ISSN 1977-0677 doi:10.3000/19770677.L_2012.037.eng |
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Official Journal of the European Union |
L 37 |
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English edition |
Legislation |
Volume 55 |
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Corrigenda |
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(1) Text with EEA relevance |
EN |
Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period. The titles of all other Acts are printed in bold type and preceded by an asterisk. |
II Non-legislative acts
REGULATIONS
10.2.2012 |
EN |
Official Journal of the European Union |
L 37/1 |
COMMISSION REGULATION (EU) No 109/2012
of 9 February 2012
amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex XVII (CMR substances)
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (1), and in particular Article 68(2) thereof,
Whereas:
(1) |
Annex XVII to Regulation (EC) No 1907/2006, in its entries 28 to 30, prohibits the sale to the general public of substances that are classified as carcinogenic, mutagenic or toxic for reproduction (CMR), categories 1A or 1B or of mixtures containing them in concentration above specified concentration limits. The substances concerned are listed in Appendices 1 to 6 to Annex XVII. |
(2) |
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (2) was amended on 5 September 2009 by Commission Regulation (EC) No 790/2009 (3) in order to include a number of newly classified CMR substances. Appendices 1 to 6 to Annex XVII to Regulation (EC) No 1907/2006 should be amended in order to align them to the entries concerning CMR substances in Regulation (EC) No 790/2009. |
(3) |
Under Article 68 (2) of Regulation (EC) No 1907/2006, restrictions may be proposed on the consumer use of CMR substances categories 1A and 1B on their own, in a mixture or in an article. |
(4) |
A number of boron compounds were found to be toxic for reproduction and were classified as toxic for reproduction, hazard class and category Repr. 1B, hazard statement H360FD under the Regulation (EC) No 790/2009. A market survey conducted for the Commission (4) on the uses of borates in mixtures sold to the general public reported that sodium perborate, tetra and monohydrate, are used in a concentration exceeding their specific concentration limit specified in Regulation (EC) No 790/2009 in household detergents and cleaners. |
(5) |
On 29 April 2010, the Risk Assessment Committee (RAC) of the European Chemicals Agency (ECHA) gave an opinion on the use of boron compounds in photographic applications (5). In its opinion, the RAC noted that there were ‘more possible sources that contribute to the total exposure to boron of consumers’, and that these ‘additional sources have to be considered in the risk assessment of boron compounds’. Multiple sources of exposure to boron of consumers were not considered in previous risk assessments, in contrast with current concerns with multiple sources of exposure in general. |
(6) |
Sodium perborate, tetra and monohydrate, are mainly used as bleaching agents in laundry detergents and machine dishwashing products. The Rapporteur Member State, responsible for conducting the risk evaluation on sodium perborate under Council Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances (6), submitted a dossier in accordance with Annex XV of Regulation (EC) No 1907/2006 to the European Chemicals Agency pursuant to Article 136 of that Regulation. That risk assessment, published in 2007, concluded that the use of sodium perborate in laundry detergents and household cleaners, considered in isolation as a single source of exposure to boron, did not pose an unacceptable risk to the general public. Nevertheless, because the sources of exposure of the general public to boron are multiple, as expressed in the 2010 opinion of the RAC, and due to its reproductive toxicity it is desirable to reduce the exposure of the general public to boron. Moreover, because the consumer population exposed to boron from household detergents and cleaners is considerable, and because alternatives to perborates are available in these applications, it is appropriate to restrict the use of perborates in household detergents and cleaners. However, in order to allow certain manufacturers to adapt and replace, where necessary, boron compounds with alternatives in these applications, a time-limited derogation should be granted. |
(7) |
The measures provided for in this Regulation are in accordance with the opinion of the Committee established under Article 133 of Regulation (EC) No 1907/2006, |
HAS ADOPTED THIS REGULATION:
Article 1
Annex XVII to Regulation (EC) No 1907/2006 is amended in accordance with the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
It shall apply on 1 June 2012.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 9 February 2012.
For the Commission
The President
José Manuel BARROSO
(1) OJ L 396, 30.12.2006, p. 1.
(2) OJ L 353, 31.12.2008, p. 1.
(4) http://ec.europa.eu/enterprise/sectors/chemicals/files/docs_studies/final_report_borates_en.pdf
(5) http://echa.europa.eu/home_en.asp
ANNEX
Annex XVII to Regulation (EC) No 1907/2006 is amended as follows:
(1) |
In the table setting out the designation of the substances, groups of substances and mixtures and the conditions of restriction, in Column 2 of entries 28, 29 and 30, in paragraph 2, the following point (e) is added:
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(2) |
In the Appendices 1 to 6, in the foreword, a note B is inserted between note A and note C, as follows: ‘ Note B: Some substances (acids, bases, etc.) are placed on the market in aqueous solutions at various concentrations and, therefore, these solutions require different classification and labelling since the hazards vary at different concentrations.’ |
(3) |
In Appendix 1 the table is amended as follows:
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(4) |
In Appendix 2 the Table is amended as follows:
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(5) |
In Appendix 4, the table is amended as follows:
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(6) |
In Appendix 5, the table is amended as follows: The following entries are inserted in accordance with the order of the entries set out in Appendix 5 of Annex XVII of Regulation (EC) No 1907/2006:
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(7) |
In Appendix 6, the table is amended as follows:
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(8) |
The following Appendix 11 is inserted: ‘Appendix 11 Entries 28 to 30 — Derogations for specific substances
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10.2.2012 |
EN |
Official Journal of the European Union |
L 37/50 |
COMMISSION IMPLEMENTING REGULATION (EU) No 110/2012
of 9 February 2012
amending Annex II to Decision 2007/777/EC and Annex I to Regulation (EC) No 798/2008 as regards the entries for South Africa in the lists of third countries or parts thereof
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption (1) and in particular the introductory phrase of Article 8, the first subparagraph of point 1 of Article 8 and point 4 of Article 8 thereof,
Having regard to Council Directive 2009/158/EC of 30 November 2009 on animal health conditions governing intra-Community trade in, and imports from third countries of, poultry and hatching eggs (2), and in particular Articles 23(1) and 24(2) thereof,
Whereas:
(1) |
Commission Decision 2007/777/EC of 29 November 2007 laying down the animal and public health conditions and model certificates for imports of certain meat products and treated stomachs, bladders and intestines for human consumption from third countries and repealing Decision 2005/432/EC (3) lays down rules on imports into the Union and the transit and storage in the Union of consignments of meat products, and of consignments of treated stomachs, bladders and intestines, as defined in Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin (4). |
(2) |
Decision 2007/777/EC also lays down lists of third countries and parts thereof from which such imports into, transit and storage within the Union are to be authorised, sets out the model public and animal health certificates, and the rules on the origin and treatments required for those imported products. |
(3) |
Commission Regulation (EC) No 798/2008 of 8 August 2008 laying down a list of third countries, territories, zones or compartments from which poultry and poultry products may be imported into and transit through the Community and the veterinary certification requirements (5) lays down veterinary certification requirements for imports into and transit, including storage during transit, through the Union of poultry, hatching eggs, day-old chicks, specified pathogen-free eggs, meat, minced meat and mechanically separated meat of poultry, including ratites and wild game birds, eggs and egg products. That Regulation provides that those commodities are only to be imported into the Union from the third countries, territories, zones or compartments listed in Part 1 of Annex I thereto. |
(4) |
Regulation (EC) No 798/2008 also sets out the conditions for a third country, territory, zone or compartment to be considered as free from highly pathogenic avian influenza (HPAI) and the requirements for the veterinary certification in that respect for commodities destined for imports into the Union. |
(5) |
In April 2011, South Africa notified the Commission of an outbreak of highly pathogenic avian influenza (HPAI) on its territory. As a consequence, Decision 2007/777/EC and Regulation (EC) No 798/2008 were amended by Commission Implementing Regulation (EU) No 536/2011 (6), in order to provide for certain specific treatments for imports from that third country of meat products, treated stomachs, bladders and intestines for human consumption obtained from meat of farmed ratites and of biltong/jerky and pasteurised meat products consisting of, or containing meat of farmed feathered game, ratites and wild game birds. |
(6) |
In addition, imports into the Union of breeding and productive ratites and of day-old chicks, hatching eggs and meat of ratites were no longer authorised from the whole territory of South Africa covered by Regulation (EC) No 798/2008, as from the date of confirmation of the outbreak of HPAI, on 9 April 2011. |
(7) |
After the entry into force of Implementing Regulation (EU) No 536/2011, South Africa submitted information to the Commission on the control measures taken and the development of the epidemiological situation in relation to the outbreak of HPAI. The disease control and surveillance efforts undertaken by South Africa were considered sufficient to ensure that South Africa was able to limit the spread of disease and contain it to a defined area. |
(8) |
As a consequence, Decision 2007/777/EC and Regulation (EC) No 798/2008 were amended by Commission Implementing Regulation (EU) No 991/2011 (7). By that amendment, imports into the Union of ratite meat and of certain meat products from the part of South Africa which was not placed under animal health restrictions (territory ZA-2) were again authorised. Implementing Regulation (EU) No 991/2011 entered into force on 9 October 2011. |
(9) |
Following the two successive amendments, the different Parts of Annex II to Decision 2007/777/EC currently list territory ZA-2 of South Africa as authorised for imports into the Union of consignments of certain meat products, treated stomachs, bladders and intestines for human consumption and of biltong/jerky and pasteurised meat products of poultry, farmed feathered game, including ratites, and wild game birds which undergo specific treatments set out in that Annex. |
(10) |
In addition, territory ZA-2 is currently listed in Part 1 of Annex I to Regulation (EC) No 798/2008 as authorised for imports into the Union of meat of ratites, as from the entry into force of Implementing Regulation (EU) No 991/2011. |
(11) |
On 13 October 2011, South Africa informed the Commission of a suspected outbreak of HPAI in the area that had earlier been considered as free of that disease. South Africa also informed the Commission that, in view of that suspicion, it has prohibited the dispatch of consignments of ratite meat and certain ratite meat products bound for the Union. |
(12) |
On 14 November 2011, South Africa notified outbreaks of HPAI to the World Organisation for Animal Health (OIE) that are located outside of the disease-affected area established by South Africa and as recognised by Implementing Regulation (EU) No 991/2011. The whole territory of that third country may therefore no longer be considered as free from HPAI. |
(13) |
Given the unfavourable development of the disease situation in South Africa and in order to avoid misunderstandings concerning commodities produced before the confirmation of the recent outbreak of HPAI, it is appropriate to amend the entry for South Africa in Part 1 of Annex I to Regulation (EC) No 798/2008 to prohibit imports into the Union of meat of ratites and to indicate the date of the confirmation of the initial outbreak of HPAI, on 9 April 2011 as ‧closing date‧ in column 6A in that Part. |
(14) |
In addition, as a consequence of the outbreak of HPAI, territory ZA-2 of South Africa no longer complies with the animal health conditions for applying ‧treatment A‧ to commodities consisting of, or containing meat of farmed ratites or treated stomachs, bladders and intestines of ratites for human consumption listed in Part 2 of Annex II to Decision 2007/777/EC and for applying ‧treatment E‧ to biltong/jerky and pasteurised meat products consisting of, or containing meat of poultry, farmed feathered game, ratites and wild game birds, listed in Part 3 of that Annex. Those treatments are insufficient to eliminate animal health risks linked to those commodities. The entry for South Africa as regards territory ZA-2 in Part 1 Annex II to Decision 2007/777/EC and the entries for South Africa in Parts 2 and 3 of that Annex should therefore be amended, in order to provide for an adequate treatment thereof. |
(15) |
Decision 2007/777/EC and Regulation (EC) No 798/2008 should therefore be amended accordingly. |
(16) |
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, |
HAS ADOPTED THIS REGULATION:
Article 1
Annex II to Decision 2007/777/EC is amended in accordance with Annex I to this Regulation.
Article 2
Annex I to Regulation (EC) No 798/2008 is amended in accordance with Annex II to this Regulation.
Article 3
This Regulation shall enter into force on the third day following its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 9 February 2012.
For the Commission
The President
José Manuel BARROSO
(1) OJ L 18, 23.1.2003, p. 11.
(2) OJ L 343, 22.12.2009, p. 74.
(3) OJ L 312, 30.11.2007, p. 49.
(4) OJ L 139, 30.4.2004, p. 55.
ANNEX I
Annex II to Decision 2007/777/EC is amended as follows:
(1) |
in Part 1, in the entry for South Africa, the entry ‧ZA-2‧ is deleted; |
(2) |
Part 2 is amended as follows:
|
(3) |
in Part 3, the entry for South Africa is replaced by the following:
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ANNEX II
In Part 1 of Annex I to Regulation (EC) No 798/2008, the entry for South Africa is replaced by the following:
‧ZA — South Africa |
ZA-0 |
Whole country |
SPF |
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EP, E |
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S4‧ |
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BPR |
I |
P2 |
9.4.2011 |
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A |
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DOR |
II |
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HER |
III |
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RAT |
VII |
P2 |
9.4.2011 |
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10.2.2012 |
EN |
Official Journal of the European Union |
L 37/55 |
COMMISSION IMPLEMENTING REGULATION (EU) No 111/2012
of 9 February 2012
opening the tendering procedure for aid for private storage of olive oil
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (1), and in particular Article 43(a), (d) and (j), in conjunction with Article 4 thereof,
Whereas:
(1) |
Article 33 of Regulation (EC) No 1234/2007 provides that the Commission may decide to authorise bodies, offering sufficient guarantees and approved by the Member States, to conclude contracts for the storage of olive oil that they market in the event of a serious disturbance on the market in certain regions of the European Union. |
(2) |
In Spain and Greece, Member States that together produce more than two thirds of the total olive oil production in the Union, the average olive oil price recorded on the market during the period specified in Article 4 of Commission Regulation (EC) No 826/2008 of 20 August 2008 laying down common rules for the granting of private storage aid for certain agricultural products (2), is below the level indicated in Article 33 of Regulation (EC) No 1234/2007. This causes a serious disturbance on the markets of those Member States. The Union olive oil market is characterised by a high level of interdependence and therefore the serious disturbance of the Spanish and Greek market risks to propagate to all the olive oil producing Member States. |
(3) |
Article 31 of Regulation (EC) No 1234/2007 provides that aid for private storage may be granted for olive oil and that the aid should be fixed by the Commission in advance or by means of a tendering procedure. |
(4) |
Regulation (EC) No 826/2008 has established common rules for the implementation of the private storage aid scheme. Pursuant to Article 6 of that Regulation, a tendering procedure is to be opened in accordance with the detailed rules and conditions provided for in its Article 9. |
(5) |
The global quantity up to which private storage aid can be granted should be set at a level which, according to market analysis, would contribute to the stabilisation of the market. |
(6) |
In order to facilitate the administrative and control work relating to the conclusion of contracts, the minimum quantity of product each tender must provide for should be fixed. |
(7) |
A security should be fixed in order to ensure that the operators fulfil their contractual obligations and that the measure will have its desired effect on the market. |
(8) |
In the light of the evolution of the market situation in the current marketing year and the forecasts for the following marketing year, the Commission should have the possibility to decide to shorten the term of contracts which are being performed and adjust the level of aid accordingly. That possibility has to be included in the contract, as provided for by Article 21 of Regulation (EC) No 826/2008. |
(9) |
Pursuant to Article 12(3) of Regulation (EC) No 826/2008, the time period of notification of all valid tenders by Member States to the Commission is to be fixed. |
(10) |
In order to prevent uncontrolled price falls, to react swiftly to the exceptional market situation and to ensure efficient management of this measure, this Regulation should enter into force on the day following that of its publication in the Official Journal of the European Union. |
(11) |
The Management Committee for the Common Organisation of Agricultural Markets has not delivered an opinion within the time limit set by its Chair, |
HAS ADOPTED THIS REGULATION:
Article 1
Subject matter
1. A tendering procedure is hereby opened in order to determine the level of aid for private storage referred to in Article 31(1)(b) of Regulation (EC) No 1234/2007 for the categories of olive oil listed in the Annex to this Regulation and defined in point 1 of Annex XVI to Regulation (EC) No 1234/2007.
2. The global quantity up to which aid for private storage can be granted shall be 100 000 tonnes.
Article 2
Applicable rules
Regulation (EC) No 826/2008 shall apply save as otherwise provided for in this Regulation.
Article 3
Submission of tenders
1. The sub-period during which tenders may be submitted in response to the first partial invitation to tender shall begin on 17 February 2012 and shall end on 21 February 2012 at 11:00 Brussels time.
The sub-period during which tenders may be submitted in response to the second partial invitation to tender shall begin on the first working day following the end of the preceding sub-period and shall end on 1 March 2012 at 11:00 Brussels time.
2. Tenders shall relate to a storage period of 150 days.
3. Each tender shall cover a minimum quantity of at least 50 tonnes.
4. Where an operator takes part in a tendering procedure for more than one category of oil or for vats located at different addresses, it shall submit a separate tender in each case.
5. Tenders may be lodged only in Greece, Spain, France, Italy, Cyprus, Malta, Portugal and Slovenia.
Article 4
Securities
Tenderers shall establish a security of EUR 50 per tonne of olive oil covered by a tender.
Article 5
Shortening the term of contracts
The Commission may, on the basis of developments on the market in olive oil and the outlook for the future, decide, in accordance with the procedure referred to in Article 195(2) of Regulation (EC) No 1234/2007, to shorten the term of contracts which are being performed and adjust the amount of the aid accordingly. The contract with the successful tenderer shall include reference to this option.
Article 6
Notification of the tenders to the Commission
In accordance with Article 12 of Regulation (EC) No 826/2008 all valid tenders shall be notified separately by Member States to the Commission, within 24 hours from the end of each tendering sub-period as referred to in Article 3(1) of this Regulation.
Article 7
Entry into force
This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 9 February 2012.
For the Commission, On behalf of the President,
Dacian CIOLOȘ
Member of the Commission
ANNEX
Olive oil categories referred to in Article 1(1)
Extra virgin olive oil
Virgin olive oil
10.2.2012 |
EN |
Official Journal of the European Union |
L 37/58 |
COMMISSION IMPLEMENTING REGULATION (EU) No 112/2012
of 9 February 2012
establishing the standard import values for determining the entry price of certain fruit and vegetables
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (1),
Having regard to Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors (2), and in particular Article 136(1) thereof,
Whereas:
(1) |
Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto. |
(2) |
The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the Official Journal of the European Union, |
HAS ADOPTED THIS REGULATION:
Article 1
The standard import values referred to in Article 136 of Implementing Regulation (EU) No 543/2011 are fixed in the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 9 February 2012.
For the Commission, On behalf of the President,
José Manuel SILVA RODRÍGUEZ
Director-General for Agriculture and Rural Development
ANNEX
Standard import values for determining the entry price of certain fruit and vegetables
(EUR/100 kg) |
||
CN code |
Third country code (1) |
Standard import value |
0702 00 00 |
IL |
156,8 |
MA |
56,5 |
|
TN |
86,5 |
|
TR |
129,9 |
|
ZZ |
107,4 |
|
0707 00 05 |
EG |
229,9 |
JO |
137,5 |
|
TR |
177,0 |
|
US |
57,6 |
|
ZZ |
150,5 |
|
0709 91 00 |
EG |
330,9 |
ZZ |
330,9 |
|
0709 93 10 |
MA |
92,0 |
TR |
185,9 |
|
ZZ |
139,0 |
|
0805 10 20 |
EG |
47,7 |
IL |
74,1 |
|
MA |
55,9 |
|
TN |
51,5 |
|
TR |
75,8 |
|
ZZ |
61,0 |
|
0805 20 10 |
IL |
134,2 |
MA |
78,0 |
|
ZZ |
106,1 |
|
0805 20 30 , 0805 20 50 , 0805 20 70 , 0805 20 90 |
CN |
60,1 |
EG |
95,0 |
|
IL |
91,6 |
|
JM |
98,5 |
|
MA |
89,3 |
|
TR |
74,6 |
|
ZZ |
84,9 |
|
0805 50 10 |
EG |
54,8 |
TR |
64,2 |
|
ZZ |
59,5 |
|
0808 10 80 |
CL |
98,4 |
CN |
111,2 |
|
MA |
59,2 |
|
MK |
31,8 |
|
US |
140,1 |
|
ZZ |
88,1 |
|
0808 30 90 |
CL |
48,2 |
CN |
49,3 |
|
US |
122,2 |
|
ZA |
100,2 |
|
ZZ |
80,0 |
(1) Nomenclature of countries laid down by Commission Regulation (EC) No 1833/2006 (OJ L 354, 14.12.2006, p. 19). Code ‘ ZZ ’ stands for ‘of other origin’.
DIRECTIVES
10.2.2012 |
EN |
Official Journal of the European Union |
L 37/60 |
COMMISSION DIRECTIVE 2012/2/EU
of 9 February 2012
amending Directive 98/8/EC of the European Parliament and of the Council to include copper (II) oxide, copper (II) hydroxide and basic copper carbonate as active substances in Annex I thereto
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (1), and in particular the second subparagraph of Article 16(2) thereof,
Whereas:
(1) |
Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC. That list includes copper (II) oxide, copper (II) hydroxide and basic copper carbonate for use in product type 8, wood preservatives, as defined in Annex V to that Directive. |
(2) |
Pursuant to Regulation (EC) No 1451/2007, copper (II) oxide, copper (II) hydroxide and basic copper carbonate have been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product type 8. |
(3) |
France was designated as rapporteur Member State and submitted the competent authority reports, together with recommendations, to the Commission in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007 on 10 May 2007 for copper (II) oxide, on 19 February 2008 for copper (II) hydroxide, and on 10 May 2007 and 19 February 2008 for basic copper carbonate. |
(4) |
The competent authority reports were reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the reviews were incorporated, within the Standing Committee on Biocidal Products on 22 September 2011, in an assessment report. |
(5) |
It appears from the evaluations that biocidal products used as wood preservatives and containing copper (II) oxide, copper (II) hydroxide or basic copper carbonate may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include copper (II) oxide, copper (II) hydroxide and basic copper carbonate in Annex I to that Directive. |
(6) |
Not all potential uses have been evaluated at Union level. It is therefore appropriate to require that Member States assess those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment and, when granting product authorisations, ensure that appropriate measures are taken or specific conditions imposed in order to reduce the identified risks to acceptable levels. |
(7) |
In view of the risks identified for human health, it is appropriate to require that safe operational procedures are established for products containing copper (II) oxide, copper (II) hydroxide or basic copper carbonate and authorised for industrial use, and that those products are used with appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that risks to industrial users can be reduced to an acceptable level by other means. |
(8) |
Copper (II) hydroxide and basic copper carbonate were also evaluated for application by dipping, and should, in view of the risks identified for human health, not be authorised for that use, unless data is submitted to demonstrate that the product will meet the requirements of Article 5 and Annex VI, if necessary by the application of appropriate mitigation measures. For copper (II) oxide, application by dipping was not assessed, and it follows from the requirement referred to in recital 6 that products cannot be authorised for such application unless the authorising Member State assesses it. |
(9) |
Unacceptable risks for the environment were identified in the case of wood treated with copper (II) oxide, copper (II) hydroxide or basic copper carbonate and used for outdoor constructions near or above water (the ‘bridge’ scenario in use class 3, as defined by OECD (3)). For basic copper carbonate and copper (II) oxide, unacceptable risks were also found for in-service use of treated wood in contact with fresh water (use class 4b as defined by OECD). It is therefore appropriate to require that products are not authorised for the treatment of wood intended for those uses, unless data is submitted demonstrating that the product will meet the requirements of both Article 5 of and Annex VI to Directive 98/8/EC, if necessary by the application of appropriate risk mitigation measures. For copper (II) hydroxide, wood in contact with fresh water was not assessed, and it follows from the requirement referred to in recital 6 above that products cannot be authorised for that use unless the authorising Member State assesses it. |
(10) |
In view of the risks identified for the aquatic and soil compartments, it is appropriate to require that freshly treated timber is stored after treatment under shelter or on impermeable hard standing, or both, and that any losses from the application of products used as wood preservatives and containing copper (II) oxide, copper (II) hydroxide or basic copper carbonate are collected for reuse or disposal. |
(11) |
The provisions of this Directive should be applied at the same time in all Member States in order to ensure equal treatment on the Union market of biocidal products containing the active substances copper (II) oxide, copper (II) hydroxide and basic copper carbonate, and also to facilitate the proper operation of the biocidal products market in general. |
(12) |
A reasonable period should be allowed to elapse before an active substance is included in Annex I to Directive 98/8/EC in order to permit Member States and interested parties to prepare themselves to meet the new requirements entailed and to ensure that applicants who have prepared dossiers can benefit fully from the 10-year period of data protection, which, in accordance with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from the date of inclusion. |
(13) |
After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC. |
(14) |
Directive 98/8/EC should therefore be amended accordingly. |
(15) |
The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Biocidal Products, |
HAS ADOPTED THIS DIRECTIVE:
Article 1
Annex I to Directive 98/8/EC is amended in accordance with the Annex to this Directive.
Article 2
1. Member States shall adopt and publish, by 31 January 2013 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.
They shall apply those provisions from 1 February 2014.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Article 3
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
Article 4
This Directive is addressed to the Member States.
Done at Brussels, 9 February 2012.
For the Commission
The President
José Manuel BARROSO
(1) OJ L 123, 24.4.1998, p. 1.
(2) OJ L 325, 11.12.2007, p. 3.
(3) OECD series on emission scenario documents, Number 2, Emission Scenario Document for Wood Preservatives, part 2, p. 64.
ANNEX
In Annex I to Directive 98/8/EC, the following entries are added:
No |
Common name |
IUPAC name, identification numbers |
Minimum purity of the active substance in the biocidal product as placed on the market |
Date of inclusion |
Deadline for compliance with Article 16(3) (except for products containing more than one active substance, for which the deadline to comply with Article 16(3) shall be the one set out in the last of the inclusion decisions relating to its active substances) |
Expiry date of inclusion |
Product type |
Specific provisions (*1) |
||||||||
‘50 |
Copper hydroxide |
Copper (II) hydroxide EC No: 243-815-9 CAS No: 20427-59-2 |
965 g/kg |
1 February 2014 |
31 January 2016 |
31 January 2024 |
8 |
When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, where relevant for the particular product, those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment. Member States shall ensure that authorisations are subject to the following conditions:
|
||||||||
51 |
Copper (II) oxide |
Copper (II) oxide EC No: 215-269-1 CAS No: 1317-38-0 |
976 g/kg |
1 February 2014 |
31 January 2016 |
31 January 2024 |
8 |
When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, where relevant for the particular product, those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment. Member States shall ensure that authorisations are subject to the following conditions:
|
||||||||
52 |
Basic copper carbonate |
Copper(II) carbonate-copper(II) hydroxide (1:1) EC No: 235-113-6 CAS No: 12069-69-1 |
957 g/kg |
1 February 2014 |
31 January 2016 |
31 January 2024 |
8 |
When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, where relevant for the particular product, those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment. Member States shall ensure that authorisations are subject to the following conditions:
|
(*1) For the implementation of the common principles of Annex VI, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm
10.2.2012 |
EN |
Official Journal of the European Union |
L 37/65 |
COMMISSION DIRECTIVE 2012/3/EU
of 9 February 2012
amending Directive 98/8/EC of the European Parliament and of the Council to include bendiocarb as an active substance in Annex I thereto
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (1), and in particular the second subparagraph of Article 16(2) thereof,
Whereas:
(1) |
Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC. That list includes bendiocarb. |
(2) |
Pursuant to Regulation (EC) No 1451/2007, bendiocarb has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product type 18, insecticides, acaricides and products to control other arthropods, as defined in Annex V to that Directive. |
(3) |
The United Kingdom was designated as rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 1 April 2008 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007. |
(4) |
The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 22 September 2011, in an assessment report. |
(5) |
It appears from the evaluations that biocidal products used as insecticides, acaricides and products to control other arthropods and containing bendiocarb may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include bendiocarb in Annex I to that Directive. |
(6) |
Not all potential uses have been evaluated at Union level. For example, the assessment only considers professional use, and does not cover direct application to soil or application on food or feedstuff or on surfaces that will come in contact with food or feedstuff. It is therefore appropriate that Member States assess those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment and, when granting product authorisations, ensure that appropriate measures are taken or specific conditions imposed in order to reduce the identified risks to acceptable levels. |
(7) |
In view of the risks identified for the aquatic environment due to wet cleaning of treated surfaces, resulting in emissions of a certain scale to surface waters, it is appropriate to require that products not be authorised for use on surfaces that are prone to frequent wet cleaning, other than crack and crevice or spot treatments, unless data are submitted demonstrating that the product will meet the requirements of both Article 5 of and Annex VI to Directive 98/8/EC, if necessary by the application of appropriate risk mitigation measures. |
(8) |
In view of the risks identified for human health, it is appropriate to require that products authorised for industrial or professional use must be used with appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that risks to industrial or professional users can be reduced to an acceptable level by other means. |
(9) |
In view of the potential risk to honey bees, it is appropriate to require that, where relevant, action is taken to prevent foraging bees gaining access to treated nests by removing the combs or blocking the nest entrances. |
(10) |
The provisions of this Directive should be applied at the same time in all Member States in order to ensure equal treatment on the Union market of biocidal products containing the active substance bendiocarb and also to facilitate the proper operation of the biocidal products market in general. |
(11) |
A reasonable period should be allowed to elapse before an active substance is included in Annex I to Directive 98/8/EC, in order to permit Member States and interested parties to prepare themselves to meet the new requirements entailed and to ensure that applicants who have prepared dossiers can benefit fully from the 10-year period of data protection, which, in accordance with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from the date of inclusion. |
(12) |
After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC. |
(13) |
Directive 98/8/EC should therefore be amended accordingly. |
(14) |
The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Biocidal Products, |
HAS ADOPTED THIS DIRECTIVE:
Article 1
Annex I to Directive 98/8/EC is amended in accordance with the Annex to this Directive.
Article 2
1. Member States shall adopt and publish, by 31 January 2013 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive.
They shall apply those provisions from 1 February 2014.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Article 3
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
Article 4
This Directive is addressed to the Member States.
Done at Brussels, 9 February 2012.
For the Commission
The President
José Manuel BARROSO
ANNEX
In Annex I to Directive 98/8/EC, the following entry is added:
No |
Common Name |
IUPAC Name Identification Numbers |
Minimum purity of the active substance in the biocidal product as placed on the market |
Date of inclusion |
Deadline for compliance with Article 16(3) (except for products containing more than one active substance, for which the deadline to comply with Article 16(3) shall be the one set out in the last of the inclusion decisions relating to its active substances) |
Expiry date of inclusion |
Product type |
Specific provisions (*1) |
||||||
‘53 |
bendiocarb |
2,2-dimethyl-1,3-benzodioxol-4-yl methylcarbamate CAS-No: 22781-23-3 EC No: 245-216-8 |
970 g/kg |
1 February 2014 |
31 January 2016 |
31 January 2024 |
18 |
The Union level risk assessment did not address all potential uses, but concerned, for example, application by professionals only, and excluded contact with feed or food and direct application on soil. When assessing the application for authorisation of a product in accordance with Article 5 and Annex VI, Member States shall assess, where relevant for the particular product, those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment. Member States shall ensure that authorisations are subject to the following conditions:
|
(*1) For the implementation of the common principles of Annex VI, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm
Corrigenda
10.2.2012 |
EN |
Official Journal of the European Union |
L 37/68 |
Corrigendum to Council Regulation (EU) No 43/2012 of 17 January 2012 fixing for 2012 the fishing opportunities available to EU vessels for certain fish stocks and groups of fish stocks which are not subject to international negotiations or agreements
( Official Journal of the European Union L 25 of 27 January 2012 )
On page 1, recital 4:
for:
‘(4) |
In order to ensure uniform conditions for the implementation concerning the granting individual Member State …’, |
read:
‘(4) |
In order to ensure uniform conditions for the implementation concerning the granting to an individual Member State …’. |