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Document 52011SC1509
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TABLE OF CONTENTS – ANNEXES Annex 1 ... Procedures
for standardisation. …... 2 1............... Information
procedure. . 2 1.1............ Role of ESOs. . 2 2............... Mandates. . 2 2.1............ The
consultation process. . 2 2.2............ Role of ESOs. . 2 3............... Formal
objections. . 3 Annex 2.... Breakdown of new national standardisation
activities from notifications (CEN and CENELEC) in 2009 and 2010 by State. . 4 Annex 3.... Breakdown of new
national standardisation activities from notifications (CEN and CENELEC) from
1999 to 2010 by group of countries. . 5 Annex 4.... Sectoral breakdown of
notifications. . 6 Annex 5.... Mandates from 2006 to
2010 – total 7 Annex 6.... Commission Decisions
on formal objections in 2009 and 2010. . 8 Annex 7.... Brief description of
the notification procedure. . 10 Annex 8.... Developments in Court
of Justice case-law on the matter in 2009 and 2010. . 12 Annex 9.... Application of the
procedure in 2009 and 2010: notifications of technical regulations submitted by
the member states. . 13 9.1............ Volume of
notifications during the 2009-2010 period. . 14 9.2............ Breakdown by country. . 15 9.3............ Breakdown by
sector 18 9.4............ Commission
reactions: comments and detailed opinions in 2009 and 2010 (Articles 8(2)
and 9(2) of the Directive) 20 9.5............ Commission
reactions: blockages in 2009 and 2010 (Articles 9(3) and 9(4) of the
Directive) 21 9.6............ Member State
reactions. . 22 9.7............ Urgency
Procedure (Article 9(7) of the Directive) 23 9.8............ Follow-up to
Commission reactions. . 25 Annex 10 Application
of the procedure in 2009 and 2010: participation of EFTA countries signatory to
the EEA Agreement, of Switzerland and of Turkey. . 26 Annex 11 . Internet
consultations in 2009 and 2010. . 27
Annex 1 –
procedures for standardisation
1.
Information procedure
1.1.
Role of ESOs
The NSBs, which
are members of CEN and CENELEC (including bodies from the EFTA countries), send
the necessary information to the CEN Management Centre and the Central
Secretariat of CENELEC. The information gathered is sent monthly (except in the
summer and over the end of year period) by CEN and quarterly by CENELEC to the
Commission (DG Enterprise and Industry), all the members of CEN and CENELEC and
to ETSI. Within the
Commission, DG Enterprise and Industry disseminates both the regular returns
and the annual reports of CEN and CENELEC to the relevant services. ETSI takes part
in the information procedure, although its role is limited to receiving and
examining the information submitted by CEN and CENELEC members via the secretariats
of these two bodies.
2.
Mandates
2.1.
The consultation process
The Commission
requests the political and technical endorsement of its policy in a particular
area from the Member States. This is achieved by means of a consultation,
firstly informally with the standardisation bodies, stakeholders and Member
States through sectoral committees or expert groups and then formally with the
Member States through the Standing Committee. The consultation process is
co-ordinated by DG Enterprise and Industry. The Committee gives its opinion on
the draft mandate, an opinion that is fully respected by the Commission
services and that is acted upon wherever reasonable and possible. Following
this consultation – and any amendment arising from it – the mandates are
forwarded to the relevant ESOs for acceptance.
2.2.
Role of ESOs
The ESOs may
accept the mandate as issued by the Commission services, or indeed not accept
it if they so wish, by a decision made at Technical Board level. In practice,
as mandates are discussed with the ESOs prior to their being issued, refusal is
very rare and mandates are usually only not accepted if the work is outside the
scope of the ESO. The mandates can
be addressed to any one of the ESOs, or any combination of them, as the work
envisaged requires. It is common for
the ESOs to request co-funding for the mandated work following acceptance – by
means of action grants – although the issuance of the mandate itself does not
mean funding will necessarily be available and the request for funding must
undergo a thorough evaluation process by the Commission services.
3. Formal
objections
The procedure
begins with the formal objection either being received by the Commission
through the Permanent Representation or being launched by the Commission
itself. The documents are then circulated to the Committee, and normally a Member State expert group is also consulted for its opinion. Once a draft Commission
Decision is ready, the Committee is consulted. After receiving a positive
opinion, the Decision is processed further. Annex 2 Breakdown
of new national standardisation activities from
notifications (CEN and CENELEC) in 2009 and 2010 by
state Country || 2009 || 2010 || Total AT || 196 || 205 || 401 BE || 30 || 32 || 62 BG || 12 || 31 || 43 CH || 38 || 24 || 62 CY || 2 || 1 || 3 CZ || 70 || 53 || 123 DE || 424 || 368 || 792 DK || 8 || 1 || 9 EE || 9 || 18 || 27 ES || 208 || 196 || 404 FI || 3 || 0 || 3 FR || 277 || 221 || 498 GR || 0 || 464 || 464 HU || 7 || 7 || 14 IE || 4 || 9 || 13 IS || 0 || 0 || 0 IT || 123 || 265 || 388 LU || 0 || 0 || 0 LT || 3 || 44 || 47 LV || 33 || 11 || 44 MT || 0 || 1 || 1 NL || 59 || 62 || 121 NO || 17 || 15 || 32 PL || 14 || 27 || 41 PT || 0 || 0 || 0 RO || 45 || 2 || 47 SE || 21 || 18 || 39 SI || 11 || 8 || 19 SK || 29 || 26 || 55 UK || 159 || 138 || 297 || || || CEN || 1769 || 2190 || 3959 CENELEC || 99 || 57 || 156 From EU-15 || 1512 || 1979 || 3491 From EU-12 || 235 || 229 || 464 From EFTA || 55 || 39 || 94 TOTAL || 1802 || 2247 || 4049 Annex 3 Breakdown of new national
standardisation activities from notifications (CEN and CENELEC) from 1999
to 2010 by group of countries Annex
4 Sectoral breakdown of notifications 2009 || 2010 CEN Building and construction – Structures || 183 || Building and construction – Structures || 591 Food products || 70 || Building and construction – Fire protection || 75 Building and construction – Undetermined || 66 || Food products || 62 Mining || 61 || Services - Undetermined || 58 Building and construction – Fire protection || 54 || Health, environment and medical equipment - Undetermined || 56 Road Building and Maintenance || 44 || Water quality and water supply || 51 Non-metallic materials - Undetermined || 42 || Building and construction - Undetermined || 50 Aerospace || 41 || Petroleum products || 46 Optics || 39 || Air quality || 44 Road safety || 38 || Mechanical engineering - Fasteners || 40 Annex
5 Mandates from 2006 to 2010 – total Type || 2006 || 2007 || 2008 || 2009 || 2010 After formal objection (New Approach) || 4 || 2 || 0 || 0 || 0 Amendments (New Approach) || 4 || 0 || 1 || 4 || 0 New Approach mandates || 5 || 7 || 2 || 5 || 4 Mandates under other legislation || 7 || 5 || 9 || 10 || 12 Mandates under Community policy || 4 || 6 || 6 || 2 || 4 Total || 24 || 20 || 18 || 21 || 20 Annex
6 Commission Decisions on formal objections in 2009 and 2010 || Standard || Directive || Decision || Date Decision || Decision number || O.J. Reference decision publication || Date of reception || Days to close the case (aprox) 1 || EN 3-9:2006 - Portable fire extinguishers — Part 9: Additional requirements to EN 3-7 for pressure resistance of CO2 extinguishers || 97/23/EC Pressure Equipment || Non publication of the reference in the OJ || 10/02/2009 || C(2009) 666 || L 48/13 19.02.2010 || 06/07/2007 || 574 2 || EN 3-8:2006 - Portable fire extinguishers - Part 8: Additional requirements to EN 3-7 for the construction; resistance to pressure and mechanical tests for extinguishers with a maximum allowable pressure equal to or lower than 30 bar || 97/23/EC Pressure Equipment || Publication of the reference in the OJ || 10/02/2009 || C(2009) 739 || L 40/33 11.02.2010 || 06/07/2007 || 574 3 || EN 12312-9:2005 - Aircraft ground support equipment - Specific requirements - Part 9: Container/Pallet loaders || 2006/42/EC Machinery || publication with a restriction || 11/03/2009 || C(2009) 1551 || L 067/85 12.3.2009 || 19/10/2005 || 1222 4 || EN ISO 4869-4:2000 Acoustics - Hearing protectors - Part 3: Measurement of insertion loss of ear-muff type protectors using an acoustic test fixture || 89/686/EEC Personal Protective Equipment || Presumption of conformity withdrawn || 18/03/2010 || C(2010) 1599 || L 69/20 19.3.2010 || 05/11/2008 || 493 5 || EN 353-1:2002 Personal protective equipment against falls from height – Part 1: Guided type fall arresters including a rigid anchor line || 89/686/EEC Personal Protective Equipment || non-withdrawal of the reference of standard || 19/03/2010 || C(2010)1619 final || L 75/27 23.3.2010 || 29/10/2008 || 500 6 || EN 71-1:2005 – 5.12 Fillings (rembourrage) || 88/378/EEC Toys || non-withdrawal of the reference of standard || 09/06/2010 || C(2010)3571 final || non published || 15/05/2006 || 1464 7 || EN 71-8:2003/A2:2005 – Swings || 88/378/EEC Toys || Presumption of conformity partially withdrawn || 24/06/2010 || C(2010)4156 final || non published (but mentioned in the list published on OJEU C 236/3 01.09.2010) || 19/04/2006 || 1505 Annex 7 Brief description of the notification
procedure This annex gives
a general overview of the notification procedure for products and indicates the
specific procedural characteristics that apply to Information Society services.
For a more detailed description of the procedure, please refer to the
information brochure Guide to the procedure for the provision of information
in the field of technical standards and regulations and of rules on Information
Society services, available on the following website: http://ec.europa.eu/enterprise/tris. Legal
bases Introduced in
1984 by Directive 83/189/EEC[1],
the notification procedure in the field of technical regulations has gradually
been extended to all industrial, agricultural and fishery products. In 1998,
Directive 83/189/EEC was repealed and codified by Directive 98/34/EC[2], which in turn was amended by
Directive 98/48/EC[3]
in order to extend the notification procedure to Information Society services,
with the adaptations needed to take account of the demands of the sector. Obligation
to notify and standstill period Article 8(1) of
Directive 98/34/EC (hereinafter "the Directive") stipulates that the
Member States shall inform the Commission of any draft technical regulation
prior to its adoption. The simple transposition of a European Union act does
not require prior notification, unless the national authorities adopt national
provisions that go beyond mere compliance with European Union acts and that
contain technical regulations within the meaning of the Directive (Article 10
of the Directive). Starting from
the date of notification of the draft, a three-month standstill period –
during which the notifying Member State cannot adopt the technical regulation
in question – enables the Commission and the other Member States to examine the
notified text and to respond appropriately. The only derogation to this rule is
linked to the nature of the measure in question: for technical specifications
linked to fiscal or financial measures, there is no standstill period. This
also applies to technical regulations that have to be adopted urgently (see
below). Possible
reactions and consequences Where it emerges
that the notified drafts are liable to create barriers to the free movement of
goods or to the free provision of Information Society services (Articles 34-36,
49 and 56 of the Treaty on the Functioning of the European Union) or to
secondary legislation, the Commission and the other Member States may submit a detailed
opinion to the Member State that has notified the draft (Article 9(2) of
the Directive). The detailed opinion has the effect of extending the standstill
period by an additional three months. The Commission and the Member States can also make comments about a notified draft that appears to comply with European
Union law but that requires clarification in its interpretation
(Article 8(2)). The Commission can also block a draft for a period of 12
months if European Union harmonisation work is due to be undertaken or is
already underway in the same field (Article 9(3) to (5)). In the event of
a detailed opinion being issued, the Member State concerned informs the
Commission of the action that it intends to take in response to the detailed
opinion, and the Commission comments on that reaction (Article 9(2)). With
regard to the comments, even though the Directive does not lay down any legal
obligation for the Member State receiving the comments to indicate what
follow-up action it intends to take, the Member States are inclined to respond,
thus making the procedure a genuine instrument of dialogue. Urgency
procedure Article 9(7)
of the Directive describes an urgency procedure, which is designed to allow the
immediate adoption of a national draft, subject to a closed list of certain
conditions that must be clearly indicated at the time of notification (‘serious
and unforeseeable circumstances relating to the protection of public health or
safety, the protection of animals or the preservation of plants'). The aim
of the urgency procedure is to enable a notifying Member State faced with
serious or unforeseeable circumstances immediately to adopt the draft technical
regulation, without having to wait for the expiry of the three-month standstill
period. The Commission decides on the justification for the urgency procedure
as soon as possible. If the request to apply the urgency procedure is accepted
by the Commission, the three-monthe stanstill period does not apply and the
notified text can be adopted. Nevertheless, any examination of the substance of
the text can subsequently be carried out, as part of infringement proceedings
for breach of European Union law. Communication
of final texts At the end of
the 98/34 procedure, the Member States are bound to inform the Commission of
final texts as soon as those texts have been adopted and to indicate cases in
which the notified draft has been abandoned, in order to allow the 98/34
procedure to be closed (Article 8(3) of the Directive). ‘Technical
standards and regulations’ committee The Standing
Committee laid down in Article 5 of the Directive consists of representatives
appointed by the Member States and is chaired by a representative of the
Commission. In its ‘Technical standards and regulations’ configuration, the
Committee meets regularly and constitutes a forum for discussing all issues
connected with the application of the Directive. Application
of the 98/34 procedure to Information Society services The 98/34
procedure also applies to Information Society services, with the following
adaptations: a) in the event of
a detailed opinion being issued, the total standstill period is four months
from the date of the communication, instead of the six months stipulated for
products; b) the Commission can only block the draft for a maximum of 12 months
if the subject of the draft is already covered by an EU Council proposal and if
the notified text contains provisions that do not comply with the proposal
drafted by the Commission; c) the urgency procedure can be invoked not only
under the circumstances stipulated for products ('serious and unforeseeable
circumstances') but also 'for urgent reasons ... relating to public
safety'. The
simplified procedure EFTA countries that are contracting parties to the Agreement on the
European Economic Area (‘EEA’), namely Norway, Iceland and Liechtenstein, apply
the 98/34 procedure with the necessary adaptations[4]: they notify their drafts via
the EFTA Surveillance Authority and can comment on the drafts notified by the
27 Member States. On the other hand the entire European Union can comment on
drafts notified by the three countries signatory to the EEA Agreement. Switzerland (which is part of EFTA, but which does
not apply the EEA Agreement) also participates in the system. This country
applies the 98/34 procedure on a voluntary basis following an informal
agreement to exchange information in the field of technical regulations: it
submits its drafts to the Commission and can make and receive comments on the
notified drafts. Turkey, which transposed the Directive in
2002, participates in the procedure in the same manner as the EFTA countries.
The decision to have Turkey participate in the notification system was taken in
1997 as part of the implementation of the final phase of the Customs Union
between Turkey and the European Community. Annex
8 Developments in Court of Justice case-law on the matter in 2009 and 2010 During the 2009-2010
period one Court of Justice judgment has been delivered on Directive 98/34/EC. In the case Lars
Sandström (Judgment of 15 April 2010, Case C-433/05, OJ C 148 of 5 June
2010, p.2) the Court of Justice clarifies the concept of significant alteration
of the draft for the purposes of the third subparagraph of Article 8.1 of the
Directive. It stated that
"an amendment made to a draft technical regulation already notified to the
European Commission, pursuant to the first subparagraph of that provision, and
which contains, in relation to the notified draft, merely a relaxation of the
conditions of use of the product in question and which, therefore, reduces the
possible impact of the technical regulation on trade, is not a significant
alteration of the draft for the purposes of the third subparagraph of that
provision and need not be notified beforehand to the Commission". It should be
pointed out that, like other Court of Justice judgments on the notification
procedure, this judgment can be consulted on the following website: http://curia.europa.eu/jcms/jcms/Jo1_6308/). Annex
9 Application of the procedure in 2009 and 2010: notifications of technical
regulations submitted by the member states Annexes 9.1,
9.2 and 9.3 give a statistical overview of the development of the number of
draft technical regulations notified by the Member States in 2009 and 2010, and
of their breakdown by Member State and by sector. It should be pointed out
that, in accordance with Article 11 of the Directive, ‘statistics concerning
communications received’ as part of the notification procedure are published
once a year in the Official Journal, C series[5]. The reactions to
the notified drafts – in the form of comments or detailed opinions from the
Commission or the Member States, or of blockages on the part of the Commission
– are illustrated in Annexes 9.4 to 9.6. Annex 9.7 refers to the requests to apply the urgency procedure
that the Member States addressed to the Commission pursuant to
Article 9(7) of the Directive. Annex 9.8 shows the action taken by the Member States in
response to the Commission’s reactions. 9.1 Volume
of notifications during the 2009-2010 period Figure 1 2009 2010 The statistics in figure 1 show that the
Member States notified to the Commission 708 draft regulations in 2009 and 817
in 2010. 9.2 Breakdown
by country Figure 2 During the 2009-2010 period, the two Member States which notified the
most draft technical regulations were France (155) and Germany (120). A group of three other countries (Netherlands, United Kingdom and Spain) come next with a total number of notifications of between 100 and 117. Table 1 –
Number of notifications of technical regulations submitted by the Member States
in 2009 and 2010 Member States || 2009 || 2010 Austria || 43 || 48 Belgium || 51 || 31 Bulgaria || 8 || 5 Cyprus || 1 || 6 Czech Republic || 26 || 26 Denmark || 34 || 45 Estonia || 15 || 5 Finland || 31 || 34 France || 56 || 99 Germany || 64 || 56 Greece || 9 || 7 Hungary || 20 || 10 Ireland || 8 || 9 Italy || 31 || 41 Latvia || 15 || 12 Lithuania || 9 || 8 Luxembourg || 1 || 63 Malta || 9 || 12 Netherlands || 67 || 50 Poland || 20 || 42 Portugal || 9 || 7 Romania || 14 || 41 Slovakia || 16 || 14 Slovenia || 14 || 7 Spain || 52 || 47 Sweden || 31 || 40 United Kingdom || 54 || 52 Total || 708 || 817 Table 2 –
Percentages of notifications submitted by the Member States in 2009 and 2010 Member States || 2009 || 2010 Austria || 6.1% || 5.9% Belgium || 7.2% || 3.8% Bulgaria || 1.1% || 0.6% Cyprus || 0.1% || 0.7% Czech Republic || 3.7% || 3.2% Denmark || 4.8% || 5.5% Estonia || 2.1% || 0.6% Finland || 4.4% || 4.2% France || 7.9% || 12.1% Germany || 9.0% || 6.9% Greece || 1.3% || 0.9% Hungary || 2.8% || 1.2% Ireland || 1.1% || 1.1% Italy || 4.4% || 5.0% Latvia || 2.1% || 1.5% Lithuania || 1.3% || 1.0% Luxembourg || 0.1% || 7.7% Malta || 1.3% || 1.5% Netherlands || 9.5% || 6.1% Poland || 2.8% || 5.1% Portugal || 1.3% || 0.9% Romania || 2.0% || 5.0% Slovakia || 2.3% || 1.7% Slovenia || 2.0% || 0.9% Spain || 7.3% || 5.8% Sweden || 4.4% || 4.9% United Kingdom || 7.6% || 6.4% 9.3 Breakdown
by sector Figure 3 Building and
construction are constantly increasing and
represent the sector with the highest number of notifications during the period
in question (354 notifications). They are followed by the foodstuffs and
agricultural products sector (224 notifications). In 2009 and 2010, the transport
sector grew (178 notifications). Information Society services
represent on average 5.5% of the total number of notifications. Tables 3 and 4 – Breakdown by sector of
the drafts notified by the Member States of the European Union in 2009 and 2010 Sectors || 2009 || || Sectors || 2010 Building and construction || 132 || 18.6% || || Building and construction || 222 || 27.2% Foodstuffs and agricultural products || 105 || 14.8% || || Foodstuffs and agricultural products || 119 || 14.6% Chemicals || 21 || 3.0% || || Chemicals || 19 || 2.3% Pharmaceuticals || 23 || 3.2% || || Pharmaceuticals || 23 || 2.8% Domestic and leisure equipment || 23 || 3.2% || || Domestic and leisure equipment || 47 || 5.8% Mechanical engineering || 39 || 5.5% || || Mechanical engineering || 46 || 5.6% Energy, ores, wood || 40 || 5.6% || || Energy, ores, wood || 35 || 4.3% Environment, packaging || 62 || 8.8% || || Environment, packaging || 47 || 5.8% Health, medical equipment || 9 || 1.3% || || Health, medical equipment || 5 || 0.6% Transport || 114 || 16.1% || || Transport || 64 || 7.8% Telecommunications || 70 || 9.9% || || Telecommunications || 86 || 10.5% Miscellaneous products || 39 || 5.5% || || Miscellaneous products || 51 || 6.2% Information Society services || 31 || 4.4% || || Information Society services || 53 || 6.5% 9.4 Commission
reactions: comments and detailed opinions in 2009 and 2010 (Articles 8(2)
and 9(2) of the Directive) Table 7 Year || Comments || Detailed opinions 2009 || 154 || 57 2010 || 108 || 48 The number of detailed
opinions issued by the Commission during the period in question decreased: 57 detailed
opinions in 2009 on a total number of 708 notifications (8.05%) and in 2010, 48
detailed opinions on a total number of 817 notifications (5.87%). The number of comments
made by the Commission also decreased: from 154 in 2009 to 108 in 2010. Figure 4 9.5 Commission
reactions: blockages in 2009 and 2010 (Articles 9(3) and 9(4) of the
Directive) During the 2009-2010
period, the Commission requested a 12-month postponement of the adoption of 11
draft regulations notified by the Member States, because they concerned a
subject on which Community harmonisation work had already been announced or was
underway. Table 8 Year || Standstills || Total Announcement of a Community text (Article 9(3)) || Presentation to the Council of a Community text (Article 9(4)) 2009 || 3 || 3 || 6 2010 || 2 || 3 || 5 9.6 Member
States reactions Table 9 – Comments
and detailed opinions issued by the Member States in 2009 and 2010
(Articles 8(2) and 9(2)) || 2009 || 2010 || Com. || D.O. || Com. || D.O. Austria || 10 || 1 || 4 || 1 Belgium || 3 || 3 || 8 || 3 Bulgaria || 1 || 0 || 1 || 0 Cyprus || 0 || 0 || 3 || 1 Czech Republic || 6 || 0 || 15 || 1 Denmark || 3 || 1 || 12 || 0 Estonia || 6 || 0 || 3 || 0 Finland || 9 || 1 || 6 || 1 France || 22 || 23 || 14 || 7 Germany || 12 || 8 || 10 || 8 Greece || 11 || 4 || 0 || 0 Hungary || 6 || 0 || 2 || 0 Ireland || 0 || 0 || 4 || 1 Italy || 24 || 18 || 14 || 14 Latvia || 8 || 1 || 10 || 3 Lithuania || 1 || 0 || 3 || 0 Luxembourg || 0 || 0 || 2 || 0 Malta || 1 || 4 || 2 || 0 Netherlands || 7 || 0 || 4 || 0 Poland || 4 || 3 || 15 || 2 Portugal || 5 || 0 || 2 || 0 Romania || 4 || 1 || 9 || 3 Slovakia || 8 || 4 || 1 || 0 Slovenia || 3 || 0 || 2 || 0 Spain || 16 || 1 || 13 || 2 Sweden || 4 || 0 || 10 || 1 United Kingdom || 9 || 1 || 2 || 8 Total || 183 || 74 || 171 || 56 9.7 Urgency
Procedure (Article 9(7) of the Directive) Table 10 – Requests to apply the urgency
procedure received in 2009 and 2010 YEAR || 2009 || 2010 COUNTRY || Requests || Favourable opinion || Requests || Favourable opinion Austria || 2 || 2 || 2 || 2 Belgium || 1 || 0 || 2 || 2 Bulgaria || 0 || 0 || 0 || 0 Cyprus || 0 || 0 || 0 || 0 Czech Rep. || 0 || 0 || 0 || 0 Denmark || 0 || 0 || 1 || 1 Estonia || 0 || 0 || 0 || 0 Finland || 1 || 0 || 1 || 1 France || 0 || 0 || 4 || 2 Germany || 2 || 2 || 1 || 1 Greece || 0 || 0 || 0 || 0 Hungary || 0 || 0 || 0 || 0 Ireland || 0 || 0 || 2 || 2 Italy || 0 || 0 || 0 || 0 Latvia || 0 || 0 || 0 || 0 Lithuania || 1 || 0 || 0 || 0 Luxembourg || 0 || 0 || 0 || 0 Malta || 0 || 0 || 1 || 0 Netherlands || 0 || 0 || 0 || 0 Poland || 0 || 0 || 2 || 2 Portugal || 3 || 0 || 0 || 0 Romania || 2 || 0 || 4 || 2 Slovakia || 0 || 0 || 0 || 0 Slovenia || 0 || 0 || 0 || 0 Spain || 3 || 0 || 6 || 0 Sweden || 5 || 5 || 6 || 5 United Kingdom || 0 || 0 || 0 || 0 Total || 20 || 9 || 32 || 20 Table 10 provides an overview of the number of requests to apply the urgency
procedure, by Member State and by year; it also shows the number of requests to
which the Commission gave a favourable opinion (29 out of the 52 made during
the entire 2009-2010 period). Table 11 –
Breakdown by sector of the requests to apply the urgency procedure in 2009 and 2010. Table 11, which gives a sectoral breakdown of the requests to apply the
urgency procedure received by the Commission during the 2009-2010 period, shows
that the application of this exceptional procedure was invoked mainly in the pharmaceutical
and cosmetics sector (15 requests) and in the goods and miscellaneous products
sector (5). 9.8 Follow-up
to Commission reactions Table 12 shows
that, in 2009, the recipient Member States responded to 51 of the
57 detailed opinions issued by the Commission (89.5%) and that 20 responses
were deemed satisfactory by the Commission (39.2%). In 2010, they
responded to 40 of the 48 detailed opinions (83.3%), 10 were satisfactory (25%).
Table 12* Year || Detailed opinions || Responses from the Member States || Satisfactory || Closures 2009 || 57 || 51 || 20 || 4 2010 || 48 || 40 || 10 || 4 *Data at 04/06/2011 Table 13 Year || Observations COM || Responses from the Member States 2009 || 154 || 105 2010 || 108 || 67 Table 13 shows
that, in 2009, the recipient Member States responded to 105 of
the 154 observations issued by the Commission (68.2 %) and in 2010, they
responded to 67 of the 108 (62 %). Annex 10 Application
of the procedure in 2009 and 2010: participation of EFTA countries
signatory to the EEA Agreement, of Switzerland and
of Turkey Table 13 –
Number of notifications from EFTA countries and comments issued to them by the
European Union || 2009 || 2010 Notifications || Com. EU || Notifications || Com. EU EFTA || Norway || 8 || 5 || 10 || 0 Liechtenstein || 6 || 4 || 8 || 0 Iceland || 1 || 1 || 1 || 0 Table 14 –
Number of notifications submitted by Switzerland and Turkey and comments issued
to them by the Commission or the Member States || 2009 || 2010 Notifications || Com. || Notifications || Com. || Switzerland || 9 || 1 || 5 || 0 || Turkey || 3 || 2 || 2 || 2 Table 15 –
Number of comments from EFTA, Switzerland and Turkey regarding the
notifications from the Member States || 2009 || 2010 || EFTA || 0 || 0 || Switzerland || 0 || 0 || Turkey || 0 || 0 Annex
11 – Internet consultations in 2009 and 2010 Figure 5 [1] Directive
of 28 March 1983, OJ L 109/8 of 26.4.1983 [2] O L
204/37 of 21.7.1998. [3] O L
217/18 of 5.8.1998. [4] Annex
II, Chapter XIX, point 1 to the EEA Agreement, which includes Article 8(2)
of the Directive [5] For 2009: OJ C 164/3 of 24.06.2010; for 2010: OJ C
147/07 of 18 May 2011