EN 16   EN Done at Brussels,  
 For the Commission 
 The President  José Manuel BARROSO 
EN 17   EN ANNEX: CLASSIFICATION OF CHANGES OF PRODUCTS  
Title 1 
Administrative changes of products 
An administrative change of a product is a change following which any change of the 
existing authorisation can be expected to be only administ rative within the meaning of 
Article 3(1)(aa) of Re gulation (EU) No 528/2012. 
Section 1 
Administrative changes of products requiring  prior notification before implementation 
An administrative change of a product requiri ng prior notification befo re implementation is 
an administrative change, the knowledge of whic h is important for purposes of control and 
enforcement. Such changes include those listed in the following table, provided that the conditions therein are met: 
 
Name of the biocidal  product 
1.  Changes of the name of the biocidal  product where there is no risk of 
confusion with the names of other biocidal products. 
3.  Addition of a name for the biocidal  product where there is no risk of confusion 
with the names of other biocidal products. 
Authorisation holder 
4.  Transfer of the authorisation to a new holder established in the European 
Economic Area (EEA). 
5.  Change in the name or address of the authorisation holder, which remains in the 
EEA.  
Manufacturer(s) of the active substance(s)  
6.  Addition of a manufacturer of the active substance, or change in identity, 
manufacturing location or process, where the technical equivalence of the manufacturing location and process has b een established by the Agency in 
accordance with Article 54  of Regulation (EU) No 528/2012, and the 
manufacturer or importer is listed in  accordance with Article 95(2) of 
Regulation (EU) No 528/2012. 
Biocidal product family 
7.  Authorisation as a biocidal product family of a number of authorised products 
within a frame-formulation established in accordance with Directive 98/8/EC.  
EN 18   EN Section 2 
Administrative changes of products whic h can be notified after implementation 
An administrative change of a product which can be notified after implementation is an 
administrative change, the knowledge of which is  not important for purposes of control and 
enforcement. Such changes include those listed in the following table, provided that the conditions therein are met: 
 
Authorisation holder 
1.  Change in other administrative details of the authorisation holder than the name 
and address. 
Formulator(s) of the biocidal product 
2.  Change in the name, the administrative details or the formulatinging location of 
the biocidal product formulator, where the biocidal product composition and the formulating process remain unchanged. 
3.  Deletion of a formulating location or a formulator of the biocidal product 
4.  Addition of a formulator of the biocidal product, where the biocidal product 
composition and the formulating process remain unchanged. 
Manufacturer(s) of the active substance(s)  
5.  Change in the name or the administrative details of a manufacturer of the active 
substance, where the manuf acturing location and process remain unchanged and 
the manufacturer remains listed in accordance with Article 95(2) of Regulation 
(EU) No 528/2012. 
6.  Deletion of a manufacturer or a manufacturing location of the active substance  
 Conditions of use 
7.  More precise instructions for use, where only wording but not content of 
instructions are changed. 
8.  Removal of a particular claim, such as a specific target organism or a specific use. 
9.  Removal of a category of users. 
10.  Addition, replacement or modification of a measuring or administration device 
not relevant for the risk assessment and not regarded as a risk mitigation measure. 
Classification and labelling 
11.  Change to the classification and labelling, where the change is limited to 
what is necessary to co mply with an amendment  to Regulation (EC) No 
1272/2008 of the European Parliament and of the Council3 for the purposes of its 
adaptation to technical and scientific progress.  
                                                 
3  OJ L 353, 31.12.2008, p. 1.  
EN 19   EN Title 2 
Minor changes of products 
A minor change of a product is a change, fo llowing which any change of the existing 
authorisation can be expected to be minor within the mean ing of Article 3(1)(ab) of 
Regulation (EU) No 528/ 2012, since the change of the product is not expected to affect the 
conclusion with regard to the fulfilment of the conditions of Articles 19 or 25 of that 
Regulation. Such changes include the changes lis ted in the following table, provided that the 
conditions therein are met: 
 
Composition 
1.  Replacement of a non-active substance intenti onally incorporated in the product, where: 
• The new non active-substance is not a substance of concern 
• The physical-chemical properties and the shelf- life of the product are expected to remain 
the same. 
• The risk and efficacy profile are expected to remain the same. 
• A new quantitative risk assessment is not expected to be necessary  
2.  Increase or reduction of a non- active substance intentionally incorporated in the product outside 
the authorised range of a biocidal product family, or deletion or addition of a non-active 
substance to the authorised range of a biocidal product family, where: 
• In case of addition, the ne w non-active-substance is no t a substance of concern. 
• The physical-chemical properties and the shelf-life of the product remain within those of 
the authorised range. 
• The risk and efficacy profile are expected to remain within t hose of the authorised range. 
Conditions of use 
3.  Changed instructions for use, where the ch anges do not adversely affect the exposure 
4.  Addition, replacement or modification of a meas uring or administration device relevant for the 
risk assessment and regarded as a risk mitigation measure, where: 
• The new device accurately delivers the required  dose for the biocidal product concerned 
in line with the approved conditions of use. 
• The new device is compatible with the biocidal product. 
• The change is not expected to adversely affect the exposure. 
Shelf-life and conditions of storage 
5.  Change in the shelf-life.  
6.  Change in the conditions of storage 
Pack size 
7.  
 Change in the pack size range, where: 
• New range is consistent with the dose rate and instructions for use as approved in the 
summary of the biocidal product characteristics. 
• No change of user category. 
• The same risk-mitigation measures apply.  
EN 20   EN Title 3 
Major changes of products 
A major change of a product is a change, fo llowing which any change of the existing 
authorisation can be expected to be major within the meaning of Article 3(1)(ac) of 
Regulation (EU) No 528/ 2012, since the change of the product can be expected to affect the 
conclusion with regard to the fulfilment of the conditions of Articles 19 or 25 of that 
Regulation.