EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, 16.5.2013  
COM(2013) 288 final 
2013/0150 (COD) 
  
Proposal for a 
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
amending Regulation (EU) No 528/2012 concer ning the making availa ble on the market 
and use of biocidal products with regard to certain conditions for access to the market 
(Text with EEA relevance) 
 EN 2   EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  PROPOSAL 
The proposal relates to the recently adopted Regulation (EU) No 528/2012 ('the Biocidal 
Products Regulation'), which has not yet become applicable. An analysis of the Biocidal 
Products Regulation has shown that  certain provisions will lead to unforeseen consequences.  
The main problem identified is that the trans itional rules of the Bioc idal Products Regulation 
will introduce an un-intended market freeze of up to eleven years for articles treated with 
biocidal substances which are legal on the EU market, but which have not yet been evaluated 
at EU level. Other un-intended market barr iers for certain companies have also been 
identified. Finally, the Biocidal Products Regulation fails to defi ne a protection period for data 
relating to those produc ts with the most favourable risk profile. 
2. RESULTS  OF CONSULTATIONS  WITH  THE  INTERESTED  PARTIES  AND  
IMPACT  ASSESSMENTS 
Stakeholders and experts have been consulted in  several meetings of the expert group named 
Competent authorities for biocidal products. Th e proposal has received broad support in those 
meetings. 
3. LEGAL  ELEMENTS  OF THE  PROPOSAL 
The proposal contains provisions that will remove market barriers for suppliers of new articles 
treated with biocidal products and for a la rge number of suppliers of biocidal active 
substances. It also defines th e protection periods for the data  relating to those biocidal 
products with the best profile. EN 3   EN 2013/0150 (COD) 
Proposal for a 
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
amending Regulation (EU) No 528/2012 concern ing the making available on the market 
and use of biocidal products with regard to certain conditions for access to the market 
(Text with EEA relevance) 
THE EUROPEAN PARLIAMENT AND THE CO UNCIL OF THE EUROPEAN UNION, 
Having regard to the Treaty on the Functioning of the European Union, and in particular 
Article 114 thereof, 
Having regard to the proposal from the European Commission, 
After transmission of the draft legislative act to the national Parliaments, Having regard to the opinion of the Eu ropean Economic and Social Committee
1, 
Acting in accordance with the or dinary legislative procedure, 
Whereas: (1) Article 19(4)(c) of Regulation (EU) No 528/2012
2 prohibits authoris ation for making 
available for use by the general public of biocidal products meeting the criteria for 
being persistent, bioaccumulative and toxic ('PBT'), or very persistent and very 
bioaccumulative ('vPvB') in accordance with Annex XIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Aut horisation and Restriction of Chemicals 
(REACH), establishing a European Ch emicals Agency, amending Directive 
1999/45/EC and repealing Council Regula tion (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
3. 
However, whereas biocidal products are ofte n mixtures and sometimes articles, those 
criteria apply only to subs tances. Article 19(4)(c) of Regulation (EU) No 528/2012 
should therefore refer to bi ocidal products consisting of , containing or generating 
substances meeting those criteria. 
(2) In Article 19(1)(e) and Article 19(7) of Regulation (EU) No 528/2012, it should be 
clarified that the limits required to be established in accordance with Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on 
materials and articles intended to come into contact with food
4 are specific migration 
limits. 
                                                 
1 OJ C 347, 18.12.2010, p. 62. 
2 OJ L 167, 27.6.2012, p. 1. 
3 OJ L 396, 30.12.2006, p.1. 
4 OJ L 338, 13.11.2004, p. 4. EN 4   EN (3) Since comparative assessments are not regulated by Annex VI to Regulation (EU) 
No 528/2012, the reference to that Annex in Ar ticle 23(3) of that Regulation should be 
deleted. 
(4) According to Article 35(3 ) of Regulation (EU) No 528/ 2012, where all Member States 
concerned have reached an agreement with  the reference Member State on mutual 
recognition, a product is to be authorised  in accordance with Article 33(4) or 
Article 34(6). However, the provisions refe rring to decisions by all Member States 
concerned to grant authorisa tions by mutual recognition ar e laid down in Article 33(3) 
and Article 34(6). Article 35(3) should  therefore be amended accordingly. 
(5) The second subparagraph of Article 45( 1) of Regulation (EU) No 528/2012 requires 
an application for renewal of Union aut horisation to be accompanied by the fees 
payable under Article 80(1). However, fees  can only be paid subsequent to the 
information about their level provided by the European Chemicals Agency (hereinafter 
'Agency') in accordance with the second subpa ragraph of Article 45(3). Therefore, and 
to ensure consistency with Article 7(1), Article 13(1), and Artic le 43(1), the second 
subparagraph of Article 45(1) should be deleted. 
(6) The first and second subpa ragraphs of Article 60(3) of  Regulation (EU) No 528/2012 
refer to authorisations granted in accord ance with Article 30(4), Article 34(6) or 
Article 44(4). However, the provisions referri ng to decisions to grant authorisations 
are laid down in Article 30(1), Article 33(3), Article 33(4), Article 34(6), Article 34(7), Article 36(4) , Article 37(2), Article 37 (3), and Article 44(5). 
Furthermore, the second subparagraph of Artic le 60(3) does not indi cate any period for 
protection of data referred to in Article 20(1)(b) submitted in an application pursuant to Article 26(1). Article 60(3) should therefore also  refer to Article 26(3), 
Article 30(1), Article 33(3), Article 33(4), Article 34(6), Ar ticle 34(7), Article 36(4), 
Article 37(2), Article 37(3), and Article 44(5). 
(7) In order to allow the prep aration of applications for product authorisation by the date 
of approval of an active substance as pr ovided for by the sec ond subparagraph of 
Article 89(3) of Regulation (EU) No 528/2012, the electronic public access to 
information on active substances provided for by Article 67 of th at Regulation should 
be granted as of the day when the Commission adopts th e Regulation providing that 
the active substance is approved. 
(8) The first subparagraph of Article 77(1) of Regulation (EU) No 528/2012 provides for 
appeals against decisions of the Agency taken pursuant to Article 26(2). However, 
since Article 26(2) does not empower the Agen cy to take any decision, the reference to 
that Article in Article 77(1) should be deleted. 
(9) Article 86 of Regulation (EU) No 528/2012 re fers to active substances included in 
Annex I to Directive 98/8/EC
 of the European Parliament  and of the Council of 16 
February 1998 concerning the placing of biocidal products on the market5 It should be 
clarified that the provision applies to all active substances for which the Commission 
has adopted a Directive including them in  that Annex, that the conditions for an 
inclusion is applicable to an approval, and that the approval  date is considered to be 
the date of inclusion. 
(10) The first subparagraph of Article 89( 2) of Regulation (EU)  No 528/2012 allows 
Member States to apply their current system  until two years after the date of approval 
of an active substance. The first subparagra ph of Article 89(3) requires Member States 
                                                 
5 OJ L 150, 8.6.2002, p. 71. EN 5   EN to ensure that product authorisations ar e granted, modified or  cancelled within two 
years of approval of an active substance.  However, taking into account the time 
required for the various steps of the author isation process, in particular where a 
disagreement on mutual recognition persists between Member States  and therefore has 
to be submitted to the Commission for a d ecision, it is appropriate to extend those 
deadlines to three years, a nd to reflect that extension in the second subparagraph of 
Article 37(3). 
(11) The first subparagraph of Article 89( 2) of Regulation (EU)  No 528/2012 allows 
Member States to apply their current system  to existing active substances. A biocidal 
product may contain a combination of ne w active substances which have been 
approved and existing active substances wh ich have not yet been approved. For the 
purpose of rewarding innovation by granti ng such products acce ss to the market, 
Member States should be allowed to apply th eir current systems to such products until 
the existing active substance has been appr oved, and the products are hence eligible 
for authorisation in accordance w ith Regulation (EU) No 528/2012. 
(12) Article 89(4) and Article 93(2) of Re gulation (EU) No 528/ 2012 provide phase-out 
periods for biocidal products for which no authorisation is gran ted. The same periods 
should apply for phasing out the existing form  of a product already on the market, 
where an authorisation is granted but the conditions of the aut horisation require the 
product to be changed. 
(13) The first and second subpara graphs of Article 93(2) should  clarify that the derogation 
provided for therein applies only subject  to Member States' national rules. 
(14) Article 94(1) of Regulati on (EU) No 528/2012 seeks to allo w placing on the market of 
articles treated with biocidal products cont aining active substances which, albeit not 
yet approved, are being evaluated, either in the context of the work programme 
referred to in Article 89(1) or based on an  application submitted pursuant to Article 
94(1). However, the reference to the entire  Article 58 could be interpreted as an 
unintended derogation from the labell ing and information requirements in 
Article 58(3) and (4). Article 94(1) s hould therefore refer to Article 58(2). 
(15) Article 94(1) of Regulat ion (EU) No 528/2012 only applies to treated articles already 
placed on the market, and will hence introduc e an unintended ban on most new treated 
articles, lasting from 1 September 2013 until the approval of the last active substance contained in the articles. Its scope should therefore be exte nded to includ e new treated 
articles. Article 94(1) should also provide for a phasing-out period for treated articles 
for which no application for the approval of  the active substance for the relevant 
product-type will be submitte d by 1 September 2016. In the interest of simplification, 
Article 94(2) should be me rged with Article 94(1). 
(16) The first subparagraph of Article 95(1) of Regulation (EU) No  528/2012 prescribes the 
submission of a complete substance dossier. It  should be clarified th at such a complete 
dossier may include data referred to in Annex IIIA or IVA to Directive 98/8/EC. 
(17) The third subparagraph of Article 95(1 ) of Regulation (EU) No 528/2012 intends to 
extend the right to refer to data provided in the second subparagraph of Article 63(3) 
to all studies required for th e human health and environmental risk assessment, in 
order to allow prospective relevant persons to be included in the list referred to in 
Article 95(2). Without such a right to refer,  many prospective rele vant persons will not 
have time to comply with Article 95(1) by such time as required in order to be 
included in the list by the date referred to in Article 95(3). However, the third EN 6   EN subparagraph of Article 95(1) fails to in clude studies on envi ronmental fate and 
behaviour. Moreover, since pros pective relevant persons will  pay for the right to refer 
in accordance with Arti cle 63(3), they should be entitl ed to fully benefit from that 
right by passing it onto applicants for pr oduct authorisation. This Article should 
therefore be amended accordingly. 
(18) The fifth subparagraph of Article 95(1)  of Regulation (EU) No 528/2012 intends to 
limit the protection period for data which can  be shared already as of 1 September 
2013 for the purpose of compliance with the fi rst subparagraph of Article 95(1) before 
it will be shared for th e purpose of substantiati ng applications for product 
authorisations. Such will be the case for data relating to substance/product-type 
combinations for which a decision on inclus ion in Annex I to Di rective 98/8/EC has 
not been taken on 1 September 2013. Article 95  of that Regulati on should therefore 
refer to that date. 
(19) Pursuant to Article 95( 2) of Regulation (EU) No 528/ 2012, the list pub lished by the 
Agency is to contain the names of the participants in the work programme referred to in Article 89(1). The provision aims to allow those participants to benefit from the cost 
compensation mechanism set forth by Articl e 95. That possibility should cover all 
persons who have submitted a complete dossi er in accordance with Regulation (EU) 
No 528/2012 or with Directive 98/8/EC, or a letter of access to such a dossier. It should also cover dossiers submitted for any substance which is not itself an active 
substance, but which generates such active substances. 
(20) The first subparagraph of  Article 95(3) of Regulation (EU) No 528/2012 prohibits the 
placing on the market of biocidal products containing active substances for which the 
manufacturer or importer (the 'relevant person' ) is not included in the list referred to in 
that Article. By virtue of Article 89(2) a nd Article 93(2), certain active substances will 
be legally on the market in biocidal products although no complete dossier has yet 
been submitted. The prohibition should not apply to such substances. Furthermore, 
where no substance manufacturer or importer is listed for a substance for which a 
complete dossier has been submitted, another person should be allowed to place biocidal products containing that substance on the market, subject to the submission of 
a dossier or a letter of acces s to a dossier by that person or the manufacturer or 
importer of the biocidal product. 
(21) The phase-out period for use of biocid al products provided for by the second 
subparagraph of Artic le 95(3) of Regulation (EU) No 528/2012 should depend on the 
time when the substance is included in the list. 
(22) Article 95(4) of Regulation (EU) No 528/ 2012 stipulates that Ar ticle 95 applies to 
active substances listed unde r category 6 in Annex I. T hose substances have been 
included in Annex I based on submissions of complete dossiers, the owners of which 
should be entitled to benefit from the cost  compensation mechanism installed by that 
Article. In the future, other substances may be included in Annex I based on such 
submissions. Category 6 in Annex I to that Regulation should theref ore be regulating 
all such substances. 
(23) The description in Annex V to Regulati on (EU) No 528/2012 of products used in food 
contact materials should be consistent with  the terminology used in Regulation (EC) 
No 1935/2004. EN 7   EN (24) It should be clarified in the first subparagraph of Article 96 of Regulation (EU) 
No 528/2012 that Directive 98/8/EC is repeal ed without prejudice to  all provisions of 
Regulation (EU) No 528/2012 refe rring to Directive 98/8/EC. 
(25) Regulation (EU) No  528/2012 should therefore be amended accordingly, 
HAVE ADOPTED THIS REGULATION: 
Article 1 
Regulation (EU) No 528/2012 is  amended as follows:  
(1) Article 19 is amended as follows: 
(a) in paragraph 1, point (e) is  replaced by the following: 
"(e) where appropriate, maximum residue  limits for food and feed have been 
established with resp ect to active substances contai ned in a biocidal product in 
accordance with Council Regulation (EEC ) No 315/93 of 8 February 1993 laying 
down Community procedures for cont aminants in food*, Regulation (EC) 
No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal 
origin**, Regulation (EC) No 470/2009 of the European Parliament and of the 
Council of 6 May 2009 laying down Community procedures for the establishment of 
residue limits of pharmacologically active substances in foodstuffs of animal 
origin*** or Directive 2002/32/EC of the Eu ropean Parliament and of the Council of 
7 May 2002 on undesirable substances in an imal feed****, or specific migration 
limits have been established with respect to such active substances in accordance 
with Regulation (EC) No 1935/2004 of the Eu ropean Parliament and of the Council 
of 27 October 2004 on materials and articles intended to come into contact with 
food*****. 
* OJ L 37, 13.2.1993, p. 1. ** OJ L 70, 16.3.2005, p. 1. 
*** OJ L 152, 16.6.2009, p. 11. 
**** OJ L 140, 30.5.2002, p. 10. ***** OJ L 338, 13.11.2004, p. 4. "; (b) in paragraph 4, point (c) is  replaced by the following: 
"(c) it consists of, contains or generates a substance that meets the criteria for being 
PBT or vPvB in accordance with Annex XIII to Regulation (E C) No 1907/2006;"; 
(c) paragraph 7 is replaced by the following: "7. Where appropriate, the prospective author isation holder or its representative shall 
apply for the establishment of maximum residue limits with respect to active substances contained in a biocidal pr oduct in accordance with Regulation (EEC) 
No 315/93, Regulation (EC) No 396/2005, Regulation (EC) No 470/2009 or Directive 2002/32/EC, or for the establis hment of specific migration limits with 
respect to such substances in accordance with Regulation (EC) No 1935/2004."; 
(2) in Article 23(3), the introductory sentence is replaced by the following: 
"The receiving competent authority or, in th e case of a decision on an application for 
a Union authorisation, the Commission shall prohibit or restrict the making available EN 8   EN on the market or the use of a biocidal produc t containing an active substance that is a 
candidate for substitution where a comp arative assessment performed in accordance 
with the technical guidance notes referred to  in Article 24 demonstrates that both of 
the following criteria are met:"; 
(3) in Article 35(3), the fourth senten ce is replaced by the following: 
"The procedure shall then be considered to be closed and the reference Member State 
and each of the Member States concerned shall authorise the biocidal product in 
accordance with Article 33(3) or Article 34(6) as appropriate."; 
(4) in Article 37(3), the second subpara graph is replaced by the following: 
"While the procedure under this Article is  ongoing, the Member States' obligation to 
authorise a biocidal product within three year s of the date of appr oval, referred to in 
the first subparagraph of Article 89(3) , shall be temporarily suspended."; 
(5) in Article 45(1), the seco nd subparagraph is deleted; 
(6) in Article 60(3) , the first and second s ubparagraphs are replaced by the following: 
"The protection period for data submitted with a view to the authorisation of a 
biocidal product containing only existing active substances  shall end 10 years from 
the first day of the month following the firs t decision concerning the authorisation of 
the product taken in accordance with Ar ticle 26(3), Article 30(1), Article 33(3), 
Article 33(4), Article 34(6),  Article 34(7), Article 36(4), Article 37(2), Article 37(3), 
or Article 44(5). 
The protection period for data submitted with a view to the authorisation of a 
biocidal product containing a new active su bstance shall end 15 years from the first 
day of the month following the first deci sion concerning the authorisation of the 
product taken in accordance w ith Article 26(3), Article 30( 1), Article 33 (3), Article 
33(4), Article 34(6), Article 34(7), Article 36(4), Article 37(2), Article 37(3), or 
Article 44(5)."; 
(7) in Article 67(1), the introductory sentence is replaced by the following: 
"From the date on which the Commission adopts a Regulation in accordance with 
Article 9(1)(a), the following up-to-date information held by the Agency or the 
Commission on that active substance shall be  made publicly and ea sily available free 
of charge:"; 
(8) in Article 67(3), the introductory sentence is replaced by the following: 
"From the date on which the Commission adopts a Regulation in accordance with 
Article 9(1)(a), the Agency shall, except where the data supplier submits a justification in accordance with Article 66(4) accepted as valid by the competent 
authority or the Agency as to why such publication is potentially harmful for its 
commercial interests or any ot her party concerned, make pub licly available, free of 
charge, the following up-to-date in formation on active substances:"; 
(9) in Article 77(1), the first subparagraph is replaced by the following: 
"Appeals against decisions of the Agency taken pursuant to Article 7(2), Article 
13(3), Article 43(2), Article 45(3), Article  54(3), Article 54(4) and Article 54(5), 
Article 63(3) and Article 64(1) shall lie with the Board of Appeal set up in accordance with Regulation (EC) No 1907/2006."; 
(10) Article 86 is replaced by the following: EN 9   EN "Article 86 
Active substance included in A nnex I to Directive 98/8/EC 
The active substances for which the Comm ission has adopted a Directive including 
them in Annex I to Directive 98/8/EC shall be deemed to have been approved, under this Regulation on the date of inclusion, and shall be included in th e list referred to in 
Article 9(2). The approval shall be subject to the conditions set out in those Commission Directives."; 
(11) Article 89 is amended as follows: 
(a) in paragraph 2, the first subparagraph is replaced by the following: "By way of derogation from Article 17(1), Article 19(1) and Arti cle 20(1) of this 
Regulation, and without prejud ice to paragraphs 1 and 3 of  this Article, a Member 
State may continue to apply its current system or practice of making a given biocidal 
product available on the market until three year s after the date of approval of the last 
of the active substances to be approved in that biocidal product. It may, according to 
its national rules, authorise the making availa ble on the market in its territory only of 
a biocidal product containing only existing ac tive substances which have been or are 
being evaluated under Commission Regul ation (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*, but wh ich have not yet been appr oved for that product-type, 
or a combination of such substances a nd active substances approved in accordance 
with this Regulation. 
* OJ L 325, 11.12.2007, p. 3."; (b) in paragraph 3, the first subparagraph is replaced by the following: "Following a decision to approve a particular  active substance for a specific product-
type Member States shall ensure that aut horisations for biocidal products of that 
product-type and containing that active subs tance are granted, modified or cancelled 
as appropriate in accordance with this Regul ation within three years of the date of 
approval."; 
(c) paragraph 4 is replaced by the following: "4. Where a Member State's competent author ity decides to reject the application for 
authorisation of a biocidal product submitte d under paragraph 3, decides not to grant 
authorisation, or decides to impose c onditions of the aut horisation making it 
necessary to change a product,  the following shall apply:  
(a) the biocidal product which has not been authorised or, where relevant, which does 
not comply with the conditions of the authorisation, shall no longer be made available on the market with effect from 180 days after the date of the decision of the 
authority; 
(b) disposal and use of existing stocks of the biocidal product may continue until 365 
days after the date of the decision of the authority."; 
(12) in Article 93(2), the first and second subparagraphs are replaced by the following: 
"By way of derogation from Article 17(1), a Member State may continue to apply its 
current system or practice of making av ailable on the market biocidal products 
referred to in paragraph 1 of this Article for which an application was submitted in accordance with paragraph 1 of this Article until the date of the decision granting the EN 10   EN authorisation. In the case of a decision refusing to grant the authorisation, or 
imposing conditions on the authorisation ma king it necessary to change a product, 
the biocidal product which has not been au thorised or, where relevant, which does 
not comply with the conditions of the authorisation, shall no longer be made available on the market 180 da ys after such a decision. 
By way of derogation from Ar ticle 17(1), a Member State may continue to apply its 
current system or practice of making av ailable on the market biocidal products 
referred to in paragraph 1 of this Article for which an application was not submitted in accordance with paragraph 1 of this Article until 180 days  after 1 September 
2017." 
(13) Articles 94 and 95 are replaced by the following: 
"Article 94 
Transitional measures con cerning treated articles 
By way of derogation from Article 58(2 ), a treated article treated with or 
incorporating a biocidal product containi ng only active substances referred to in 
Article 89(2) or for which an application fo r approval for the releva nt product type is 
submitted at the latest by 1 September 2016, or only a combination of such substances and active substances referred to in Article 58(2), may be placed on the 
market until either of the following dates: 
1. in the absence of a decision not to approve one of the active substances for the 
relevant use, until the date of approval for the relevant product type and use of the last active substa nce contained in the biocidal product,  
2. in the case of a decision not to approve  one of the active substances for the 
relevant use, until 180 days after such a decision. 
By further way of derogation from Article 58(2), a treated article treated with or 
incorporating a biocidal produc t containing any other substance than those referred to 
in that Article or in paragraph 1 of this  Article may be placed on the market until 
1 March 2017. 
Article 95 
Transitional measures concerning access to the active substance dossier  
1. As of 1 September 2013, the Agency shal l make publicly available and regularly 
update a list of all active substances, a nd all substances generating an active 
substance, for which a dossier complying w ith Annex II to this Regulation or with 
Annex IVA or IIA to Directive 98/8/EC and, where relevant, IIIA thereto (hereinafter 'complete substance dossier') has been submitted and accepted or validated by a Member State in a procedure provided for by this Regulation or that 
Directive (hereinafter 'relevant substances') . For each relevant substance, the list shall 
also include all persons ha ving made such a submission or a submission to the 
Agency in accordance with the second subpa ragraph of this paragraph, and indicate 
their role as specified in th at subparagraph, as well as th e date of inclusion of the 
substance in the list. 
A person established within the Union w ho manufactures or imports a relevant 
substance, on its own or in biocidal products , (hereinafter 'substance supplier') may at 
any time submit to the Agency either a comple te substance dossier, a letter of access EN 11   EN to a complete substance dossier, or a refe rence to a complete substance dossier for 
which all data protection periods have expired.  
Where, for a relevant substance, no substan ce supplier is included in the list referred 
to in the first subparagraph, a person esta blished within the Un ion who manufactures 
a biocidal product consisting of, containing or  generating that relevant substance or 
places it on the market (hereinafter 'produc t supplier), may submit that information. 
The Agency shall inform the submitting supplier of the fees payable under 
Article 80(1) and shall reject the applica tion if the applicant fails to pay the fee 
within 30 days. It shall inform the submitter accordingly. 
Upon receipt of the fees payable under Ar ticle 80(1), the Agency shall verify 
whether the submission complies with the s econd subparagraph of this paragraph and 
inform the submitter accordingly. 
2. As of 1 September 2015, a biocidal produc t consisting of, cont aining or generating 
a relevant substance included in the list refe rred to in paragraph 1 shall not be made 
available on the market or used unless e ither the substance supplier or the product 
supplier is included in the lis t referred to in paragraph 1. 
3. For the purposes of making a submission in accordance with the second 
subparagraph of paragraph 1, Article 63(3) of this Regulation shall apply to all 
toxicological, ecotoxi cological and environmental fate  and behaviour studies relating 
to substances listed in  Annex II to Regulation (E C) No 1451/2007, including any 
such studies not involving  tests on vertebrates. 
4. A substance supplier or a product supplie r included in the lis t referred to in 
paragraph 1 to whom a letter of access has been issued fo r the purpose of this Article 
or a right to refer to a study has been gran ted in accordance with paragraph 3 shall be 
entitled to allow applicants for the authorisation of a biocidal product to make 
reference to that letter of access or that  study for the purposes of Article 20(1). 
5. By way of derogation from Article 60, all data protection periods for 
substance/product-type combinations lis ted in Annex II to Regulation (EC) 
No 1451/2007, but for which a decision on inclus ion in Annex I to Directive 98/8/EC 
has not been taken by 1 Septembe r 2013, shall end on 31 December 2025. 
6. By way of derogation from paragraph 2, disposal and use of existing stocks of 
biocidal products consisting of, containi ng or generating a relevant substance for 
which neither the substance supplier, nor th e product supplier is included in the list 
referred to in paragraph 1 may continue  until 1 September 2016 or until one year 
after the inclusion of the substance in  the list, whichever is the later. 
7. Paragraphs 1 to 6 shall not apply to subs tances listed in Annex I in categories 1 to 
5 and 7 or to biocidal products containing only such substances."; 
(14) in Article 96, the first paragr aph is replaced by the following: 
"Without prejudice to Article 86, Article 89 to Article 93 and Article 95 of this 
Regulation, Directive 98/8/EC is hereby re pealed with effect  from 1 September 
2013." 
(15) in Annex I, the entry named Category 6 is replaced by the following: 
"Category 6 – Substances for which a complete substance dossier has been 
submitted"; EN 12   EN (16) in Annex V the second paragraph under the heading "Product-type 4: Food and feed 
area" is replaced by the following: 
"Products used to be incorporated into ma terials which may ente r into contact with 
food.". 
Article 2 
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 European Parliament For the Council 
The President The President