# EUR-Lex - 52011PC0498 - EN

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# 52011PC0498

**COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT pursuant to Article 294(6) of the Treaty on the Functioning of the European Union concerning the position of the Council on the adoption of a Regulation of the European Parliament and of the Council concerning the placing on the market and use of biocidal products /* COM/2011/0498 final - 2009/0076 (COD) */**

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2009/0076 (COD)

COMMUNICATION FROM THE COMMISSION TO
THE EUROPEAN PARLIAMENT pursuant to Article 294(6) of the Treaty on the
Functioning of the European Union concerning the

position of the Council on the adoption of
a Regulation of the European Parliament and of the Council concerning the
placing on the market and use of biocidal products

1.
Background

Please note that this Communication refers
to the title of the Regulation and the numbers of articles as they were
presented in the text of the political agreement (17474/10).

Date of transmission of the proposal to the European Parliament and to the Council (document COM(2009) 267 final – 2009/0076 COD): || 12 June 2009

Date of the opinion of the European Economic and Social Committee: || 17 February 2010

Date of the opinion of the European Parliament, first reading: || 22 September 2010

Date of adoption of the position of the Council: || 21 June 2011

2.
Objective of the proposal from the Commission

The objective of the proposal is to improve
the functioning of the internal market through further harmonisation of the
rules on the authorisation and mutual recognition of biocidal products, whilst
ensuring a high level of protection of both human and animal health and the
environment.

3.
Comments on the position of the Council
3.1.
General comments

The European Parliament gave its opinion at
first reading on 22 September 2010. The Commission accepted in full, in part or
in principle 193 of the 309 amendments adopted by the European Parliament in
its first reading. Around half of these 193 amendments are already reflected,
at least in part, in the common position. The position of the Commission on the
amendments adopted by the European Parliament in its first reading is set out
in document SP(2010)7193.

The Commission accepted amendments, either
fully or in principle or in part, which would clarify the context of the
proposal or further improve it. These include, in particular, modifications to
the definition of biocidal products, the scope of derogations under exclusion
criteria, the extension of the scope of the Union authorisation, the criteria
for low-risk biocidal products and the provisions on treated articles.

The Commission rejected amendments which
would alter the nature of the proposal, such as amendments which lower the
level of environmental and human health protection or undermine the internal
market in biocidal products. It also rejected amendments that are practically
or technically not feasible or pose an unnecessary burden for the industry and
the competent authorities.

The Commission considers that the common
position does not alter the key objectives of the proposal and can thus support
it. Nevertheless, the Commission considers that certain aspects of the text should
be improved and would be happy to work with the other institutions in order to
make such improvements. In particular, with regard to the procedures foreseen
for the establishment of Maximum Residue Levels, the wording of the common
position is not compatible with Regulation (EC) No 470/2009 and this inconsistency
should be addressed as a priority.

3.2.
Detailed comments
3.2.1.
Parliamentary amendments accepted in full, in
part or in principle by the Commission and incorporated in full, in part or in
principle in the common position

Amendments 1, 4-7, 9-10, 13, 21-23, 25, 27,
30-35, 37-39, 43-44, 49, 53, 55, 56, 58, 62-63, 70, 75, 79, 80, 82-83, 85-91,
93-96, 112, 115, 116, 123-125, 137, 139, 142-144, 160-161, 165, 167-172,
178-181, 183-187, 189-190, 194, 199, 206-215, 218-220, 225-232, 234-235, 239,
241-242, 247-249, 255-257, 266-267, 269, 272, 275-277, 279, 292-296, 299-303,
308, 310-312, 316, 319-320, 323-329, 331-332, 341, 346-347, 354, 359/rev and
360-361 were accepted in full, in part or in principle by the Commission and
incorporated in full, in part or in principle in the Council's position.

3.2.2.
Parliamentary amendments rejected by the
Commission but incorporated in full, in part or in principle in the common
position

Amendments 2, 3, 17, 20, 52, 54, 69, 71,
126, 156 and 349 were rejected by the Commission but incorporated in the
Council's position in full, in part or in principle. These amendments mainly
concern reduced time limits for the inclusion and renewal of inclusion of
candidates for substitution as well as other active substances and shorter
deadlines for certain tasks to be carried out by the European Chemicals Agency
(further 'the Agency'). While the Commission rejected them on grounds that they
would increase the administrative and regulatory burden by adding to the
workload of the Agency, Member States and economic operators without clear
benefits in terms of improved levels of protection, the Council considered them
acceptable.

3.2.3.
Parliamentary amendments accepted in full, in
part or in principle by the Commission but not incorporated in the common
position

Amendments 11, 16, 24, 36, 48, 58-59, 62,
65-66, 72-74, 77-78, 99, 101, 106, 118, 120-121, 157, 162, 166, 175, 178, 191,
193, 196, 200, 203-204, 221-223, 236, 332, 358 and 361 were accepted in full,
in part or in principle by the Commission but not incorporated in the Council's
position. The most common reasons for the rejection of the amendments by the
Council are inconsistency with other changes introduced by the Council, placing
of undue administrative burden on industry, competent authorities or the Agency
and no clear added value of the amendments.

3.2.4.
Parliamentary amendments rejected by the
Commission and the Council and not incorporated in the common position

Amendments 12, 14-15, 19, 26, 28, 40-42,
45-47, 50-51, 57, 64, 81, 84, 92, 97-98, 100, 102-105, 107-111, 117, 119, 122,
127-136, 138, 140-141, 145-147, 150, 158-159, 163-164, 173-174, 176, 182, 188,
192, 195, 197-198, 201, 205, 216-217, 224, 233, 237-238, 240, 246, 250-253,
258-259, 262-265, 270-271, 274, 280-288, 291, 297, 306-307, 309, 318, 321-322, 330,
342-343, 350 and 353 were rejected by both the Commission and the Council.

3.2.5.
Changes made by the Council to the Proposal

The Council proposed the following main
changes to the Commission proposal:

Inclusion of active substances: the Council has changed the procedure for the approval of
inclusions of active substances. The list of approved active substances would
not be included as an Annex to the Regulation but would be established as a
free standing measure through implementing measures and regularly updated. The
Commission considers that the approval of active substances should be undertaken
by using an Annex to the Regulation. Consequently, any additions or amendments
to the annex listing approved active substances would constitute changes to
non-essential elements of the Regulation and would be adopted through delegated
acts based on Article 290 TFEU. However, in order to allow the legislative
procedure to continue, it will not oppose the changes introduced by the
Council. The Commission has made a declaration on this matter at the time of
the political agreement (see Annex 1).

Simplified authorisation procedure: the Council replaced the concept of 'low-risk biocidal products'
with products subject to a simplified authorisation procedure. The criteria
proposed for these products would be more focused on the properties of the
substances contained in the product rather than on a case by case risk
assessment of the product itself as was the case in the Commission's proposal.
These products would no longer be subject to a Union level authorisation
procedure as foreseen in the Commission's proposal but would instead be
submitted for authorisation in one Member State. Once an authorisation is
granted in one Member State, the product could then, subject to the submission
of a notification, be marketed in each of the other Member States. The
Commission considers that the Council's approach will encourage the development
and marketing of biocidal products that present a lower risk to man and the
environment and can therefore accept the Council's position on this issue.

The scope of the Union authorisation: According to the Council's position, the Union authorisation would,
as of 2013, be open for biocidal products falling within product types 6, 7, 9,
10, 12, 13 and 22 and, as of 2020, for biocidal products falling within product
types 14, 15, 17, 21 and 23, provided that the products concerned have similar
conditions of use across the Union. At the latest by 2017, the Commission would
carry out a review and accompany it, if appropriate, with legislative
proposals; e.g. to postpone the opening of the Union authorisation for some or
all product types listed. While the Commission initially proposed a Union
authorisation system with much more limited scope, it can, in principle, accept
the Council's position provided the extension is implemented gradually and that
adequate resources are provided to the Agency and the Commission. The
Commission has made a declaration underlining the resource implications and
calling on the Member States to take the consequent steps to ensure the
provision of adequate resources under the new financial perspectives (see Annex
2).

Treated articles: In line with the approach taken by the European Parliament, the
Council introduced the 'primary biocidal function' as the criterion for
differentiating between biocidal products and treated articles. Furthermore, it
shifted the focus of control from biocidal products to active substances. The
Council decided to impose stricter requirements for treated articles where the
active substances are intended to be released ('external effect') than for
treated articles where the active substances are not intended to be released
('internal effect'). Further rules may be adopted by the Commission, including the
possibility of a notification scheme. The Commission can support these changes
concerning treated articles as they are in line with the objectives of the
Regulation.

Nature and composition of the Biocidal
Products Committee: the Commission initially proposed
the Committee to be composed of independent scientific experts who would be
nominated by the Member States but appointed by the Management Board of the
Agency. The Council opted for an approach according to which the members of the
Committee would be directly appointed by the Member States and there would be
close links between the Committee and Member States' competent authorities.
Given that the responsibility for the detailed implementation of the Regulation
will fall on the competent authorities in the Member States it is coherent that
these same authorities should be closely involved in the work of the Biocidal
Products Committee. The Commission can, therefore, accept the Council's
position.

Fees: the
Commission initially proposed a system whereby the fee for a Union
authorisation would be paid to the Agency which would then reimburse the Member
State for the work as an evaluating competent authority. The Council's position
is based on a system where for the procedures carried out at the Union level,
one fee is paid to the Agency for its work and another is paid to the competent
authority which carries out the role of the evaluating competent authority.
This is acceptable to the Commission. Further, the Commission's proposal
foresaw that the amount of fees payable to the Agency as well as the harmonised
structure (including issues such as reimbursements, reductions/waiving) of fees
applicable to both the Agency and the Member States would be adopted by means
of delegated acts. However, the Council's position foresees that the level of
fees payable to the Agency and the rules defining conditions of payment and
possible reductions should be adopted by means of implementing acts. With
regard to the establishment of a harmonised structure of fees for the Agency
and the Member States, Council has provided that the Commission may address
these questions through guidance documents. Whilst the Commission regrets the
approach taken by the Council, it can accept it in order to allow for the
legislative procedure to continue. The Commission made a declaration set out in
Annex 1 with respect to the Council's position on the use of delegated acts for
setting the fees payable to the Agency.

To take account of the resource
implications resulting from the changes introduced by the Council and the
Parliament in the first reading, including the need to adjust the fee system as
a way to reduce the impact on the Union budget, the Commission has prepared a
revised financial statement which is attached as Annex 3 to this Communication.

4.
Conclusion

The changes introduced by the Council are
acceptable to the Commission as they are consistent with the objectives of the
Commission's proposal and further build upon it. Therefore the Commission can
accept the Council's position.

The Commission already outlined its
concerns over the increased resource implications resulting for the Agency and
the Commission in the declaration set out in Annex 2. In light of the
additional tasks allocated to the Agency and the time needed to prepare all aspects
of its future work as well as the fact that the legislative process is taking
longer than initially anticipated, the Commission considers it necessary to
postpone the date of applicability of the proposed Regulation to 1 September
2013 with the exception of provisions which allow the Commission and the Agency
to take preparatory steps (e.g. delegated/implementing acts,guidance documents).

Annex 1
Declaration on comitology

In a spirit of compromise, the Commission
will not stand against a qualified majority vote in favour of the Presidency
text. However, the Commission would underline that it does not share the views
of the Council that the measures for the approval of active substances (Article
8a) and for rules on fees payable to the European Chemicals Agency (Article
70(1)) are of an implementing nature and thus fall under Article 291 TFEU. As
regards both these matters, the Commission is of the view Article 290 is the
appropriate procedure given that they entail measures of general application which
would modify or supplement the non-essential elements of the Regulation.

Annex 2
Declaration on resource implications

The extension of the scope of the Union
authorisation together with additional tasks allocated to the European
Chemicals Agency, the shorter deadlines and the increased frequency of renewals
for active substances will necessarily result in a significant increase in the
workload of the Agency and the Commission. At the same time, the workload for
national authorities will accordingly be reduced as a result of a wider scope
of Union authorisation. In light of the increased workload, the Agency and the
Commission will need additional financial and human resources to ensure
effective implementation of the Regulation. In view of this, the Commission
calls on the Council to address these requirements under the new financial
perspectives. The Commission is prepared to work with the Council on a suitable
solution.

Annex 3
LEGISLATIVE FINANCIAL STATEMENT FOR PROPOSALS

1.           FRAMEWORK OF THE PROPOSAL/INITIATIVE

1.1.    Title of the proposal/initiative

1.2.    Policy
area(s) concerned in the ABM/ABB structure

1.3.    Nature
of the proposal/initiative

1.4.    Objective(s)

1.5.    Grounds
for the proposal/initiative

1.6.    Duration
and financial impact

1.7.    Management
method(s) envisaged

2.           MANAGEMENT MEASURES

2.1.    Monitoring
and reporting rules

2.2.    Management
and control system

2.3.    Measures
to prevent fraud and irregularities

3.           ESTIMATED FINANCIAL IMPACT OF THE
PROPOSAL/INITIATIVE

3.1.    Heading(s)
of the multiannual financial framework and expenditure budget line(s) affected

3.2.    Estimated
impact on expenditure

3.2.1. Summary of estimated impact on expenditure

3.2.2. Estimated
impact on operational appropriations

3.2.3. Estimated
impact on appropriations of an administrative nature

3.2.4. Compatibility
with the current multiannual financial framework

3.2.5. Third-party
participation in financing

3.3.    Estimated impact on revenue

LEGISLATIVE FINANCIAL STATEMENT FOR PROPOSALS

1.           FRAMEWORK OF THE PROPOSAL/INITIATIVE

1.1.        Title of the
proposal/initiative

Proposal for a regulation of the European Parliament and of the
Council concerning the placing on the market and use of biocidal products.

1.2.        Policy area(s) concerned
in the ABM/ABB structure[1]

Policy area: 07 Environment

Activity Code 07 03: Implementation of Union environmental policy
and legislation

1.3.        Nature of the
proposal/initiative

X The proposal/initiative relates to a new action

 ̈ The
proposal/initiative relates to a new action following a pilot
project/preparatory action[2]

 ̈ The
proposal/initiative relates to the extension of an existing action

 ̈ The
proposal/initiative relates to an action redirected towards a new action

1.4.        Objectives

1.4.1.     The Commission's multiannual strategic objective(s) targeted
by the proposal/initiative

Development of New Policy Initiatives (ABB code 07 05) – 2008 AMP        
To prepare and propose environment policies,
measures and initiatives, based on comprehensive and precise data on the state
of the environment and pressures on it, consulting widely with interested
parties, implementing the 6th EC Environment Action Programme. To prepare policy responses that
may be necessary in the light of new evidence of threats to the environment, or
to human health from the environment.

1.4.2.     Specific objective(s) and ABM/ABB activity(ies) concerned

Specific objective No.1c

To develop new policy initiatives to contribute to the objectives of
the 6th EAP priority area of environment and health. Contribute to a high level
of quality of life and social well being for citizens by providing an
environment where the level of pollution does not give rise to harmful effects
on human health and the environment and by encouraging a sustainable urban
development.

ABM/ABB activity(ies) concerned ABB code
07 05

1.4.3.     Expected result(s) and
impact

Specify the effects
which the proposal/initiative should have on the beneficiaries/groups targeted.

The objectives of the proposal are to ensure a high level of
protection of public health and the environment as well as the harmonisation of
the internal market for biocidal products, while enhancing competitiveness and
innovation.         
To achieve these objectives it is necessary that the hazards and risks from
active substances and biocidal products are fully known before they are placed
on the market.
To ensure the efficient implementation of the proposal it is appropriate to
rely on the existing European Chemicals Agency, which will receive and deliver
opinions on data submitted by industry, for example, for the evaluation of
active substances or certain biocidal products, and will be the focal point for
providing scientific advice and assistance to the Commission, to Member State
competent authorities, to enterprises, especially SMEs, and for making relevant
information available to the public.

The harmonisation of the internal market for biocidal products and
the enhancement of competitiveness and innovation will be strengthened by
having a coherent approach to the treatment of applications submitted by
industry, by simplifying procedures for the authorisation of products, and by
encouraging the development of ‘new’ substances and products having a better
public health or environmental profile, so as to enable the European Union to compete
better with its international competitors, and bring about the greater
availability of substances or products with lower risks.

1.4.4.     Indicators of results and
impact

Specify the
indicators for monitoring implementation of the proposal/initiative.

The objectives and indicators identified to
date are as follows:

Objectives || Indicators for the policy

Assessment of new active substances in view of their approval || Number of opinions delivered. Time from reception of a valid application to transmission of opinion to the Commission.

Renewal of approval of active substances || Number of opinions delivered. Time from reception of a valid application to transmission of opinion to the Commission.

Establishment of technical equivalence between active substances || Number of opinions delivered. Time from reception of a valid application to transmission of opinion to the Commission.

Authorisations of products || Number of opinions delivered. Time from reception of a valid application to transmission of opinion to the Commission.

Opinion in case of disagreement during mutual recognition procedures || Number of opinions delivered. Time from reception of a Commission request to transmission of opinion to the Commission.

Tasks related to data sharing and confidentiality || Number of searches in the database. Number of request for information for non-confidential data.

Development of general and specific guidance documents || Number of guidance documents developed.

Maintenance of Union register on biocidal products || Number of searches in the database

Completion of the review programme of existing substances || Number of opinions delivered. Time from reception of a draft Competent authority report to finalisation of Competent authority report.

1.5.        Grounds for the
proposal/initiative

1.5.1.     Requirement(s) to be met in
the short or long term

Before any active substance can be authorised for use in a biocidal
product, it must be assessed whether its use poses any unacceptable risk for
the environment or public health. This assessment is done by Member State
competent authorities followed by a peer review organised at the Union level,
before a decision is taken by the Commission.

In addition, to improve the authorisation process of biocidal
products, it is proposed that certain products will be authorised directly at
the Union level at the choice of the applicant. Other categories of biocidal
products will continue being authorised at Member State level.

Also, for biocidal products to be authorised by the Member States,
through the mutual recognition procedure, divergence of opinions between Member
States will need to be addressed through an ad hoc conflict resolution
procedure. Most of these divergences of opinions are expected to be of a
scientific or a technical nature.

Processes aimed at facilitating data sharing between prospective
applicants, at establishing technical equivalence of substances manufactured
from different sources, at disseminating information, at identifying active
substance manufacturers entitled to place their active substance on the Union
market will also have to be improved and or developed.

Last, genuine scientific and technical support, including the
development and maintenance of IT tools, for the implementation of the
Regulation will need to be provided.

All these tasks are described in further details in Appendix II.

1.5.2.     Added value of EU involvement

Until today the Commission Joint Research Centre provides a
significant input to the review programme of existing active substances[3].
However, with the downsizing of its activities in the field of chemical
substances due to the transfer of many of these activities to ECHA, the
Commission JRC already announced that it would also stop its activities in the
field of biocidal products at the end of 2013 and would then concentrate on
other priorities.

As the Commission services will then no longer have the expertise
and resources to address issues of scientific or technical nature linked to the
evaluation of active substances and the authorisation of biocidal products, it
was considered most appropriate to seek advice and support from an external
body.

Relying on an external body to carry out the risk assessment is also
in line with the approach adopted in other sectors such as medicinal products,
plant protection products, food, where there is a clear
separation between risk assessment (carried out by scientific bodies) and risk
management (carried out by the Commission).

Having excluded the possibility of establishing a specific body to
be in charge of the risk assessment of active substances and biocidal products,
three existing bodies were considered as possible candidates to provide this
scientific and technical support in the field of biocides:

- The European Agency for the Evaluation of Medicinal Products
(EMEA), because the proposal to authorise certain biocidal products at the Union
level is modelled upon the lines and principles of what already exist since
1995 for medicinal products for veterinary and human use;

- The European Food Safety Authority (EFSA), because Directive
98/8/EC is often referred to as the sister Directive of Directive 91/414/EEC
regulating the placing on the market of plant protection products and where
EFSA is the official scientific body in charge of preparing opinions for the
Commission; and

- The European Chemicals Agency (ECHA).

Limited synergies can however be expected from the first two
options. On the other hand, the choice of ECHA is expected to create
significant synergies, on the basis of the following considerations:

- First and foremost, the evaluation of active substances used in
biocidal products follows many of the methodologies and principles that also
apply to chemical substances regulated under the REACH Regulation. Data
requirements are similar and the risk assessment of these substances, notably
when they have certain hazardous properties, is even of the direct competence
of ECHA.

- In addition, the proposal includes rules concerning data sharing
for biocidal products, which have now been aligned on those of REACH and makes
the sharing of data involving testing on vertebrate animals mandatory. Only
REACH and ECHA have already set up the mechanisms and the databases to make
such sharing possible.

- Another important element of choice is that many of the ECHA
scientific staff is already familiar with biocidal products, through previous
work at the Commission JRC, in Member States Competent Authorities as well as
in industry.

- Last but not least, producers, downstream users of biocidal
products and even the Commission already have a number of obligations under
REACH. Notably, the data held by the Commission JRC relating to active
substances under evaluation in the review programme shall be made available to
ECHA, in accordance with the provision of Article 16 of the REACH Regulation.

For these reasons, it is felt that the ECHA, amongst the other
options at hand - a new agency, the Commission JRC, the EMEA or EFSA - is the
most effective one in terms of possible synergies .

In addition, with the phasing out of the Commission JRC support
concerning the review programme of existing active substances announced for the
end of 2013, ECHA is expected to take over that role from 2014 onwards.

The legislative proposal therefore relies on the assumption that a
number of tasks of a scientific and technical nature related to the assessment
of active substances used in biocidal products and of certain biocidal products
will be given to ECHA.

To this end, financial resources are needed to ensure that ECHA has
the appropriate level of staff and is able to convene as many meetings as
necessary to deliver its opinions to the Commission.

1.5.3.     Lessons learned from
similar experiences in the past

The proposal is based on the conclusions of a study carried out in
2007 to analyse the deficiencies of the current Directive. The results of this
study (available at http://ec.europa.eu/environment/biocides/study.htm)
were incorporated in the Commission report on the impacts of the implementation
of Directive 98/8/EC (available at http://ec.europa.eu/environment/biocides/impl_report.htm).

The Impact Assessment carried out by the Commission addresses five
policy issues that require action: the extension of the scope of the Regulation
to include articles and materials treated with biocidal products; the
improvement of procedures for product authorisation with the possibility to
authorise certain products at the Union level; the introduction of mandatory
data-sharing at product authorisation and active substance approval stage along
the principles of the REACH Regulation; a clarification on data requirements
with a combination of data waiving with the use of existing information and a
new approach for low-risk biocidal products; a partial harmonisation of fee
structure to encourage the development of more new active substances and the
retention of more existing active substances.

1.5.4.     Coherence and possible
synergy with other relevant instruments

See 1.5.2.

1.6.        Duration and financial
impact

 ̈ Proposal/initiative of limited
duration

–
 ̈  Proposal/initiative in effect from [DD/MM]YYYY to [DD/MM]YYYY

–
 ̈  Financial impact from YYYY to YYYY

X Proposal/initiative of unlimited
duration[4]

1.7.        Management mode(s) envisaged[5]

X Centralised direct management
by the Commission

X Centralised indirect management
with the delegation of implementation tasks to:

–
 ̈  executive agencies

–
X  bodies set up by the Communities[6]

–
 ̈  national public-sector bodies/bodies with public-service mission

–
 ̈  persons entrusted with the implementation of specific actions
pursuant to Title V of the Treaty on European Union and identified in the
relevant basic act within the meaning of Article 49 of the Financial Regulation

 ̈ Shared management with the Member States

 ̈ Decentralised management with third countries

 ̈ Joint management with international organisations (to be specified)

If more than one
management mode is indicated, please provide details in the "Comments"
section.

Comments

The overall
responsibility for the implementation and enforcement of the proposed
legislation will rest with the Commission services. However, the scientific and
technical support will be provided by the European Chemicals Agency. ECHA will
in particular have to provide opinions on the level of risk presented by active
substances used in biocidal products as well as on the authorisations of
certain biocidal products. ECHA will provide opinions on the basis of which the
Commission will take decisions.

2.           MANAGEMENT MEASURES

2.1.        Monitoring and reporting
rules

Specify frequency
and conditions.

In order to evaluate the progress of implementation and effects of
the new policy, the indicators as set out in 1.4.4 will be gathered and monitored
at regular intervals. For the most part, this will be done as part of the
normal activity of ECHA on an annual basis.

In addition to this, Member States shall
submit to the Commission every three years a report on enforcement and control
measures and results of these measures. The Commission
shall also draw up a report on the implementation of the Regulation and in
particular on the functioning of the Union authorisation procedure and on the implementation
of the provisions concerning treated articles.

2.2.        Management and control
system

2.2.1.     Risk(s) identified

As the Council text would significantly increase
the workload for ECHA and the Commission, increased resources would need to be
provided to cover the additional tasks to be carried out.

Increased resources are provided through this
revised financial statement. However, it will need to be monitored over time
whether these resources correspond correctly with these additional tasks.

2.2.2.     Control method(s) envisaged

As indicated in Section 2.1, ECHA will report
annually on the progress of implementation and on the
effects of the new policy. Member States will also report every three years on enforcement and control measures. This information will be used by the
Commission in order to prepare the report on the implementation of the
Regulation.

Also, in view of the number of assumptions and the degree of
uncertainties with the different calculations underlying this financial
statement, ECHA staff levels will have to be reviewed on an annual basis taking
into account the real volume of activities.

2.3.        Measures to prevent fraud
and irregularities

Specify existing or
envisaged prevention and protection measures.

The European Chemicals Agency has specific budgetary control
mechanisms and procedures which are based on Regulation (EC, Euratom) No
2343/2002.

The Management Board of ECHA, which comprises representatives of the
Member States, the Commission and the European Parliament (Article 79(1) of the
REACH Regulation), produces an estimate of the revenue and expenditure of ECHA
(Article 96(5)) and adopts the final budget (Article 96(9)). Each year, the
provisional and final accounts are sent to the European Court of Auditors (paragraphs
4 and 7 of Article 97). The European Parliament gives a discharge to the Executive
Director of ECHA regarding the implementation of the budget (Article 97(10)).

In order to combat fraud, corruption and other unlawful activities,
the provisions of Regulation (EC) No 1073/1999 concerning
investigations conducted by the European Anti-Fraud Office (OLAF) apply without
restrictions to ECHA, in accordance with Article 98(1) of Regulation (EC) No
1907/2006.

In accordance with Article 98(2), ECHA is also bound by the Inter-institutional
Agreement of May 25, 1999 concerning internal investigations by the
European Anti-Fraud Office (OLAF).

3.           ESTIMATED FINANCIAL IMPACT OF THE
PROPOSAL/INITIATIVE

3.1.        Heading(s) of the
multiannual financial framework and expenditure budget line(s) affected

· Existing expenditure budget lines

Heading of multiannual financial framework || Budget line || Type of expenditure || Contribution

Number [Description........................................] || Diff./non-diff ([7]) || from EFTA[8] countries || from candidate countries[9] || from third countries || within the meaning of Article 18(1)(aa) of the Financial Regulation

2 || 07 03 60 01 European Chemicals Agency - Activities in the field of biocides legislation - Contribution to Titles 1 and 2 from Heading 2 || Diff. || YES || NO || NO || NO

2 || 07 03 60 02 European Chemicals Agency -Activities in the field of biocides legislation - Contribution to Title 3 from Heading 2 || Diff. || YES || NO || NO || NO

These budget lines will cover ECHA’s staff
and administrative expenditure (titles 1 and 2) and ECHA's operating
expenditure (title 3) for the activities to be carried out in the field of
biocidal products in accordance with this Regulation, as part of the annual
subsidy to the European Chemicals Agency (ECHA) from the Union budget (in
addition to any appropriations granted under budget items 02 03 03 01 and 02 03
03 02 to finance the activities of the REACH Regulation (EC) No 1907/2006 and
CLP Regulation (EC) No 1272/2008).

· No new budget lines are requested

3.2.        Estimated impact on
expenditure

3.2.1.     Summary of estimated impact
on expenditure

EUR million (to 3 decimal places)

Heading of multiannual financial framework: || 2 || Conservation and management of natural resources (including market expenditure and direct payments)

DG: ENV || || || 2012[10] || 2013 || Estimates of the operational appropriations are limited to the current financial programming running until 2013. || TOTAL

Ÿ Operational appropriations || || || ||

Number of budget line: 07 03 60 01 || Commitments || (1) || 1,507 || 4,050 || 5,557

Payments || (2) || 1,507 || 4,050 || 5,557

Number of budget line: 07 03 60 02 || Commitments || (1a) || 1,249 || 2,302 || 3,551

Payments || (2a) || 1,249 || 2,302 || 3,551

Appropriations of an administrative nature financed from the envelope for specific programmes[11] || || ||

Number of budget line || || (3) || || ||

TOTAL appropriations for DG ENV || Commitments || =1+1a +3 || 2,756 || 6,352 || 9,108

Payments || =2+2a +3 || 2,756 || 6,352 || 9,108

Ÿ TOTAL operational appropriations || Commitments || (4) || 2,756 || 6,352 || || || || 9,108

Payments || (5) || 2,756 || 6,352 || || || || 9,108

Ÿ TOTAL appropriations of an administrative nature financed from the envelope for specific programmes || (6) || || || || || ||

TOTAL appropriations under HEADING 2 of the multiannual financial framework || Commitments || =4+ 6 || 2,756 || 6,352 || || || || 9,108

Payments || =5+ 6 || 2,756 || 6,352 || || || || 9,108

Heading of multiannual financial framework: || 5 || Administrative expenditure

EUR million (to 3 decimal places)

|| || || 2012 || 2013 || Estimates of the administrative appropriations are limited to the current financial programming running until 2013. || TOTAL

DG: ENV ||

Ÿ Human resources || || || ||

Ÿ Other administrative expenditure || 0,204 || 0,204 || 0,408

TOTAL DG ENV || Appropriations || 0,204 || 0,204 || 0,408

TOTAL appropriations under HEADING 5 of the multiannual financial framework || (Total commitments = Total payments) || 0,204 || 0,204 || || 0,408

EUR million (to 3 decimal places)

|| || || 2012 || 2013 || Estimates of the total appropriations are limited to the current financial programming running until 2013. || TOTAL

TOTAL appropriations under HEADINGS 1 to 5 of the multiannual financial framework || Commitments || 2,960 || 6,556 || || 9,516

Payments || 2,960 || 6,556 || 9,516

3.2.2.     Estimated impact on
operational appropriations

–
 ̈  The proposal/initiative does not require the use of operational
appropriations

–
X  The proposal/initiative requires the use of
operational appropriations, as explained below:

Commitment appropriations in EUR million (to 3 decimal
places)

Indicate objectives and outputs ò || || || 2012 || 2013 || Estimates of the operational appropriations are limited to the current financial programming running until 2013. || TOTAL

OUTPUTS

Type of output[12] || Average cost of the output || Number of outputs || Cost || Number of outputs || Cost || Number of outputs || Cost || Number of outputs || Cost || Number of outputs || Cost || Number of outputs || Cost || Number of outputs || Cost || Total number of outputs || Total cost

SPECIFIC OBJECTIVE No 1: ECHA scientific and technical support || Please refer to Appendix 1 for a detailed breakdown of ECHA’s costs and to Appendix 2 for the main underlying assumptions.

TOTAL COST || || 2,756 || || 6,352 || || || || || || || || || || || || 9,108

3.2.3.     Estimated impact on
appropriations of an administrative nature

3.2.3.1.  Summary

–
 ̈  The proposal/initiative does not require the use of administrative
appropriations

–
X  The proposal/initiative requires the use of
administrative appropriations, as explained below:

EUR million (to 3
decimal places)

|| 2012 || 2013 || Estimates of the administrative appropriations are limited to the current financial programming running until 2013. || TOTAL

HEADING 5 of the multiannual financial framework || || || ||

Human resources || || || ||

07 01 02 11 01 – Missions || 0,024[13] || 0,024 || ||

07 01 02 11 03 – Committees || 0,180[14] || 0,180 || ||

Other administrative expenditure || || || ||

Subtotal HEADING 5 of the multiannual financial framework || 0,204 || 0,204 || || 0,408

Additional resources will be required to
cover participation in meetings held in ECHA and for the organisation of an
increased number of meetings of the Standing Committee on Biocidal Products.

TOTAL || 0,204 || 0,204 || || 0,408

3.2.3.2.  Estimated requirements of
human resources

–
 ̈  The proposal/initiative does not require the use of human
resources

–
X  The proposal/initiative requires the use of
human resources, as explained below:

Estimate to be expressed in full amounts
(or at most to one decimal place)

|| || 2012 || 2013 || Estimates of human resources are limited to the current financial programming running until 2013

Ÿ Establishment plan posts (officials and temporary agents) ||

|| 07 01 01 01 (Headquarters and Commission’s Representation Offices) || 0 || 3 ||

|| XX 01 01 02 (Delegations) || || ||

|| XX 01 05 01 (Indirect research) || || ||

|| 10 01 05 01 (Direct research) || || ||

|| Ÿ External personnel (in Full Time Equivalent unit: FTE)[15] ||

|| XX 01 02 01 (CA, INT, SNE from the "global envelope") || || ||

|| XX 01 02 02 (CA, INT, JED, LA and SNE in the delegations) || || ||

|| XX 01 04 yy [16] || - at Headquarters[17] || || ||

|| - in delegations || || ||

|| XX 01 05 02 (CA, INT, SNE - Indirect research) || || ||

|| 10 01 05 02 (CA, INT, SNE - Direct research) || || ||

|| Other budget lines (specify) || || ||

|| TOTAL || 0 || 3 ||

No additional staff will be necessary in
2012. Three additional posts will be required in 2013. These posts will be
provided through internal re-deployment. See Appendix IV for a detailed
breakdown.

Description of
tasks to be carried out:

Officials and temporary agents || Additional staff is required to process the opinions received from ECHA and to turn these opinions into Commission decisions through delegated and implementing acts.

External personnel ||

3.2.4.     Compatibility with the
current multiannual financial framework

–
 ̈  Proposal/initiative is compatible the current multiannual
financial framework.

–
X  Proposal/initiative will entail reprogramming
of the relevant heading in the multiannual financial framework.

Explain what reprogramming is required,
specifying the budget lines concerned and the corresponding amounts.

2,960 M€ in 2012 (1,507 M€
for budget line 07 03 60 01 and 1,249 M€ for
budget line 07 03
60 02)

6,556 M€ in 2013 (4,050 M€
for budget line 07 03 60 01 and 2,302 M€ for budget line 07 03 60 02)

–
 ̈  Proposal/initiative requires application of the flexibility
instrument or revision of the multiannual financial framework[18].

3.2.5.     Third-party contributions

–
The proposal/initiative does not provide for
co-financing by third parties.

3.3.        Estimated impact on
revenue

–
X  Proposal/initiative has no financial impact
on revenue.

–
 ̈  Proposal/initiative has the following financial impact:

–
 ̈         on own resources

–
 ̈         on miscellaneous revenue

There is no impact on
the revenue side of the Union budget. ECHA's budget foresees its own revenues
consisting of the fees paid by industry, which ECHA is authorised to collect by
virtue of the tasks entrusted to it under this Regulation and a balancing
subsidy from the Union budget.

The proposal foresees that ECHA would charge fees (see Appendix II),
in particular for the approval and renewal of approval of active substances,
for the evaluation of application for the authorisation, modification of
authorisation and renewal of authorisation of certain biocidal products at the Union
level, as well as an annual fee to be paid by holders of Union authorisations
and a submission fee to be paid by all applicants for a first national
authorisation of a product.

Although the activities relating to approval of active substances
and authorisation of biocidal products are expected to be self-financed after a
few years, a balancing subsidy from the Union budget could still be necessary,
if the fee structure does not cover the expenses.

The present financial fiche has been established with the hypothesis
that some tasks would not be covered by the fees:

–
Preparation of opinions on questions referred to
ECHA by virtue of Article 30 of the proposal, in case of disagreement between
Member States during a mutual recognition procedure

–
Tasks related to data sharing and
confidentiality

–
Development of general and specific guidance
documents

–
Completion of Review Programme for existing
substances

–
Reductions for SMEs (as proposed in point (a) of
Article 70(2))

–
Other tasks of Union interest not covered by
fees

Also, the proposal
requires a clear separation of ECHA's budget between activities to be carried
out in accordance with the provisions of the REACH Regulation and the new and
additional tasks derived from this proposal. As a consequence, expenditures and
revenues under these additional tasks have to be clearly identified by the
accounting system of the Agency.

Appendix I
Draft Budget for the European Chemicals Agency (in Euros)
Tasks related to biocidal products

|| 2012 || 2013 || 2014 || 2015 || 2016 || 2017 || 2018 || 2019 || 2020 || 2021

Expenditure || || || || || || || || || ||

|| || || || || || || || || ||

Title1 || || || || || || || || || ||

Salaries & allowances || 1.014.600 || 4.109.400 || 6.388.100 || 6.568.500 || 6.708.000 || 7.565.300 || 8.168.600 || 9.786.900 || 12.530.100 || 13.774.200

Other personnel costs* || 157.300 || 637.000 || 990.200 || 1.018.100 || 1.039.700 || 1.172.600 || 1.266.100 || 1.517.000 || 1.942.200 || 2.135.000

|| || || || || || || || || ||

Total Title 1 || 1.171.900 || 4.746.400 || 7.378.300 || 7.586.600 || 7.747.700 || 8.737.900 || 9.434.700 || 11.303.900 || 14.472.300 || 15.909.200

|| || || || || || || || || ||

Title 2* || || || || || || || || || ||

20 Rental of building and associated costs || 173.600 || 703.100 || 1.093.000 || 1.123.900 || 1.147.800 || 1.294.500 || 1.397.700 || 1.674.600 || 2.144.000 || 2.356.800

21 Information & communication technology || 115.100 || 466.100 || 724.500 || 745.000 || 760.800 || 858.100 || 926.500 || 1.110.000 || 1.421.200 || 1.562.300

22 Movable property and associated costs || 24.000 || 97.300 || 151.300 || 155.500 || 158.800 || 179.100 || 193.400 || 231.700 || 296.700 || 326.100

23 Current administrative expenditure || 21.900 || 88.800 || 138.100 || 142.000 || 145.000 || 163.500 || 176.600 || 211.500 || 270.800 || 297.700

25 Meetings expenditure || 400 || 1.700 || 2.700 || 2.800 || 2.800 || 3.200 || 3.500 || 4.100 || 5.300 || 5.800

|| || || || || || || || || ||

Total Title 2 || 335.000 || 1.357.000 || 2.109.600 || 2.169.200 || 2.215.200 || 2.498.400 || 2.697.700 || 3.231.900 || 4.138.000 || 4.548.700

|| || || || || || || || || ||

Title 3* || || || || || || || || || ||

3003-3006 Substances, products and technical equivalence || 7.400 || 15.900 || 24.200 || 24.700 || 25.300 || 28.200 || 30.600 || 35.300 || 45.100 || 49.800

3007 Assistance and guidance through helpdesk || 50.000 || 59.500 || 90.800 || 92.400 || 94.600 || 105.400 || 114.500 || 132.200 || 169.000 || 186.500

3008 Scientific IT tools** || 1.000.000 || 1.700.000 || 400.000 || 400.000 || 400.000 || 400.000 || 400.000 || 400.000 || 400.000 || 400.000

3009 Scientific and technical advice to EU institutions and bodies || 8.300 || 17.900 || 27.300 || 27.800 || 28.400 || 31.700 || 34.400 || 39.700 || 50.800 || 56.000

3011 Biocidal product committee || 0 || 1.131.200 || 1.171.200 || 1.086.900 || 1.197.800 || 1.235.800 || 1.287.000 || 1.345.000 || 1.302.800 || 1.480.600

3011 Fees paid to rapporteurs || 0 || 56.000 || 111.000 || 271.000 || 275.000 || 444.800 || 452.600 || 474.000 || 874.000 || 880.000

3012 Board of appeal || 0 || 22.400 || 34.200 || 34.900 || 35.700 || 39.800 || 43.200 || 49.900 || 63.800 || 70.300

3013 Communication including translations || 100.000 || 300.000 || 200.000 || 200.000 || 200.000 || 200.000 || 200.000 || 200.000 || 200.000 || 200.000

3022 Management Board and management of the Agency || 44.300 || 95.500 || 145.600 || 148.300 || 151.800 || 169.200 || 183.700 || 212.100 || 271.200 || 299.200

3030 Missions || 25.000 || 25.800 || 39.300 || 40.000 || 41.000 || 45.700 || 49.600 || 57.200 || 73.200 || 80.800

3031 External training || 3.700 || 8.000 || 12.300 || 12.500 || 12.800 || 14.200 || 15.500 || 17.900 || 22.800 || 25.200

38 International activities || 10.900 || 46.900 || 71.500 || 72.800 || 74.500 || 83.000 || 90.200 || 104.100 || 133.100 || 146.900

|| || || || || || || || || ||

Total Title 3 || 1.249.600 || 3.479.100 || 2.327.400 || 2.411.300 || 2.536.900 || 2.797.800 || 2.901.300 || 3.067.400 || 3.605.800 || 3.875.300

|| || || || || || || || || ||

Total || 2.756.500 || 9.582.500 || 11.815.300 || 12.167.100 || 12.499.800 || 14.034.100 || 15.033.700 || 17.603.200 || 22.216.100 || 24.333.200

|| || || || || || || || || ||

Revenues || || || || || || || || || ||

|| || || || || || || || || ||

Union subvention || 2.756.500 || 6.351.800 || 4.936.800 || 3.151.800 || 3.053.000 || 1.842.200 || 1.974.600 || 2.954.300 || -322.800 || -1.386.400

Fee income of agency || 0 || 3.230.700 || 6.878.500 || 9.015.300 || 9.446.800 || 12.191.900 || 13.059.100 || 14.648.900 || 22.538.900 || 25.719.600

Over income to next year || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0 || 0

|| || || || || || || || || ||

Total || 2.756.500 || 9.582.500 || 11.815.300 || 12.167.100 || 12.499.800 || 14.034.100 || 15.033.700 || 17.603.200 || 22.216.100 || 24.333.200

*Relative to staff costs (based on ECHA 2011budget)

**Between 2014 and 2021, annual maintenance costs fixed
at 20% of the initial development costs

Appendix        II
Applied methodology and main underlying assumptions for the financial model of
the European Chemicals Agency for activities relating to biocides

At the time of the
political agreement, the Commission made a statement pointing out that the
Council text would significantly increase the workload for ECHA and the
Commission and that increased resources would need to be provided to cover the
additional tasks to be carried out.

Concerning the role of ECHA, the Council's
political agreement has introduced some important changes as compared to the
Commission's initial proposal:

· the scope of the EU centralised procedure for product authorisation
has been widened significantly which will mean that the Agency – but also the
Commission - will have to process considerably more applications than initially
foreseen;

· ECHA will have a greater involvement in data sharing in order to
avoid duplicate testing on vertebrates and will also be called upon to take
decisions regarding the "technical equivalence" of similar active
substances;

· ECHA is now explicitly identified as providing the secretariat for
the co-ordinating group overseeing mutual recognition;

· ECHA will be responsible for maintenance of the Register for
Biocidal Product which will also include information important in view of data
sharing;

· Finally, ECHA will only receive the fees necessary for its work
including the functioning of the Biocidal Product Committee. Member States will
charge their own fees directly including when they are acting as an evaluating
Member State for an application at EU Level.

This revised financial fiche takes account of the additional workload both for ECHA and for
the Commission.

This revised financial
fiche also takes into account the revised timing for the adoption of the
Regulation. As the regulation is now expected to be adopted around mid-2012,
the 2012 staff levels and resources have been adjusted accordingly.

19 staff will be needed in 2012 rising rapidly
to 59 in 2013 to eventually reach 110 by 2021(further details are provided in
Appendix III).

The majority of ECHA's additional resource costs
will be covered by the additional revenues derived from fees. However, there
will need to be an EU subsidy for the early years to bridge the gap until the
fee revenues achieve a sufficient level. ECHA will also face significant
investment costs in the IT system necessary to manage the information flow
linking applicants, Agency, Member States, the Commission and the general
public.

While recognizing that
the Union is in a period of severe financial constraints, it is nevertheless
unrealistic to load further tasks on ECHA and the Commission without allocating
the resources necessary to carry out these additional tasks.

Title 1 costs (staff costs)

Due to the fact that the Commission JRC in
Ispra currently has a major role in operating the review programme of active substances
used in biocidal products established by Directive 98/8/EC, significant
experience exists with regard to how long certain tasks take and what kind of
resources are needed in order to carry them out (differentiation between
different categories of staff).

Based on this experience and on the model
developed for the operation of REACH, a staff model has been developed for the
operation of the activities related to biocides. The output of this staff model
is how many staff (by grade) are required in a given year to fulfil the tasks
of ECHA (operational tasks of the biocides legislation).

To these staff numbers additional resource
requirements have been added for the management and training of these
resources, taking into account economies of scale that can be achieved in
particular in support tasks and staff from existing arrangements set up for the
implementation of the REACH Regulation (e.g. for international relations, for
external communication, helpdesk services, the Legal Department, Audit and
Internal Control, Human Resources (HR), Finance, Information Technology (IT)
Building Management). Based on the current ECHA staff ratio, these additional
resources amount to 30% of those required for the operational tasks related to
the biocidal legislation.

For the scientific staff, the ratio in % of
AD and AST grades is in compliance with the REACH staff model. As is the case
for staff carrying out REACH related tasks, a higher number of AD than AST
staff is justified because of the complexity of the scientific tasks.

For 2012, it is proposed that ECHA should
be able to recruit staff to prepare the ground before the date when ECHA tasks
relating to biocidal products come into operation.

From 2013, ECHA would then be responsible
for the different tasks set out in the proposal.

From 2014, the responsibility of
coordinating the review programme of existing substances would be transferred from
the Commission JRC to ECHA. ECHA would therefore need extra resources to carry
out this additional task. Based on the current assumptions, ECHA would require 5
additional scientific officers to carry that task (who could already be
recruited in second semester of 2013 to prepare the activities and ensure a
smooth hand-over). It has also been taken into account that, based on the
current pace of less than 30 dossiers being finalised every year by Member
States, the Review Programme would last until 2024, assuming that the pace of
evaluation would speed up to 50 dossiers being finalised every year as certain
dossiers could be grouped for substances supported in several product-types.

Appendix III sets out the proposed
establishment plan related to this proposal. The budget set out in Appendix I
takes into account permanent / temporary staff (i.e. that appears in
establishment plan) and contract agents (count for staff costs but do not
appear in establishment plan).

All the resources
computed have been multiplied by the average annual cost by grade and that has
led to the total staff costs. In addition, the weighting factor for Helsinki (121.3%
– cost of living adjustment applicable to all staff) and an annual indexation
of 2% have been applied.

The
other personnel costs in Title 1 have been assumed to represent 15.5% of salary
costs of permanent / temporary staff - based on the current ratio between Articles 110, 111,
119 and the other Articles of Title 1 of the 2011 Agency budget.

Applied average
costs for permanent/temporary staff by grade per annum (source ECHA)

Grade || Salary

AD 13 || 243.156

AD 12 || 195.900

AD 5-11 || 120.288

AST 7-11 || 104.778

AST 1-6 || 66.872

Applied average
costs for contract agents by function group per annum (source ECHA)

Grade || Salary

FG IV || 55.632

FG III || 54.648

FG II || 34.992

For the purpose of the computation of the
staff required it has been assumed that per year the following resources would
be needed:

–
a desk officer per 8 applications for product
authorisation;

–
a desk officer per 8 applications for new active
substance evaluation;

–
a desk officer per 20 applications for the
establishment of technical equivalence;

–
a desk officer per 30 applications to amend an
existing product authorisation;

–
a desk officer per 20 opinions requested in case
of disagreement during Mutual Recognition.

Title 2 costs (building, equipment and
miscellaneous operating expenditure)

All building,
equipment, furniture, IT and other administrative expenditure are directly
proportional to the number of required staff and have
been assumed to represent - based on the current ratio between Title 1
and Title 2 of the 2011 Agency budget - 28.6% of the total of Title 1.

Title 3 costs (Operating expenditure)

The major cost driver for the general
operating expenditure is the expenditure for the Committee for Biocidal
Products. The current average cost of a three day meeting of the ECHA Member
State Committee is 70.000 EUR.

For the Committee for Biocidal Products and
its experts groups, the costs include the reimbursement of travel, hotel, daily
allowances according to currently applicable Commission rates.

The number of meeting-days/year of the
Biocidal Products Committee has been set to 17 in 2013. Thereafter the number
of meetings will increase to reflect the proportional increase in the number of
opinions to be delivered.

The costs of sub-groups meetings has also
been taken into account, assuming that there would be 4 sub-groups that would
each meet 7 times a year on average during 2 days with 15 experts present in
2013 and 2014. Thereafter the number of meetings will also increase to reflect
the proportional increase in the number of opinions to be delivered.

There is no coverage for the meetings of
the Coordination Group, as these meetings are planned to be organised in ECHA
back-to-back to the meetings of the Biocidal Products Committee.

Awareness rising to alert companies to
their responsibilities will need to take place in the early years of the coming
into force of the Regulation – a specific campaign will need to be planned and
executed. While the staff needs for this activity is covered by the horizontal
and support staff the work will also require a budget to cover the cost of at
least one event (100.000 EUR); the production and translation (into 22
languages) of Guidance, an IT manual, simple publications explaining the
legislation and its implications (400.000 EUR); webinars for companies (10.000
EUR); advertising and PR support (80.000 EUR); and a benchmarking survey at the
start of the campaign for evaluation purposes (10.000 EUR). The costs of these
activities are covered by the Communication budget for 2012, 2013 and 2014.

Mission costs reflect the many activities
(support to Commission services, IT development, monitoring of the current
review programme, awareness raising) which will require intensive contacts with
the Commission services, Member States competent authorities, industry and
other stakeholders.

The IT costs reflect the future needs. 1
million EUR and 1.7 million EUR will be necessary in respectively 2012 and 2013
due to the complexity of the transactions, number of active users, and new
elements. This would also bring future amounts to a level of 400,000 EUR per
year since maintenance should be calculated as 20% of the initial investment.
This level of maintenance is justified especially as it is not realistic to
assume a stable system after the initial investment without considerable evolving
elements.

It has also been assumed for the purpose of
the computation of ECHA expenses that 12.5% of the fee paid to ECHA would be
paid back to the Rapporteur in charge of coordinating the peer-review of the scientific
evaluation carried out by the evaluating Competent Authority.

Computation of expected fee income:

It is assumed that ECHA will have a very
simple fee structure for tasks related to biocidal products.

For the purpose of the computation of the
expected fee income it has been assumed that:

–
Fees for approval of an active substance amount
to EUR 80,000

–
Fees for renewal of an approval amount to EUR 20,000
when a thorough evaluation is required but can be reduced to 5,000 when this is
not the case.

–
Fees for amendments to product authorisation
range from EUR 5.000 to EUR 20.000 depending on the nature of the amendment and
the extent to which data need to be re-assessed.

–
Fees for the establishment of technical
equivalence amount to EUR 20,000

–
Fees for product authorisation amount to EUR 80,000
but can be increased to 120.000, when there will be a need to perform a
comparative risk assessment.

–
Annual fees amount to EUR 20,000

–
Submission fees for a first national
authorisation of a product amount to EUR 4,000

The specific needs of SMEs will be taken
into account, as appropriate.

The amounts of fees above were calculated to
ensure that the Agency would function on the basis of full-costs recovery and
become self-financed by 2021.

It should be born in mind that a fee will
also be charged by the evaluating Member State. For a product authorisation
issued at Union level, applicants will thus have to pay EUR 80.000 to ECHA and
another fee to the evaluating Member State. If one compares these fees with
what would need to be paid in the case of mutual recognition (an evaluating fee
to the Reference Member State and processing fees to the Concerned Member
State), it is assumed that the fees charged for the centralised procedure will
be of the same order of magnitude as those charged for a Mutual Recognition
procedure involving 18, and possibly less, Member States, as one should also
take into account all the support costs associated with the submission of
applications in different Member States that will be saved for companies opting
for the centralised procedure.

The submission fee, to be paid by all
applicants for a first national authorisation of a product, is intended to
cover the costs of ECHA support to national authorisation and mutual
recognition of these authorisations. ECHA will indeed provide the secretariat
to the coordination group overseeing mutual recognition and an IT platform,
which should be used by applicants for the submission of their applications and
the dissemination of their application to Member States.

One of the other underlying assumptions for
the computation of the expected fee income is the number of products for which
applications for a Union authorisation will be submitted.

The computation is rather complex and
includes several parameters or assumptions:

· the number of products on the market today (20.000);

· the proportion of products to be eventually supported and authorised
in accordance with the proposed Regulation (2/3);

· the application of the new concept of biocidal product family, which
will facilitate the authorisation of very similar products through one
application and decision (it was assumed that biocidal product families would
contain 6 products on average for PT 1 to 5);

· the timing of decisions to be taken regarding the approval of active
substances in the context of the Review programme for existing active
substances;

· the obligation that products containing existing active substances
should be authorised in accordance with the proposed Regulation within two
years of the approval of active substances;

· the product-types included in the scope and the timelines for these
product-types to be eligible for the centralised procedure as proposed by the
Council;

· 30% of companies will opt for the centralised procedure when they
will be in the position to do so.

All this taken
into account, it is expected that the number of applications will raise from 10
in 2014 to 140 in 2021, as indicated in the table below:

|| 2013 || 2014 || 2015 || 2016 || 2017 || 2018 || 2019 || 2020 || 2021

|| || || || || || || || ||

Applications/year || 0 || 10 || 40 || 50 || 70 || 70 || 70 || 140 || 140

Similarly, the number of expected applications
for the establishment of technical equivalence has been set to 50 per year in
the early years of the coming into force of the Regulation, and to 20
afterwards, as one would expect a peak of requests during these years, as
companies will be expected to seek the establishment of the technical
equivalence of their active substance with the one supported under the Review
programme for existing active substances before starting to negotiate data
sharing agreements.

|| 2013 || 2014 || 2015 || 2016 || 2017 || 2018 || 2019 || 2020 || 2021

|| || || || || || || || ||

Applications/year || 50 || 50 || 50 || 20 || 20 || 20 || 20 || 20 || 20

Last but not
least, in view of the number of assumptions and the degree of uncertainties
with the different calculations, the staff levels will have to be reviewed on
an annual basis taking into account the real volume of activities.

As an indication, a revenue increase from
fees of 200.000 EUR would allow a 1 FTE increase to the staff level and a
EUR 40.000-addition to Title 3. Conversely,
if fees do not materialize as expected, then staff and Title 3 costs should be
also adjusted accordingly.

Appendix III
Staff requirements in full time equivalent (FTE)

|| || 2012 || 2013 || 2014 || 2015 || 2016 || 2017 || 2018 || 2019 || 2020 || 2021

|| || || || || || || || || || ||

Completion of review programme || AD ||   || 5,0 || 5,0 || 5,0 || 5,0 || 5,0 || 5,0 || 5,0 || 5,0 || 5,0

|| AST ||   || || 1,3 || 1,3 || 1,3 || 1,3 || 1,3 || 1,3 || 1,3 || 1,3

Approval of new active substances || AD ||   || 0,6 || 0,6 || 0,6 || 0,6 || 0,6 || 0,6 || 0,6 || 0,6 || 0,6

|| AST ||   || 0,2 || 0,2 || 0,2 || 0,2 || 0,2 || 0,2 || 0,2 || 0,2 || 0,2

Renewal of active substance approvals || AD ||   || 0,3 || 0,3 || || || 0,2 || 0,4 || 4,0 || 6,0 || 6,0

|| AST ||   || || || || || || || 1,4 || 2,1 || 2,1

Technical equivalence || AD || 2,0 || 2,5 || 2,5 || 2,5 || 1,0 || 1,0 || 1,0 || 1,0 || 1,0 || 1,0

|| AST ||   || 0,9 || 0,9 || 0,9 || 0,4 || 0,4 || 0,4 || 0,4 || 0,4 || 0,4

Authorisation of biocidal products || AD ||   || 1,0 || 1,3 || 5,0 || 5,0 || 8,8 || 8,8 || 8,8 || 17,5 || 17,5

|| AST ||   || || 0,4 || 1,8 || 1,8 || 3,1 || 3,1 || 3,1 || 6,1 || 6,1

Amendments of Union authorisations || AD ||   || || || 0,2 || 0,8 || 1,5 || 2,7 || 3,8 || 5,0 || 6,0

|| AST ||   || || || 0,1 || 0,3 || 0,5 || 0,9 || 1,3 || 1,8 || 2,1

Mutual Recognition disagreements || AD ||   || 2,0 || 2,0 || 2,0 || 2,0 || 2,0 || 2,0 || 2,0 || 2,0 || 2,0

|| AST ||   || 0,7 || 0,7 || 0,7 || 0,7 || 0,7 || 0,7 || 0,7 || 0,7 || 0,7

Data sharing and confidentiality || AD ||   || 3,0 || 3,0 || 2,0 || 2,0 || 2,0 || 2,0 || 2,0 || 2,0 || 2,0

|| AST ||   || 0,8 || 0,8 || 0,5 || 0,5 || 0,5 || 0,5 || 0,5 || 0,5 || 0,5

Communication and guidance || AD || 5,0 || 8,0 || 5,0 || 5,0 || 5,0 || 5,0 || 5,0 || 5,0 || 5,0 || 5,0

AST ||   || 2,0 || 2,8 || 2,8 || 2,8 || 2,8 || 2,8 || 2,8 || 2,8 || 2,8

Committees and board of appeal || AD || 1,0 || 4,1 || 4,2 || 4,1 || 4,2 || 4,2 || 4,3 || 4,3 || 4,3 || 4,5

|| AST ||   || 0,8 || 0,8 || 0,7 || 0,8 || 0,8 || 0,8 || 0,9 || 0,9 || 0,9

IT development and maintenance || AD || 4,0 || 4,0 || 4,0 || 3,0 || 3,0 || 3,0 || 3,0 || 3,0 || 3,0 || 3,0

AST || 2,0 || 2,0 || 2,0 || 1,0 || 1,0 || 1,0 || 1,0 || 1,0 || 1,0 || 1,0

Support staff || AD || 3,0 || 10,0 || 9,0 || 10,0 || 9,0 || 11,0 || 11,0 || 14,0 || 18,0 || 17,0

|| AST || 1,0 || 2,0 || 3,0 || 2,0 || 3,0 || 4,0 || 4,0 || 6,0 || 7,0 || 7,0

Overall Management || AD || 1,0 || 5,3 || 5,2 || 5,3 || 5,2 || 5,5 || 5,6 || 10,2 || 11,0 || 11,1

|| AST || || 2,0 || 3,0 || 3,0 || 3,0 || 3,0 || 3,0 || 5,0 || 5,0 || 5,0

|| || || || || || || || || || ||

Total staff || AD || 16 || 47 || 43 || 45 || 44 || 50 || 52 || 63 || 81 || 81

|| AST || 3 || 12 || 16 || 14 || 15 || 19 || 20 || 28 || 29 || 29

|| || || || || || || || || || ||

|| TA || 11 || 47 || 50 || 50 || 50 || 60 || 60 || 80 || 100 || 100

|| CA || 8 || 12 || 9 || 9 || 9 || 9 || 12 || 9 || 10 || 10

|| || || || || || || || || || ||

|| Overall || 19 || 59 || 59 || 59 || 59 || 69 || 72 || 87 || 110 || 110

Draft Establishment Plan

2012 || 2013 || 2014 || 2015 || 2016 || 2017 || 2018 || 2019 || 2020 || 2021

|| || || || || || || || ||

11 || 47 || 50 || 50 || 50 || 60 || 60 || 80 || 100 || 100

Appendix IV
Commission resources

The number of opinions to be delivered by the
Agency is expected to rise from 85 in 2013 to more than 400 in 2021 (see table
below).

|| 2012 || 2013 || 2014 || 2015 || 2016 || 2017 || 2018 || 2019 || 2020 || 2021

|| || || || || || || || || ||

Approval of new active substances || || 5 || 5 || 5 || 5 || 5 || 5 || 5 || 5 || 5

Approval of existing active substances || || 50 || 50 || 50 || 50 || 50 || 50 || 50 || 50 || 50

Renewal of active substance approvals || || 0 || 0 || 3 || 3 || 0 || 0 || 2 || 4 || 40

Authorisation of biocidal products || || 0 || 0 || 10 || 40 || 40 || 70 || 70 || 70 || 140

Amendments of Union authorisations || || 0 || 0 || 0 || 5 || 25 || 45 || 80 || 115 || 150

Opinion in case of disagreement during Mutual Recognition || || 30 || 30 || 30 || 30 || 30 || 30 || 30 || 30 || 30

|| || || || || || || || || ||

Total || || 85 || 85 || 98 || 133 || 150 || 200 || 237 || 274 || 415

These opinions will have to be turned into Commission
decisions through delegated and implementing acts.

This will represent a significant increase
to the current workload, for which additional resources will need to be
provided.

On the basis of the current practice and of
the experience of other Commission services, it is estimated that one AST will
be required for every 40 opinions. AD posts will also be needed to manage and
coordinate the team of AST.

The number of additional posts would thus
rise from 2 in 2013 to 12 in 2021.

|| 2012 || 2013 || 2014 || 2015 || 2016 || 2017 || 2018 || 2019 || 2020 || 2021

|| || || || || || || || || ||

AD || || 1 || 1 || 1 || 1 || 1 || 1 || 1 || 1 || 2

AST || || 1 || 1 || 1 || 3 || 3 || 5 || 6 || 7 || 10

Total || || 2 || 2 || 2 || 4 || 4 || 6 || 7 || 8 || 12

The additional posts of 2013 will be
provided through internal re-deployment. The evolution of the needs will be
assessed in the annual exercice of allocation of ressources.

[1]               ABM: Activity-Based Management – ABB: Activity-Based
Budgeting.

[2]               As referred to in Article 49(6)(a) or (b) of the
Financial Regulation.

[3]               The current Directive 98/8/EC provides for the
systematic evaluation of active substances, which were already on the market on
14 May 2000, when that Directive came into force. This evaluation is carried
out by Member States, which have all been allocated a number of substances for
which they have to produce assessment reports. These assessment reports are
then peer reviewed by the other Member States and discussed at different
meetings organised by the Commission JRC for the scientific and technical
issues and then by DG Environment for the final discussions before the final
steps of the decision-making process are taken (Comitology procedure). The
scientific and technical discussions and the associated preparatory work
(reading the reports and analysing the different issues) require significant
resources, which are currently provided by the Commission JRC and financed under
the LIFE + programme under budget line 07 03 07.

[4]               The duration of the action is not limited in time as
the proposal establishes the rules applicable to the placing on the market of
biocidal products. The financial impact is, however, expected to be limited to
supporting the European Chemicals Agency (ECHA) in taking up the additional
tasks related to the assessment of active substances used in biocidal products
and of certain biocidal products. ECHA will indeed receive from industry
specific fees for certain of these activities as well as an annual fee for
products authorised by the Union.
It is expected that ECHA will be taking steps to prepare for these tasks from
the year 2011. As 2013 is the last year of the current financial programming,
estimates of the commitment and payment appropriations have been limited to
that of 2012 and 2013 in this financial statement.             
A detailed analysis of the ECHA budget for these additional tasks is provided
in appendixes to this revised financial statement for the years 2012 and 2013
as well as for the next 8 following years (i.e. until 2021), in order to match
the timetable attached to the REACH revised legislative Financial Statement
(SEC(2006)924).

[5]               Details of management modes and references to the
Financial Regulation may be found on the BudgWeb site: http://www.cc.cec/budg/man/budgmanag/budgmanag_en.html

[6]               As referred to in Article 185 of the Financial
Regulation.

[7]               Diff. = Differentiated appropriations

[8]               EFTA: European Free Trade Association.

[9]               Candidate countries and, where applicable, potential
candidate countries from the Western Balkans.

[10]             Expenditure for 2012 are based on the subsidy to ECHA
from the date of adoption onwards. Some preparatory measures are also financed in
2011 and 2012 under the LIFE Programme (budget line 07 03 07) for an estimated
amount of 1,500 M€.

[11]             Technical and/or administrative assistance and
expenditure in support of the implementation of EU programmes and/or actions
(former "BA" lines), indirect research, direct research.

[12]             Outputs are products and services to be supplied (e.g.:
number of student exchanges financed, number of km of roads built, etc.).

[13]             20 2-day missions to Agency per year at 1,200 EUR per
mission

[14]             Standing Committee on Biocidal Products: 6 one-day
meetings per year at 30,000 EUR/meeting

[15]             CA= Contract Agent; INT= agency staff ("Intérimaire");
JED= "Jeune Expert en Délégation" (Young Experts in
Delegations); LA= Local Agent; SNE= Seconded National Expert;

[16]             Under the ceiling for external personnel from
operational appropriations (former "BA" lines).

[17]             Essentially for Structural Funds, European Agricultural
Fund for Rural Development (EAFRD) and European Fisheries Fund (EFF).

[18]             See points 19 and 24 of the Interinstitutional
Agreement.