Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products with regard to certain conditions for access to the market
Date: 2013-05-16
Institutions: European Commission
Subjects: market access, market approval, marketing standard, pesticide residue, plant health product

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 concerning 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) 

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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 transitional rules of the Biocidal 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  barriers  for  certain  companies  have  also  been 
identified. Finally, the Biocidal Products Regulation fails to define a protection period for data 
relating to those products 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. The 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  large  number  of  suppliers  of  biocidal  active 
substances.  It  also  defines  the  protection  periods  for  the  data  relating  to  those  biocidal 
products with the best profile. 

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2013/0150 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

amending Regulation (EU) No 528/2012 concerning 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 COUNCIL 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 European Economic and Social Committee1, 

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

(1) 

Article 19(4)(c) of Regulation (EU) No 528/20122 prohibits authorisation 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,  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/EC3. 
However, whereas biocidal products are often mixtures and sometimes articles, those 
criteria  apply  only  to  substances.  Article  19(4)(c)  of  Regulation  (EU)  No  528/2012 
should  therefore  refer  to  biocidal  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 food4 are specific migration 
limits. 

1 
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4 

OJ C 347, 18.12.2010, p. 62. 
OJ L 167, 27.6.2012, p. 1. 
OJ L 396, 30.12.2006, p.1. 
OJ L 338, 13.11.2004, p. 4. 

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(3) 

(4) 

(5) 

(6) 

(7) 

(8) 

(9) 

Since  comparative  assessments  are  not  regulated  by  Annex  VI  to  Regulation  (EU) 
No 528/2012, the reference to that Annex in Article 23(3) of that Regulation should be 
deleted. 

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  referring  to  decisions  by  all  Member  States 
concerned to grant authorisations by mutual recognition are laid down in Article 33(3) 
and Article 34(6). Article 35(3) should therefore be amended accordingly. 

The  second  subparagraph  of  Article  45(1)  of  Regulation  (EU)  No  528/2012  requires 
an  application  for  renewal  of  Union  authorisation  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 subparagraph of Article 45(3). Therefore, and 
to  ensure  consistency  with  Article  7(1),  Article  13(1),  and  Article  43(1),  the  second 
subparagraph of Article 45(1) should be deleted. 

The first and second subparagraphs of Article 60(3) of Regulation (EU) No 528/2012 
refer  to  authorisations  granted  in  accordance  with  Article  30(4),  Article  34(6)  or 
Article  44(4).  However,  the  provisions  referring  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 Article 60(3) does not indicate 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), Article 34(7), Article 36(4), 
Article 37(2), Article 37(3), and Article 44(5). 

In order to allow the preparation of applications for product authorisation by the date 
of  approval  of  an  active  substance  as  provided  for  by  the  second  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 that Regulation should 
be granted as of the day  when the Commission adopts the Regulation providing that 
the active substance is approved. 

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 Agency to take any decision, the reference to 
that Article in Article 77(1) should be deleted. 

Article  86  of  Regulation  (EU)  No  528/2012  refers  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 subparagraph of Article 89(3) requires Member States 

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OJ L 150, 8.6.2002, p. 71. 

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to  ensure  that  product  authorisations  are  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  authorisation  process,  in  particular  where  a 
disagreement on mutual recognition persists between Member States and therefore has 
to  be  submitted  to  the  Commission  for  a  decision,  it  is  appropriate  to  extend  those 
deadlines  to  three  years,  and  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  new  active  substances  which  have  been 
approved  and  existing  active  substances  which  have  not  yet  been  approved.  For  the 
purpose  of  rewarding  innovation  by  granting  such  products  access  to  the  market, 
Member States should be allowed to apply their current systems to such products until 
the  existing  active  substance  has  been  approved,  and  the  products  are  hence  eligible 
for authorisation in accordance with Regulation (EU) No 528/2012. 

(12)  Article  89(4)  and  Article  93(2)  of  Regulation  (EU)  No  528/2012  provide  phase-out 
periods for biocidal products for which no authorisation is granted. 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  authorisation  require  the 
product to be changed. 

(13)  The first and second subparagraphs 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 Regulation (EU) No 528/2012 seeks to allow placing on the market of 
articles  treated  with  biocidal  products  containing  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 
in 
Article 58(3) and (4). Article 94(1) should therefore refer to Article 58(2). 

information  requirements 

labelling  and 

the 

(15)  Article 94(1) of Regulation (EU) No 528/2012 only applies to treated articles already 
placed on the market, and will hence introduce 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 extended to include 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 submitted by 1 September 2016. In the interest of simplification, 
Article 94(2) should be merged 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 that 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  the  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 relevant 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 

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subparagraph  of  Article  95(1)  fails  to  include  studies  on  environmental  fate  and 
behaviour. Moreover, since prospective relevant persons will pay for the right to refer 
in  accordance  with  Article 63(3),  they  should  be  entitled  to  fully  benefit  from  that 
right  by  passing  it  onto  applicants  for  product  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 first subparagraph of Article 95(1) before 
it  will  be  shared  for  the  purpose  of  substantiating  applications  for  product 
authorisations.  Such  will  be  the  case  for  data  relating  to  substance/product-type 
combinations for which a decision on inclusion in Annex I to Directive 98/8/EC has 
not  been  taken  on  1  September  2013.  Article  95  of  that  Regulation  should  therefore 
refer to that date. 

(19)  Pursuant  to  Article  95(2)  of  Regulation  (EU)  No  528/2012,  the  list  published  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  Article  95.  That  possibility  should  cover  all 
persons  who  have submitted a complete dossier 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) and 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  access  to  a  dossier  by  that  person  or  the  manufacturer  or 
importer of the biocidal product. 

(21)  The  phase-out  period  for  use  of  biocidal  products  provided  for  by  the  second 
subparagraph of Article 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  Article  95  applies  to 
active  substances  listed  under  category  6  in  Annex  I.  Those  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 therefore be regulating 
all such substances. 

(23)  The description in Annex V to Regulation (EU) No 528/2012 of products used in food 
contact materials  should be consistent with the terminology  used in Regulation (EC) 
No 1935/2004. 

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(24) 

It  should  be  clarified  in  the  first  subparagraph  of  Article  96  of  Regulation  (EU) 
No 528/2012 that Directive 98/8/EC is repealed without prejudice to all provisions of 
Regulation (EU) No 528/2012 referring to Directive 98/8/EC. 

(25)  Regulation (EU) No 528/2012 should therefore be amended accordingly, 

HAVE ADOPTED THIS REGULATION: 

Regulation (EU) No 528/2012 is amended as follows:  

(1) 

Article 19 is amended as follows: 

Article 1 

(a) in paragraph 1, point (e) is replaced by the following: 

in 

for  contaminants 

"(e)  where  appropriate,  maximum  residue  limits  for  food  and  feed  have  been 
established  with  respect  to  active  substances  contained  in  a  biocidal  product  in 
accordance  with  Council  Regulation  (EEC)  No  315/93  of  8  February  1993  laying 
food*,  Regulation (EC) 
down  Community  procedures 
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 European Parliament and of the Council of 
7  May  2002  on  undesirable  substances  in  animal  feed****,  or  specific  migration 
limits  have  been  established  with  respect  to  such  active  substances  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*****. 

* 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: 

it consists of, contains or generates a substance that meets the criteria for being 

"(c) 
PBT or vPvB in accordance with Annex XIII to Regulation (EC) No 1907/2006;"; 

(c) paragraph 7 is replaced by the following: 

"7. Where appropriate, the prospective authorisation holder or its representative shall 
apply  for  the  establishment  of  maximum  residue  limits  with  respect  to  active 
substances  contained  in  a  biocidal  product  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  establishment  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 the case of a decision on an application for 
a Union authorisation, the Commission shall prohibit or restrict the making available 

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on the market or the use of a biocidal product containing an active substance that is a 
candidate for substitution where a comparative 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 sentence 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 subparagraph is replaced by the following: 

(5) 

(6) 

"While the procedure under this Article is ongoing, the Member States' obligation to 
authorise a biocidal product within three years of the date of approval, referred to in 
the first subparagraph of Article 89(3), shall be temporarily suspended."; 

in Article 45(1), the second subparagraph is deleted; 

in Article 60(3) , the first and second subparagraphs 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 first decision concerning the authorisation of 
the  product  taken  in  accordance  with  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). 

The  protection  period  for  data  submitted  with  a  view  to  the  authorisation  of  a 
biocidal product containing a new active substance shall end 15 years from the first 
day  of  the  month  following  the  first  decision  concerning  the  authorisation  of  the 
product taken in accordance with 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 easily 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 other party concerned, make publicly available, free of 
charge, the following up-to-date information 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: 

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"Article 86 

Active substance included in Annex I to Directive 98/8/EC 

The active substances for which the Commission 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 the 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  Article  20(1)  of  this 
Regulation,  and  without  prejudice  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 years 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 available on the market in its territory only of 
a biocidal product containing only existing active substances which have been or are 
being  evaluated  under  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*, but which have not yet been approved for that product-type, 
or  a  combination  of  such  substances  and  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  authorisations  for  biocidal  products  of  that 
product-type and containing that active substance are granted, modified or cancelled 
as  appropriate  in  accordance  with  this  Regulation  within  three  years  of  the  date  of 
approval."; 

(c) paragraph 4 is replaced by the following: 

"4. Where a Member State's competent authority decides to reject the application for 
authorisation of a biocidal product submitted under paragraph 3, decides not to grant 
authorisation,  or  decides  to  impose  conditions  of  the  authorisation  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  available  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 

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authorisation.  In  the  case  of  a  decision  refusing  to  grant  the  authorisation,  or 
imposing  conditions  on  the  authorisation  making  it  necessary  to  change  a  product, 
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 180 days after such a decision. 

By way of derogation from Article 17(1), a Member State may continue to apply its 
current  system  or  practice  of  making  available  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 concerning treated articles 

By  way  of  derogation  from  Article  58(2),  a  treated  article  treated  with  or 
incorporating  a  biocidal  product  containing  only  active  substances  referred  to  in 
Article 89(2) or for which an application for approval for the relevant 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 substance 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 product 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 shall make publicly available and regularly 
update  a  list  of  all  active  substances,  and  all  substances  generating  an  active 
substance,  for  which  a  dossier  complying  with  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  having  made  such  a  submission  or  a  submission  to  the 
Agency in accordance with the second subparagraph of this paragraph, and indicate 
their  role  as  specified  in  that  subparagraph,  as  well  as  the  date  of  inclusion  of  the 
substance in the list. 

A  person  established  within  the  Union  who  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 complete substance dossier, a letter of access 

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to  a  complete  substance  dossier,  or  a  reference  to  a  complete  substance  dossier  for 
which all data protection periods have expired.  

Where, for a relevant substance, no substance supplier is included in the list referred 
to in the first subparagraph, a person established within the Union who manufactures 
a biocidal product consisting of, containing or generating that relevant substance or 
places it on the market (hereinafter 'product supplier), may submit that information. 

The  Agency  shall  inform  the  submitting  supplier  of  the  fees  payable  under 
Article 80(1)  and  shall  reject  the  application  if  the  applicant  fails  to  pay  the  fee 
within 30 days. It shall inform the submitter accordingly. 

Upon  receipt  of  the  fees  payable  under  Article 80(1),  the  Agency  shall  verify 
whether the submission complies with the second subparagraph of this paragraph and 
inform the submitter accordingly. 

2. As of 1 September 2015, a biocidal product consisting of, containing or generating 
a relevant substance included in the list referred to in paragraph 1 shall not be made 
available  on  the  market  or  used  unless  either  the  substance  supplier  or  the  product 
supplier is included in the list 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, ecotoxicological and environmental fate and behaviour studies relating 
to  substances  listed  in  Annex II  to  Regulation  (EC)  No  1451/2007,  including  any 
such studies not involving tests on vertebrates. 

4.  A  substance  supplier  or  a  product  supplier  included  in  the  list  referred  to  in 
paragraph 1 to whom a letter of access has been issued for the purpose of this Article 
or a right to refer to a study has been granted 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  listed  in  Annex  II  to  Regulation  (EC) 
No 1451/2007, but for which a decision on inclusion in Annex I to Directive 98/8/EC 
has not been taken by 1 September 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,  containing  or  generating  a  relevant  substance  for 
which neither the substance supplier, nor the 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 substances 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 paragraph 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  repealed  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"; 

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(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 materials which may enter into contact with 
food.". 

This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union. 

Article 2 

This Regulation shall be binding in its entirety and directly applicable in all Member States. 

Done at Brussels,  

For the European Parliament 
The President 

For the Council 
The President 

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