11.12.2008   

EN

Official Journal of the European Union

L 333/1

11.12.2008   

EN

Official Journal of the European Union

L 333/3

(1)

Pursuant to the first subparagraph of Article 6(2) of Regulation (EC) No 510/2006 and in accordance with Article 17(2) thereof, Spain’s application to register the name ‘San Simón da Costa’, France’s application to register the name ‘Ail blanc de Lomagne’ and Austria’s application to register the name ‘Steirischer Kren’ were published in the Official Journal of the European Union  (2).

(2)

As no objection under Article 7 of Regulation (EC) No 510/2006 has been received by the Commission, these names should be entered in the Register,

11.12.2008   

EN

Official Journal of the European Union

L 333/5

(1)

The Portuguese medical device authority Infarmed has, by letter of 29 July 2005 (2) addressed to the Italian company Medical Biological Service SRL (hereafter MBS), forbidden the marketing of their HIV in-vitro diagnostic test kit ‘HIV 1 & 2 Ab’ (hereafter the HIV test). Infarmed also obliged the Portuguese distributor Prestifarma Lda to recall the product on behalf of MBS.

(2)

By letter of 1 September 2005 (3) Infarmed notified these measures under Article 13 of Directive 98/79/EC. As justification for their measure Portugal referred to the German Paul-Ehrlich-Institut’s health surveillance report ‘NCAR DE-2005-07-30’ (PEI Case No PEI0026/05). A subsequent exchange of letters clarified that the NCAR reference was misquoted and that the correct NCAR report number was DE-2005-07-07-30 and that this report is identical to the NCAR report DE-2005-07-27-30.

(3)

The NCAR report DE-2005-07-07-30 states that, shortly after an HIV infection, the HIV test needs 10 to 18 days more than comparable tests to detect the infection (low early sero-conversion sensitivity). For the same reason, the Slovak Medical University had, in its test report of 28 October 2004 (4), recommended the Slovak notified body EVPÚ not to certify the HIV test. The test did thus not fulfil the requirement of being conform to the ‘state of the art’ in the meaning of Annex I (Essential requirements) section A.2 of Directive 98/79/EC and section 3.1.8, third sentence, of the Common technical specifications for in-vitro diagnostic medical devices annexed to Commission Decision 2002/364/EC of 7 May 2002 on common technical specifications for in-vitro diagnostic medical devices (5).

(4)

Moreover, as stated by the Paul-Ehrlich-Institut in its letter to the German Ministry of Health of 12 December 2005 (6), the documentation made available by the manufacturer shows that the HIV test did not detect all true positive samples, as required by 3.1.8, first sentence, of the Common technical specifications. This failure has never been explained by the manufacturer or his notified body as required by paragraph 3.1.5 of the Common technical specifications. Thus the HIV test does not fulfil sections 3.1.8, first sentence, and 3.1.5 of the Common technical specifications.

(5)

MBS modified the HIV test after taking note of the NCAR report DE-2005-07-07-30. However, the modification did not improve the early sero-conversion sensitivity of the HIV test, as stated by the Paul-Ehrlich-Institut later in a report of 23 August 2007 (7). As stated on page 10 of this report, the modified test also fails to detect samples already confirmed as true positive by Western blot or immunoblot assays.

(6)

The Commission consulted the Member States by letter of 22 March 2007 (D(2007) 7800), the involved notified bodies and institutes by letter of 21 March 2007 (D(2007) 7817), and MBS by letter of 11 June 2007 (D(2007) 16597). It furthermore consulted experts in the field of in-vitro diagnostic medical devices on various occasions and, inter alia, in a meeting on 31 January 2008.

(7)

Article 13 of Directive 98/79/EC (Particular health monitoring measure) has wider conditions than Article 8 (Safeguard clause) of this Directive. Article 13 of Directive 98/79/EC does not require the same level of certainty of the acting authority with regard to the existence of a risk.

(8)

The analysis of the initial notification and of the later correspondence of Infarmed and the consultation of the parties concerned have shown that that it can be ascertained that the device under examination, when correctly maintained and used for its intended purpose, may compromise the health and/or the safety of patients, users or other persons, in the meaning of Article 8 of Directive 98/79/EC, as the essential requirement of being ‘state of the art’ is not met.

(9)

As the test is slower and less reliable than other devices, it will detect less HIV infections than the other devices and may delay the start of an adequate anti-retroviral therapy. The test could also contribute to an increased risk of missing HIV infected blood donors. It also compromises health in as much as its late and poor detection of the HIV infection may increase the risk of transmission to third persons, for instance by sexual intercourse.

(10)

According to the European Court of Justice (8) the view given by the European Commission in accordance with Article 8.2 of Directive 98/79/EC binds the Member State which has taken measures. Accordingly, this legal act is to be qualified as a decision,

11.12.2008   

EN

Official Journal of the European Union

L 333/7

(1)

On 31 October 2006, Monsanto Europe S.A. submitted to the competent authority of the Netherlands an application, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from MON89788 soybean (the application).

(2)

The application also covers the placing on the market of other products containing or consisting of MON89788 soybean for the same uses as any other soybean with the exception of cultivation. Therefore, in accordance with Articles 5(5) and 17(5) of Regulation (EC) No 1829/2003, it includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (2) and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC.

(3)

On 11 July 2008, the European Food Safety Authority (EFSA) gave a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003 and concluded that it is unlikely that the placing on the market of the products containing, consisting of, or produced from MON89788 soybean as described in the application (the products) will have any adverse effects on human or animal health or the environment in the context of their intended uses (3). In its opinion, EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Articles 6(4) and 18(4) of that Regulation.

(4)

In its opinion, EFSA also concluded that the environmental monitoring plan, consisting of a general surveillance plan, submitted by the applicant is in line with the intended use of the products.

(5)

Taking into account those considerations, authorisation should be granted for the products.

(6)

A unique identifier should be assigned to each GMO as provided for in Commission Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms (4).

(7)

On the basis of the EFSA opinion, no specific labelling requirements other than those provided for in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, appear to be necessary for foods, food ingredients and feed containing, consisting of, or produced from MON89788 soybean. However, in order to ensure the use of the products within the limits of the authorisation provided for by this Decision, the labelling of feed containing or consisting of the GMO and products other than food and feed containing or consisting of the GMO for which authorisation is requested should be complemented by a clear indication that the products in question must not be used for cultivation.

(8)

Similarly, the EFSA opinion does not justify the imposition of specific conditions or restrictions for the placing on the market and/or specific conditions or restrictions for the use and handling, including post-market monitoring requirements, or of specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in point (e) of Articles 6(5) and 18(5) of Regulation (EC) No 1829/2003.

(9)

All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed, as provided for in Regulation (EC) No 1829/2003.

(10)

Article 4(6) of Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC (5), lays down labelling requirements for products consisting of, or containing GMOs.

(11)

This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Articles 9(1) and 15(2)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council of 15 July 2003 on transboundary movements of genetically modified organisms (6).

(12)

The applicant has been consulted on the measures provided for in this Decision.

(13)

The Standing Committee on the Food Chain and Animal Health has not delivered an opinion within the time limit laid down by its Chairman.

(14)

At its meeting on 19 November 2008, the Council was unable to reach a decision by qualified majority either for or against the proposal. The Council indicated that its proceedings on this file were concluded. It is accordingly for the Commission to adopt the measures,

(a)

foods and food ingredients containing, consisting of, or produced from MON-89788-1 soybean;

(b)

feed containing, consisting of, or produced from MON-89788-1 soybean;

(c)

products other than food and feed containing or consisting of MON-89788-1 soybean for the same uses as any other soybean with the exception of cultivation.

11.12.2008   

EN

Official Journal of the European Union

L 333/11

(1)

Article 8(2) of Directive 91/414/EEC provides that a Member State may, during a period of 12 years following the notification of that Directive, authorise the placing on the market of plant protection products containing active substances not listed in Annex I to that Directive that are already on the market two years after the date of notification, while those substances are gradually being examined within the framework of a programme of work.

(2)

Commission Regulations (EC) No 451/2000 (2) and (EC) No 1490/2002 (3) lay down the detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list includes the substances enumerated in the Annex to this Decision.

(3)

Within two months from receipt of the draft assessment report the notifiers concerned voluntarily withdrew, in accordance with Article 11e of Regulation (EC) No 1490/2002, their support for the inclusion of those substances.

(4)

The Commission has examined the draft assessment reports, the recommendations from the rapporteur Member States and the comments from other Member States and has come to the conclusion that Articles 11b and 11f do not apply. Consequently, Article 11e applies.

(5)

The substances listed in the Annex to this Decision should therefore not be included in Annex I to Directive 91/414/EEC.

(6)

As the non-inclusion of these substances is not based on the presence of clear indications of harmful effects as laid down in Annex VI to Regulation (EC) No 1490/2002, Member States should have the possibility to maintain authorisations until 31 December 2010, in accordance with Article 12(3) of Regulation (EC) No 1490/2002.

(7)

Any period of grace granted by a Member State for the disposal, storage, placing on the market and use of existing stocks of plant protection products containing the listed substances should be limited to 12 months in order to allow existing stocks to be used in one further growing season.

(8)

This Decision does not prejudice the submission of a new application under Article 6(2) of Directive 91/414/EEC and Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Council Directive 91/414/EEC as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but have not been included into its Annex I (4) in accordance with the accelerated procedure provided for in Articles 13 to 22 of that Regulation.

(9)

That procedure allows notifiers whose substance has not been included based on their withdrawal, to make a new application submitting only the additional data necessary to address the specific issues that led to the adoption of the non-inclusion Decision. The notifier has received the draft assessment report which identifies those data.

(10)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

11.12.2008   

EN

Official Journal of the European Union

L 333/15

(1)

Community reference laboratories in the food and feed control area may be granted a Community financial contribution in accordance with Article 28 of Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field (2).

(2)

The Joint Research Centre of the European Commission in Ispra, Italy is listed in Annex VII to Regulation (EC) No 882/2004 as the Community reference laboratory for material intended to come into contact with foodstuffs and for genetically modified organisms. The Joint Research Centre of the European Commission in Geel, Belgium is listed in Annex VII to Regulation (EC) No 882/2004 as the Community reference laboratory for heavy metal in feed and food, for mycotoxins and for polycyclic aromatic hydrocarbons (PAH).

(3)

The Joint Research Centre and the Directorate-General for Health and Consumers are both services of the Commission and their relationship is laid down in an annual administrative arrangement supported by a work programme and its budget.

(4)

The work programmes and corresponding budget estimates of the Community reference laboratories within the Joint Research Centre for the year 2009 have been assessed.

(5)

Accordingly, a Community financial contribution should be granted for certain activities of the Joint Research Centre of the European Commission in Geel, Belgium and Ispra, Italy, as provided for in Regulation (EC) No 882/2004. The Community’s financial contribution should be at the rate of 100 % of eligible costs as defined in Commission Regulation (EC) No 1754/2006 (3).

(6)

In accordance with Article 3(2)(a) of Council Regulation (EC) No 1290/2005 of 21 June 2005 on the financing of the common agricultural policy (4), animal disease eradication and control programmes (veterinary measures) shall be financed from the European Agricultural Guarantee Fund (EAGF). Furthermore, Article 13, second paragraph of that Regulation foresees that in duly justified exceptional cases, for measures and programmes covered by Decision 90/424/EEC, expenditure relating to administrative and personnel costs incurred by Member States and beneficiaries of aid from the EAGF shall be borne by the Fund. For financial control purposes, Articles 9, 36 and 37 of Regulation (EC) No 1290/2005 are to apply.

(7)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

1.

the activities related to material in contact with foodstuffs; this contribution shall not exceed EUR 180 003;

2.

the organisation of the workshops by that laboratory, concerning the activities referred to in point 1; this contribution shall not exceed EUR 75 947;

3.

the activities related to GMOs; this contribution shall not exceed EUR 13 388;

4.

the organisation of the workshops by that laboratory, concerning the activities referred to in point 3; this contribution shall not exceed EUR 61 440.

1.

the activities related to heavy metals in feed and food; this contribution shall not exceed EUR 250 000;

2.

the organisation of the workshops by that laboratory, concerning the activities referred to in point 1; this contribution shall not exceed EUR 25 000;

3.

the activities related to mycotoxins; this contribution shall not exceed EUR 230 000;

4.

the organisation of the workshops by that laboratory, concerning the activities referred to in point 3; this contribution shall not exceed EUR 22 000;

5.

the activities related to polycyclic aromatic hydrocarbons (PAH); this contribution shall not exceed EUR 232 000;

6.

the organisation of the workshops by that laboratory, concerning the activities referred to in point 5; this contribution shall not exceed EUR 22 000.

—

for food contact materials: Joint Research Centre, Institute for Health and Consumer Protection, Physical and Chemical Exposures Unit, TP 260, Via E. Fermi, 1, 21020 Ispra (Italy),

—

for genetically modified organisms: Joint Research Centre, Institute for Health and Consumer Protection, Biotechnology and GMOs Unit, Via E. Fermi, 1, 21020 Ispra (Italy),

—

for heavy metals: Joint Research Centre, Retieseweg 111, 2440 Geel (Belgium),

—

for mycotoxins: Joint Research Centre, Retieseweg 111, 2440 Geel (Belgium),

—

for PAHs: Joint Research Centre, Retieseweg 111, 2440 Geel (Belgium).

11.12.2008   

EN

Official Journal of the European Union

L 333/s3