(1)

Regulation (EU) No 1151/2012 entered into force on 3 January 2013. It repealed and replaced Council Regulation (EC) No 510/2006 of 20 March 2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs (2).

(2)

Pursuant to Article 6(2) of Regulation (EC) No 510/2006, Germany’s application to register the name ‘Spargel aus Franken’ or ‘Fränkischer Spargel’ or ‘Franken-Spargel’ was published in the Official Journal of the European Union (3).

(3)

As no statement of objection under Article 7 of Regulation (EC) No 510/2006 has been received by the Commission, that name should therefore be entered in the register,

(1)

Regulation (EU) No 1151/2012 entered into force on 3 January 2013. It repealed and replaced Council Regulation (EC) No 510/2006 of 20 March 2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs (2).

(2)

Pursuant to Article 6(2) of Regulation (EC) No 510/2006, Italy’s application to register the name ‘Mela Rossa Cuneo’ was published in the Official Journal of the European Union (3).

(3)

As no statement of objection under Article 7 of Regulation (EC) No 510/2006 has been received by the Commission, that name should therefore be entered in the register,

(1)

Regulation (EU) No 1151/2012 entered into force on 3 January 2013. It repealed and replaced Council Regulation (EC) No 510/2006 of 20 March 2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs (2).

(2)

Pursuant to Article 6(2) of Regulation (EC) No 510/2006, Finland’s application to register the name ‘Kitkan viisas’ was published in the Official Journal of the European Union (3).

(3)

As no statement of objection under Article 7 of Regulation (EC) No 510/2006 has been received by the Commission, that name should therefore be entered in the register,

(1)

Regulation (EU) No 1151/2012 entered into force on 3 January 2013. It repealed and replaced Council Regulation (EC) No 510/2006 of 20 March 2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs (2).

(2)

Pursuant to Article 6(2) of Regulation (EC) No 510/2006, Italy’s application to register the name ‘Ficodindia di San Cono’ was published in the Official Journal of the European Union (3).

(3)

As no statement of objection under Article 7 of Regulation (EC) No 510/2006 has been received by the Commission, that name should therefore be entered in the register,

(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,

(1)

A risk assessment report on 4-methylamphetamine was drawn up on the basis of Article 6 of Decision 2005/387/JHA by a special session of the extended Scientific Committee of the European Monitoring Centre for Drugs and Drug Addiction, and was subsequently received by the Commission on 29 November 2012.

(2)

4-methylamphetamine is a synthetic ring-methylated derivative of amphetamine which has predominantly been seized in powder and paste form in samples containing amphetamine and caffeine, but which has also appeared in tablet and liquid form. It has emerged on the illicit amphetamine market where it is sold and used as the controlled drug, amphetamine. There has been one report of the substance being detected in a commercial product sold on the internet. The main chemical precursor for the synthesis of 4-methylamphetamine is 4-methylbenzyl methyl ketone (4-methyl-BMK), which appears to be commercially available on the internet and is not controlled under the 1988 United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances.

(3)

The specific physical effects of 4-methylamphetamine have been rarely reported by users, since users are typically unaware that they have taken the substance. However, the few reports that are available suggest that it has stimulant-type effects. Limited data available relating to humans suggest that the adverse effects of 4-methylamphetamine include hyperthermia, hypertension, anorexia, nausea, perspiration, gastric distress, coughing, vomiting, headache, palpitations, insomnia, paranoia, anxiety and depression. Current data is not sufficient to determine the relative dependence-producing potential of the substance.

(4)

According to the limited data sources available, the acute toxicity of 4-methylamphetamine is similar to that of other stimulants. Certain evidence suggests that a combination of 4-methylamphetamine with other substances, including amphetamine and caffeine, may result in a higher risk of overall enhanced toxicity.

(5)

There have been a total of 21 fatalities registered in four Member States where 4-methylamphetamine alone, or in combination with one or more substances, especially amphetamine, has been detected in post-mortem samples. While it is not possible to determine with certainty from the information available the role of 4-methylamphetamine in those fatalities, in some cases the substance was the predominant drug detected, with levels comparable to those found in certain cases of death caused by the consumption of amphetamine.

(6)

4-methylamphetamine has been detected in 15 Member States, while one Member State has reported the manufacture of the substance on its territory. Prevalence specific to 4-methylamphetamine is difficult to estimate. There is no information on specific demand for the substance from user groups and it is not commercially marketed through internet shops.

(7)

The information available suggests that 4-methylamphetamine is produced and distributed by the same organised crime groups that are involved in the manufacture and trafficking of amphetamine.

(8)

4-methylamphetamine has no known, established or acknowledged medical value or use in the Union and there is no marketing authorisation for the substance in the Union. Apart from its use as an analytical reference standard and in scientific research, there is no indication that it may be used for any other legitimate purpose.

(9)

4-methylamphetamine is not currently under assessment and has not been under assessment by the United Nations system. Eight Member States control the substance under drug control legislation by virtue of their obligations under the 1971 United Nations Convention on Psychotropic Substances. Two other Member States apply the generic definition of phenethylamine in their national legislation to the product while one Member State controls it under its medicines legislation.

(10)

The risk assessment report reveals that there is limited scientific evidence available on the characteristics and risks of 4-methylamphetamine and points out that further studies are required on the overall health and social risks associated with the substance. However, the evidence available provides sufficient grounds for subjecting 4-methylamphetamine to control measures across the Union. As a result of the health risks it poses, as documented in its detection in several reported fatalities, especially when used in combination with other substances; its strong resemblance in terms of appearance and effects with amphetamine; the fact that users may unknowingly consume the substance and its limited medical value or use, 4-methylamphetamine should be subjected to control measures across the Union.

(11)

Since 10 Member States already control 4-methylamphetamine, subjecting it to control measures across the Union may help avoid problems in cross-border law enforcement and judicial cooperation.

(12)

Union-wide control measures may also help prevent 4-methylamphetamine developing as an alternative to amphetamine in the illicit drug markets,

(1)

Annex I to Directive 98/8/EC contains the list of active substances approved at Union level for inclusion in biocidal products. Commission Directive 2009/87/EC of 29 July 2009 amending Directive 98/8/EC of the European Parliament and of the Council to include indoxacarb as an active substance in Annex I thereto (2) added the active substance indoxacarb to products belonging to product-type 18: Insecticides, acaricides and products to control other arthropods, as defined in Annex V to Directive 98/8/EC.

(2)

Directive 2009/87/EC requires Member States to assess, for the purpose of granting product authorisation, any relevant use scenarios that have not been representatively addressed at the Union level risk assessment.

(3)

The company DuPont de Nemours (Deutschland) GmbH (‘the applicant’) submitted an application to the United Kingdom for authorisation of a product containing indoxacarb (‘the contested product’) in accordance with Article 8 of Directive 98/8/EC. The names and reference numbers of the contested product in the Register for Biocidal Products (‘R4BP’) are indicated in the Annex to this Decision.

(4)

On 28 October 2011, the United Kingdom authorised the contested product for the control of ants. According to that authorisation, the product may be applied only in and around residential homes, industrial facilities, offices, warehouses, commercial kitchens, hospitals, schools, nursing homes, hotels, buses, trains, aircraft, retail and commercial establishments. That authorisation further provides that the application of the contested product to food or feed areas of food or feed handling establishments may be made only as a crack and crevice treatment. The authorisation set out that the product had to be labelled with the following instruction: ‘Do not apply to areas where food/feed, food utensils or food processing surfaces may come into contact with, or be contaminated by the product’.

(5)

On 21 December 2011, the applicant submitted a complete application to Germany for mutual recognition of the first authorisation in respect of the contested product.

(6)

On 23 April 2012, Germany notified the Commission, the other Member States and the applicant of its proposal to restrict the first authorisation in accordance with Article 4(4) of Directive 98/8/EC by excluding food protection from the authorised intended uses of the contested product.

(7)

As justification for the notification, Germany submitted that products used for food protection are covered, for this purpose, by Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (3), and are hence excluded from the scope of Directive 98/8/EC if the protected food consists of plants or plant products within the meaning of Article 3(5) and (6) of Regulation (EC) No 1107/2009.

(8)

The Commission invited the other Member States and the applicant to submit comments to the notification in writing within 90 days in accordance with Article 27(1) of Directive 98/8/EC. Comments were submitted within that deadline by the United Kingdom, France and Spain. The notification was also discussed between Commission representatives, representatives of Member States’ Competent Authorities for biocidal products in the meeting of the Product Authorisation and Mutual Recognition Facilitation Group of 22-23 May 2012, where the applicant was present.

(9)

As it is undisputed that the contested product is covered by the definition of a biocidal product in Article 2(1)(a) of Directive 98/8/EC, it merely should be examined whether the product is nevertheless excluded from the scope of Directive 98/8/EC by virtue of Article 1(2)(r) of that Directive for the purpose of certain uses, in which case those particular uses would require an additional authorisation in accordance with Regulation (EC) No 1107/2009.

(10)

It follows from Article 2(1)(a) of Regulation (EC) No 1107/2009 that that Regulation does not apply to products whose main purpose is considered to be hygiene rather than the protection of plants or plant products.

(11)

The contested product is, inter alia, intended for use as an insecticide against ants in commercial kitchens. One of the intentions of such use can be the protection of plant products as defined in Article 3(6) of Regulation (EC) No 1107/2009, which can include food.

(12)

The contested product is also intended for a large number of other use areas, where it will not serve the purpose of protecting food consisting of plants or plant products. Furthermore, even the application in commercial kitchens cannot be considered as primarily intended for plant product protection: First, the contested product must not be directly applied on food or indirectly come into contact with food through application on empty structures. Second, most products handled in a commercial kitchen are not plant products (4). Third, Member States other than Germany have informed the Commission that the contested product is used in kitchens to comply with the general hygiene requirements according to Annex II to Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (5) for all stages of production, processing and distribution.

(13)

As the main purpose of the contested product is hygiene rather than the protection of plants or plant products, the product is not excluded from the scope of Directive 98/8/EC by virtue of Article 1(2)(r) of that Directive for the purpose of its use in commercial kitchens. The Commission therefore considers that the restriction requested by Germany cannot be justified on the grounds put forward.

(14)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Biocidal Products,