CELEX: 52013PC0288
Language: en
Date: 2013-05-16
Title: 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

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		52013PC0288
		
			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 /* COM/2013/0288 final - 2013/0150 (COD) */
			
				
		
		
			
			   	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.
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 Committee[1],
Acting in accordance with the ordinary
legislative procedure,
Whereas:
(1)       Article 19(4)(c) of
Regulation (EU) No 528/2012[2]
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/EC[3].
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 food[4] are specific migration limits.
(3)       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.
(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 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.
(5)       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.
(6)       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).
(7)       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.
(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 Agency 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 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 market[5] 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 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 the labelling and information requirements in
Article 58(3) and (4). Article 94(1) should therefore refer to Article
58(2).
(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 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.
(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:
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 respect to active
substances contained in a biocidal product in accordance with Council
Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures
for contaminants 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 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:
"(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 (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 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:
"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.";
(5)                   
in Article 45(1), the second subparagraph
is deleted;
(6)                   
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:
"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 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 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";
(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.".
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
[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.
[5]               OJ L 150, 8.6.2002, p. 71.