20.1.2016

Official Journal of the European Union

L 13/1

Information concerning the entry into force of the Agreement for scientific and technological cooperation between the European Union and the Faroe Islands associating the Faroe Islands to Horizon 2020 — the Framework Programme for Research and Innovation (2014-2020)

The Agreement for scientific and technological cooperation between the European Union and the Faroe Islands associating the Faroe Islands to Horizon 2020 — the Framework Programme for Research and Innovation (2014-2020), signed on 17 December 2014 (1), has, in accordance with Article 5(2) thereof, entered into force on 5 January 2016.

(1) OJ L 35, 11.2.2015, p. 3.

20.1.2016

Official Journal of the European Union

L 13/2

COUNCIL REGULATION (Euratom) 2016/52

of 15 January 2016

laying down maximum permitted levels of radioactive contamination of food and feed following a nuclear accident or any other case of radiological emergency, and repealing Regulation (Euratom) No 3954/87 and Commission Regulations (Euratom) No 944/89 and (Euratom) No 770/90

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Atomic Energy Community, and in particular Articles 31 and 32 thereof,

Having regard to the proposal from the European Commission, drawn up after obtaining the opinion of the group of persons appointed by the Scientific and Technical Committee from among scientific experts in the Member States,

Having regard to the opinion of the European Parliament (1),

Having regard to the opinion of the European Economic and Social Committee (2),

Whereas:

(1)	Council Directive 2013/59/Euratom (3) lays down basic safety standards for the protection against the dangers arising from exposure to ionising radiation.

(2)

Following the accident at the Chernobyl nuclear power station on 26 April 1986, considerable quantities of radioactive materials were released into the atmosphere, contaminating food and feed in several European countries to levels that were significant from the point of view of health. Measures were adopted to ensure that certain agricultural products are only introduced into the Union in accordance with the common arrangements which safeguard the health of the population while maintaining the unified nature of the market and avoiding deflections of trade.

(3)

Council Regulation (Euratom) No 3954/87 (4) lays down maximum permitted levels of radioactive contamination to be applied following a nuclear accident or any other case of radiological emergency which is likely to lead or has led to significant radioactive contamination of food and feed. Those maximum permitted levels are still in line with the latest scientific advice as presently available internationally. The basis for the establishment of the maximum permitted levels set out in this Regulation has been reviewed and described in the Commission Radiation Protection Publication 105 (EU Food Restriction Criteria for Application after an Accident). In particular, those levels are based on a reference level of 1 mSv per year for the increment in individual effective dose by ingestion and on the assumption that 10 % of food consumed annually is contaminated. However, different assumptions apply to infants under 1 year.

(4)

Following the accident at the Fukushima nuclear power station on 11 March 2011, the Commission was informed that radionuclide levels in certain food products originating in Japan exceeded the action levels in food applicable in Japan. Such contamination could constitute a threat to public and animal health in the Union and therefore measures were adopted imposing special conditions governing the import of food and feed originating in or consigned from Japan, in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, established by Regulation (EC) No 178/2002 of the European Parliament and of the Council (5).

(5)

There is a need to set up a system allowing the Community, following a nuclear accident or any other case of radiological emergency which is likely to lead or has led to a significant radioactive contamination of food and feed, to establish maximum permitted levels of radioactive contamination regarding products to be placed on the market in order to protect the population.

(6)

Like other food, drinking water is ingested directly or indirectly and therefore plays a role in the consumer's overall exposure to radioactive substances. With regard to radioactive substances, quality control of water intended for human consumption is already provided for in Council Directive 2013/51/Euratom (6), with the exclusion of mineral waters and waters which are medicinal products. This Regulation should apply to food, minor food and feed which could be placed on the market following a nuclear accident or any other case of radiological emergency, and not to water intended for human consumption for which Directive 2013/51/Euratom applies. However, in the case of a radiological emergency, Member States are free to choose to refer to the maximum levels for liquid food set out in this Regulation in order to manage the use of water intended for human consumption.

(7)	Maximum permitted levels of radioactive contamination should apply to food and feed originating in the Union or imported from third countries on the basis of the location and circumstances of the nuclear accident or other radiological emergency.

(8)	The Commission is to be informed of a nuclear accident or of unusually high levels of radioactivity under Council Decision 87/600/Euratom (7) or under the International Atomic Energy Agency (IAEA) Convention on Early Notification of a Nuclear Accident of 26 September 1986.

(9)

In order to take into account that diets of infants during their first 6 months may vary significantly and that there are uncertainties in the metabolism of infants during the second 6-month period as well, it is appropriate to extend the application of lower maximum permitted levels for foods for infants to the first 12 months.

(10)

In order to facilitate the adaptation of applicable maximum permitted levels, in particular with regard to the circumstances of the nuclear accident or other radiological emergency, procedures for reviewing the implementing Regulations should include the consultation by the Commission of the group of experts referred to in Article 31 of the Treaty.

(11)	In order to ensure that food and feed exceeding the applicable maximum permitted levels are not placed on the Community market, compliance with these levels should be the subject of appropriate checks.

(12)

In order to ensure uniform conditions for the implementation of this Regulation as regards rendering applicable maximum permitted levels, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (8) which is to apply for the purpose of this Regulation notwithstanding the fact that it does not refer explicitly to Article 106a of the Treaty.

(13)

The Commission should be assisted by the Standing Committee on Plants, Animals, Food and Feed. Member States should ensure that, where draft implementing acts based on this Regulation are discussed by that Committee, their representatives have, or can rely on, adequate expertise in radiological protection.

(14)	The examination procedure should be used for the adoption of acts rendering applicable maximum permitted levels of radioactive contamination of food and feed.

(15)	The Commission should adopt immediately applicable implementing acts where, in duly justified cases relating to certain radiological emergencies which are likely to lead or have led to a significant radioactive contamination of food and feed, imperative grounds of urgency so require.

(16)

This Regulation should constitute a lex specialis for the procedure to adopt and subsequently amend implementing Regulations laying down applicable maximum permitted levels of radioactive contamination following a case of radiological emergency. Where it is evident that food or feed originating in the Union or imported from a third country is likely to constitute a serious risk to human health, animal health or the environment and that such risk cannot be contained satisfactorily by means of measures taken by the Member State or Member States concerned, the Commission is allowed to adopt additional emergency measures pursuant to Regulation (EC) No 178/2002. The Commission should ensure that this Regulation and Regulation (EC) No 178/2002 are implemented in a harmonised way. Where possible, applicable maximum permitted levels and additional emergency measures should be integrated in a single implementing Regulation based on this Regulation and Regulation (EC) No 178/2002.

(17)	Furthermore, general rules for the performance of official controls to verify compliance with rules aiming, inter alia, to prevent, eliminate or reduce to acceptable levels risks to humans and animals are laid down in Regulation (EC) No 882/2004 of the European Parliament and of the Council (9).

(18)

When preparing or reviewing implementing Regulations, the Commission should take into account, inter alia, the following circumstances: location, nature and extent of the nuclear accident or other radiological emergency within or outside the Community; nature, extent and spread of the identified or projected release of radioactive substances in air, water and soil and in food and feed within or outside the Community; radiological risks of the identified or potential radioactive contamination of food and feed and the resulting radiation doses; type and quantity of the contaminated food and feed which might be brought onto the market in the Community; maximum permitted levels for contaminated food and feed set in third countries; importance of this food and feed for providing the population with an adequate food supply; consumer expectations regarding the safety of food and possible changes to consumers' eating habits as a result of a radiological emergency.

(19)

In duly justified cases, any Member State should have the possibility to request to be allowed to derogate temporarily from the maximum permitted levels of radioactive contamination in respect of specified food or feed consumed on its territory. Implementing Regulations should specify the food and feed to which the derogations apply, the types of radionuclides concerned, as well as the geographical scope and duration of the derogations,

HAS ADOPTED THIS REGULATION:

Article 1

Subject matter

This Regulation lays down the maximum permitted levels of radioactive contamination of:

(a)	food, as set out in Annex I;

(b)	minor food, as set out in Annex II; and

(c)	feed, as set out in Annex III,

which may be placed on the market following a nuclear accident or any other case of radiological emergency which is likely to lead to or has led to significant radioactive contamination of food and feed.

This Regulation also lays down the procedure to adopt or subsequently amend implementing Regulations laying down the applicable maximum permitted levels.

Article 2

Definitions

For the purposes of this Regulation, the following definitions apply:

(1)

‘food’ means any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans.

‘Food’ includes drink, chewing gum and any substance intentionally incorporated into the food during its manufacture, preparation or treatment.

‘Food’ does not include:

(a)

feed;

(b)	live animals unless they are prepared for placing on the market for human consumption;

(c)	plants prior to harvesting;

(d)	medicinal products within the meaning of point (2) of Article 1 of Directive 2001/83/EC of the European Parliament and of the Council (10);

(e)	cosmetic products within the meaning of point (a) of Article 2(1) of Regulation (EC) No 1223/2009 of the European Parliament and of the Council (11);

(f)	tobacco and tobacco products within the meaning of, respectively, points (1) and (4) of Article 2 of Directive 2014/40/EU of the European Parliament and of the Council (12);

(g)	narcotic or psychotropic substances within the meaning of the United Nations Single Convention on Narcotic Drugs, 1961, and the United Nations Convention on Psychotropic Substances, 1971;

(h)	residues and contaminants;

(i)	water intended for human consumption within the meaning of point (1) of Article 2 of Directive 2013/51/Euratom;

(2)	‘minor food’ means food of minor dietary importance which makes only a marginal contribution to food consumption by the population;

(3)	‘feed’ means any substance or product, including additives, whether processed, partially processed or unprocessed, intended to be used for oral feeding to animals;

(4)	‘placing on the market’ means the holding of food or feed for the purpose of sale, including offering for sale or any other form of transfer, whether free of charge or not, and the sale, distribution and other forms of transfer themselves;

(5)

‘radiological emergency’ means a non-routine situation or event involving a radiation source that necessitates prompt action to mitigate serious adverse consequences for human health and safety, quality of life, property or the environment, or a hazard that could give rise to such serious adverse consequences.

Article 3

Applicable maximum permitted levels

1. If the Commission receives — in particular either under the Community arrangements for the early exchange of information in the event of a radiological emergency, or under the IAEA Convention on Early Notification of a Nuclear Accident of 26 September 1986 — official information on a nuclear accident or on any other case of radiological emergency which is likely to lead to or has led to significant radioactive contamination of food and feed, it shall adopt an implementing Regulation rendering applicable maximum permitted levels to the potentially contaminated food or feed that could be placed on the market.

Without prejudice to Article 3(4), the applicable maximum permitted levels set out in such an implementing Regulation shall not exceed those set out in Annexes I, II and III. That implementing Regulation shall be adopted in accordance with the examination procedure referred to in Article 5(2).

On duly justified imperative grounds of urgency relating to the circumstances of the nuclear accident or other radiological emergency, the Commission shall adopt an immediately applicable implementing Regulation in accordance with the procedure referred to in Article 5(3).

2. The period of validity of implementing Regulations adopted under paragraph 1 shall be as short as possible. The duration of the first implementing Regulation following a nuclear accident or any other case of radiological emergency shall not exceed 3 months.

Implementing Regulations shall be periodically reviewed by the Commission and, if appropriate, amended on the basis of the nature and location of the accident and of the evolution of the level of radioactive contamination effectively measured.

3. When preparing or reviewing implementing Regulations, the Commission shall take into account the basic standards laid down pursuant to Articles 30 and 31 of the Treaty, including the justification principle and the optimisation principle, with the aim of keeping the magnitude of individual doses, the likelihood of exposure and the number of individuals exposed as low as reasonably achievable, taking into account the current state of technical knowledge and economic and societal factors.

When reviewing implementing Regulations, the Commission shall consult the group of experts referred to in Article 31 of the Treaty if a nuclear accident or any other case of radiological emergency causes such widespread contamination of food or feed consumed in the Community that the rationale and assumptions underpinning the maximum permitted levels set out in Annexes I, II and III to this Regulation are no longer valid. The Commission may seek the opinion of that group of experts in any other case of contamination of food or feed consumed in the Community.

4. Without prejudice to the health protection objective pursued by this Regulation, the Commission may, by means of implementing Regulations, allow any Member State, at its request and in the light of exceptional circumstances prevailing in that Member State, to derogate temporarily from the maximum permitted levels in respect of specified food or feed consumed on its territory. Those derogations shall be based on scientific evidence and be duly justified by the circumstances, in particular societal factors, prevailing in the Member State concerned.

Article 4

Restrictive measures

1. When the Commission adopts an implementing Regulation rendering applicable maximum permitted levels, food or feed not in compliance with those maximum permitted levels shall not be placed on the market, as from the date specified in that implementing Regulation.

For the purposes of applying this Regulation, food or feed imported from third countries shall be considered to be placed on the market if, on the customs territory of the Union, it is placed under a customs procedure other than a transit procedure.

2. Each Member State shall provide the Commission with all information concerning the application of this Regulation. The Commission shall communicate such information to the other Member States. Any case of non-compliance with the applicable maximum permitted levels shall be notified through the Rapid Alert System for Food and Feed (RAFF).

Article 5

Committee procedure

1. The Commission shall be assisted by the Standing Committee on Plants, Animals, Food and Feed established by Article 58(1) of Regulation (EC) No 178/2002. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

3. Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply.

Article 6

Reporting

In the event of a nuclear accident or any other case of a radiological emergency which is likely to lead to or has led to significant radioactive contamination of food and feed, the Commission shall submit to the European Parliament and to the Council a report. The report shall cover the implementation of the measures undertaken pursuant to this Regulation and notified to the Commission in accordance with Article 4(2).

Article 7

Repeal

Council Regulation (Euratom) No 3954/87 and Commission Regulations (Euratom) No 944/89 (13) and (Euratom) No 770/90 (14) are repealed.

References to the repealed Regulations shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex IV.

Article 8

Entry into force

This Regulation shall enter into force on the twentieth 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, 15 January 2016.

For the Council

The President

J.R.V.A. DIJSSELBLOEM

(1) Opinion of 9 July 2015 (not yet published in the Official Journal).

(2) OJ C 226, 16.7.2014, p. 68.

(3) Council Directive 2013/59/Euratom of 5 December 2013 laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation, and repealing Directives 89/618/Euratom, 90/641/Euratom, 96/29/Euratom, 97/43/Euratom and 2003/122/Euratom (OJ L 13, 17.1.2014, p. 1).

(4) Council Regulation (Euratom) No 3954/87 of 22 December 1987 laying down maximum permitted levels of radioactive contamination of foodstuffs and of feedingstuffs following a nuclear accident or any other case of radiological emergency (OJ L 371, 30.12.1987, p. 11).

(5) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).

(6) Council Directive 2013/51/Euratom of 22 October 2013 laying down requirements for the protection of the health of the general public with regard to radioactive substances in water intended for human consumption (OJ L 296, 7.11.2013, p. 12).

(7) Council Decision 87/600/Euratom of 14 December 1987 on Community arrangements for the early exchange of information in the event of radiological emergency (OJ L 371, 30.12.1987, p. 76).

(8) Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).

(9) Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (OJ L 165, 30.4.2004, p. 1).

(10) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).

(11) Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59).

(12) Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC (OJ L 127, 29.4.2014, p. 1).

(13) Commission Regulation (Euratom) No 944/89 of 12 April 1989 laying down maximum permitted levels of radioactive contamination in minor foodstuffs following a nuclear accident or any other case of radiological emergency (OJ L 101, 13.4.1989, p. 17).

(14) Commission Regulation (Euratom) No 770/90 of 29 March 1990 laying down maximum permitted levels of radioactive contamination of feedingstuffs following a nuclear accident or any other case of radiological emergency (OJ L 83, 30.3.1990, p. 78).

ANNEX I

MAXIMUM PERMITTED LEVELS OF RADIOACTIVE CONTAMINATION OF FOOD

The maximum permitted levels to be applied to food shall not exceed the following:

Isotope group/Food group	Food (Bq/kg) (1)
Isotope group/Food group	Infant food (2)	Dairy produce (3)	Other food except minor food (4)	Liquid food (5)
Sum of isotopes of strontium, notably Sr-90	75	125	750	125
Sum of isotopes of iodine, notably I-131	150	500	2 000	500
Sum of alpha-emitting isotopes of plutonium and transplutonium elements, notably Pu-239 and Am-241	1	20	80	20
Sum of all other nuclides of half-life greater than 10 days, notably Cs-134 and Cs-137 (6)	400	1 000	1 250	1 000

(1) The level applicable to concentrated or dried products is calculated on the basis of the reconstituted product as ready for consumption. Member States may make recommendations concerning the diluting conditions in order to ensure that the maximum permitted levels laid down in this Regulation are observed.

(2) Infant food is defined as food intended for the feeding of infants during the first 12 months of life which meets, in itself, the nutritional requirements of this category of persons and is put up for retail sale in packages which are clearly identified and labelled as such.

(3) Dairy produce is defined as products falling within the following CN codes including, where appropriate, any adjustments which might subsequently be made to them: 0401 and 0402 (except 0402 29 11).

(4) Minor food and the corresponding levels to be applied to them are set out in Annex II.

(5) Liquid food is defined as products falling within heading 2009 and Chapter 22 of the Combined Nomenclature. Values are calculated taking into account consumption of tap-water and the same values could be applied to drinking water supplies at the discretion of competent authorities in Member States.

(6) Carbon-14, tritium and potassium-40 are not included in this group.

ANNEX II

MAXIMUM PERMITTED LEVELS OF RADIOACTIVE CONTAMINATION OF MINOR FOOD

List of minor food

CN code	Description
0703 20 00	Garlic (fresh or chilled))
0709 59 50	Truffles (fresh or chilled)
0709 99 40	Capers (fresh or chilled)
0711 90 70	Capers (provisionally preserved, but unsuitable in that state for immediate consumption)
ex 0712 39 00	Truffles (dried, whole, cut, sliced, broken or in powder, but not further prepared)
0714	Manioc, arrowroot, salep, Jerusalem artichokes, sweet potatoes and similar roots and tubers with high starch or inulin content, fresh, chilled, frozen or dried, whether or not sliced or in the form of pellets; sago pith
0814 00 00	Peel of citrus fruit or melons (including watermelons), fresh, frozen, dried or provisionally preserved in brine, in sulphur water or in other preservative solutions
0903 00 00	Maté
0904	Pepper of the genus Piper; dried or crushed or ground fruit of the genus Capsicum or of the genus Pimenta
0905 00 00	Vanilla
0906	Cinnamon and cinnamon-tree flowers
0907 00 00	Cloves (whole fruit, cloves and stems)
0908	Nutmeg, mace and cardamoms
0909	Seeds of anise, badian, fennel, coriander, cumin or caraway; juniper berries
0910	Ginger, saffron, turmeric (curcuma), thyme, bay leaves, curry and other spices
1106 20	Flour, meal and powder of sago or of roots or tubers of heading 0714
1108 14 00	Manioc (cassava) starch
1210	Hop cones, fresh or dried, whether or not ground, powdered or in the form of pellets; lupulin
1211	Plants and parts of plants (including seeds and fruits), of a kind used primarily in perfumery, in pharmacy or for insecticidal, fungicidal or similar purposes, fresh or dried, whether or not cut, crushed or powdered, except plants or parts of plants used for food production
1301	Lac; natural gums, resins, gum-resins and oleoresins (for example, balsams)
1302	Vegetable saps and extracts; pectic substances, pectinates and pectates; agar-agar and other mucilages and thickeners, whether or not modified, derived from vegetable products
1504	Fats and oils and their fractions, of fish or marine mammals, whether or not refined, but not chemically modified
1604 31 00	Caviar
1604 32 00	Caviar substitutes
1801 00 00	Cocoa beans, whole or broken, raw or roasted
1802 00 00	Cocoa shells, husks, skins and other cocoa waste
1803	Cocoa paste, whether or not defatted
2003 90 10	Truffles (prepared or preserved otherwise than by vinegar or acetic acid)
2006 00	Vegetables, fruit, nuts, fruit-peel and other parts of plants, preserved by sugar (drained, glacé or crystallised)
2102	Yeasts (active or inactive); other single-cell micro-organisms, dead (but not including vaccines of heading 3002); prepared baking powders
2936	Provitamins and vitamins, natural or reproduced by synthesis (including natural concentrates), derivatives thereof used primarily as vitamins, and intermixtures of the foregoing, whether or not in any solvent
3301	Essential oils (terpeneless or not), including concretes and absolutes; resinoids; extracted oleoresins; concentrates of essential oils in fats, in fixed oils, in waxes or the like, obtained by enfleurage or maceration; terpenic by-products of the deterpenation of essential oils; aqueous distillates and aqueous solutions of essential oils

The maximum permitted levels to be applied to the minor food as listed in point 1 shall not exceed the following:

Isotope group	Bq/kg
Sum of isotopes of strontium, notably Sr-90	7 500
Sum of isotopes of iodine, notably I-131	20 000
Sum of alpha-emitting isotopes of plutonium and transplutonium elements, notably Pu-239 and Am-241	800
Sum of all other nuclides of half-life greater than 10 days, notably Cs-134 and Cs-137 (1)	12 500

(1) Carbon-14, tritium and potassium-40 are not included in this group.

ANNEX III

MAXIMUM PERMITTED LEVELS OF RADIOACTIVE CONTAMINATION OF FEED

The maximum permitted levels for the sum of caesium-134 and caesium-137 shall not exceed the following:

Feed for	Bq/kg (1) (2)
Pigs	1 250
Poultry, lambs, calves	2 500
Other	5 000

(1) These levels are intended to contribute to the observance of the maximum permitted levels for food; they do not alone guarantee such observance in all circumstances and do not lessen the requirement for monitoring contamination levels in animal products destined for human consumption.

(2) These levels apply to feed as ready for consumption.

ANNEX IV

CORRELATION TABLE

Regulation (Euratom) No 3954/87	Regulation (Euratom) No 944/89	Regulation (Euratom) No 770/90	This Regulation
Article 1(1)	Article 1	Article 1	Article 1
Article 1(2)			Article 2
Article 2(1)			Article 3(1)
Article 2(2)			Article 3(2)
Article 3(1)			—
Article 3(2)			Article 3(3)
Article 3(3) and (4)			—
Article 4			—
Article 5			—
Article 6(1)			Article 4(1)
Article 6(2)			Article 4(2)
	Article 2		Annex II, point 2
—	—	—	Article 5
Article 7			—
—	—	—	Article 7
Article 8	Article 3	Article 2	Article 8
Annex			Annex I
	Annex		Annex II, point 1
		Annex	Annex III
—	—	—	Annex IV

20.1.2016

Official Journal of the European Union

L 13/12

COMMISSION REGULATION (EU) 2016/53

of 19 January 2016

amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for diethofencarb, mesotrione, metosulam and pirimiphos-methyl in or on certain products

(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 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (1), and in particular Article 14(1)(a), Article 18(1)(b) and Article 49(2) thereof,

Whereas:

(1)	For diethofencarb and metosulam, maximum residue levels (MRLs) were set in Part A of Annex III to Regulation (EC) No 396/2005. For mesotrione and pirimiphos-methyl, MRLs were set in Annex II and Part B of Annex III to that Regulation.

(2)

For diethofencarb, the European Food Safety Authority, hereinafter ‘the Authority’, submitted a reasoned opinion on the existing MRLs in accordance with Article 12(1) of Regulation (EC) No 396/2005 (2). It concluded that concerning the MRLs for pears, wine grapes, tomatoes and aubergines some information was not available and that further consideration by risk managers was required. As there is no risk for consumers, the MRLs for those products should be set in Annex II to Regulation (EC) No 396/2005 at the existing level or the level identified by the Authority. These MRLs will be reviewed; the review will take into account the information available within two years from the publication of this Regulation. The Authority concluded that concerning the MRLs for cucumbers, courgettes, bovine muscle, fat, liver and kidney, sheep muscle, fat, liver and kidney, goat muscle, fat, liver and kidney, bovine, sheep and goat milk no information was available and that further consideration by risk managers was required. The MRLs for these products should be set at the specific limit of determination. As not data were available for setting MRLs in commodities of animal origin, also the MRL for apple, which is used as animal feed, should be set at the specific limit of determination.

(3)

For mesotrione, the Authority, submitted a reasoned opinion on the existing MRLs in accordance with Article 12(2) of Regulation (EC) No 396/2005 in conjunction with Article 12(1) thereof (3). It proposed to change the residue definition and recommended lowering the MRLs for sweet corn, linseed, poppy seed, rape seed and maize. It concluded that concerning the MRL for sugar cane some information was not available and that further consideration by risk managers was required. As there is no risk for consumers, the MRL for this product should be set in Annex II to Regulation (EC) No 396/2005 at the existing level or the level identified by the Authority. This MRL will be reviewed; the review will take into account the information available within two years from the publication of this Regulation. The Authority concluded that concerning the MRL for sea weeds no information was available, and that further consideration by risk managers was required. The MRL for this product should be set at the specific limit of determination.

(4)

For metosulam, the Authority, submitted a reasoned opinion on the existing MRLs in accordance with Article 12(1) of Regulation (EC) No 396/2005 (4). It recommended lowering the MRLs for barley, maize, oats, rye and wheat grain. It concluded that concerning the MRLs for pome fruit, stone fruit, table grapes, wine grapes, strawberries, cane fruit, other small fruit and berries, potatoes and sweet corn some information was not available and that further consideration by risk managers was required. As there is no risk for consumers, the MRLs for these products should be set in Annex II to Regulation (EC) No 396/2005 at the existing level or the level identified by the Authority. These MRLs will be reviewed; the review will take into account the information available within two years from the publication of this Regulation.

(5)

For pirimiphos-methyl, the Authority, submitted a reasoned opinion on the existing MRLs in accordance with Article 12(2) of Regulation (EC) No 396/2005 in conjunction with Article 12(1) thereof (5). It identified a long-term risk for consumers for all MRLs. It is therefore appropriate to lower the MRLs for buckwheat, maize, rice and rye. It concluded that concerning the MRLs for barley, millet, oats, sorghum, wheat, swine muscle, fat, liver and kidney, bovine muscle, fat, liver and kidney, sheep muscle, fat, liver and kidney, goat muscle, fat, liver and kidney, poultry muscle, fat and liver, bovine, sheep and goat milk and bird eggs some information was not available and that further consideration by risk managers was required. As there is no risk for consumers, the MRLs for these products should be set in Annex II to Regulation (EC) No 396/2005 at the existing level or the level identified by the Authority. These MRLs will be reviewed; the review will take into account the information available within two years from the publication of this Regulation. The Authority concluded that concerning the MRLs for almonds, hazelnuts, pistachios, walnuts, pulses (dry) and palm nuts no information was available, and that further consideration by risk managers was required. The MRLs for these products should be set at the specific limit of determination. The Authority concluded that concerning the MRLs for linseed, peanuts, poppy seed, sesame seed, sunflower seed, rape seed, soya bean, mustard seed, cotton seed, pumpkin seeds, safflower, borage, gold of pleasure, hempseed and castor bean no information was available, and that further consideration by risk managers was required. As there is a risk for cross-contamination, the MRLs for these products as well as for buckwheat, maize, rice and rye should be set at the level identified by the Authority.

(6)

As regards products on which the use of the plant protection product concerned is not authorised, and for which no import tolerances or Codex maximum residue limits (CXLs) exist, MRLs should be set at the specific limit of determination or the default MRL should apply, as provided for in Article 18(1)(b) of Regulation (EC) No 396/2005.

(7)

The Commission consulted the European Union reference laboratories for residues of pesticides as regards the need to adapt certain limits of determination. As regards several substances, those laboratories concluded that for certain commodities technical development requires the setting of specific limits of determination.

(8)	Based on the reasoned opinions of the Authority and taking into account the factors relevant to the matter under consideration, the appropriate modifications to the MRLs fulfil the requirements of Article 14(2) of Regulation (EC) No 396/2005.

(9)	Through the World Trade Organisation, the trading partners of the Union were consulted on the new MRLs and their comments have been taken into account.

(10)	Regulation (EC) No 396/2005 should therefore be amended accordingly.

(11)

In order to allow for the normal marketing, processing and consumption of products, this Regulation should provide for a transitional arrangement for products which have been produced before the modification of the MRLs and for which information shows that a high level of consumer protection is maintained.

(12)	A reasonable period should be allowed to elapse before the modified MRLs become applicable in order to permit Member States, third countries and food business operators to prepare themselves to meet the new requirements which will result from the modification of the MRLs.

(13)	The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Annexes II and III to Regulation (EC) No 396/2005 are amended in accordance with the Annex to this Regulation.

Article 2

Regulation (EC) No 396/2005 as it stood before being amended by this Regulation shall continue to apply to products which were produced before 9 August 2016.

Article 3

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from 9 August 2016.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 19 January 2016.

For the Commission

The President

Jean-Claude JUNCKER

(1) OJ L 70, 16.3.2005, p. 1.

(2) European Food Safety Authority; Review of the existing maximum residue levels (MRLs) for diethofencarb according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2015;13(2):4030.

(3) European Food Safety Authority; Review of the existing maximum residue levels (MRLs) for mesotrione according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2015;13(1):3976.

(4) European Food Safety Authority; Review of the existing maximum residue levels (MRLs) for metosulam according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2015;13(1):3983.

(5) European Food Safety Authority; Review of the existing maximum residue levels (MRLs) for pirimiphos-methyl according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2015;13(1):3974.

ANNEX

Annexes II and III to Regulation (EC) No 396/2005 are amended as follows:

(1)

Annex II is amended as follows:

(a)

the columns for mesotrione and pirimiphos-methyl are replaced by the following:

‘Pesticide residues and maximum residue levels (mg/kg)

Code number

Groups and examples of individual products to which the MRLs apply (2)

Mesotrione

Pirimiphos-methyl (F)

(1)

(2)

(3)

(4)

0100000

FRUITS, FRESH or FROZEN; TREE NUTS

0,01 (1)

0110000

Citrus fruits

0110010

Grapefruits

0110020

Oranges

0110030

Lemons

0110040

Limes

0110050

Mandarins

0110990

Others

0120000

Tree nuts

0120010

Almonds

0120020

Brazil nuts

0120030

Cashew nuts

0120040

Chestnuts

0120050

Coconuts

0120060

Hazelnuts/cobnuts

0120070

Macadamias

0120080

Pecans

0120090

Pine nut kernels

0120100

Pistachios

0120110

Walnuts

0120990

Others

0130000

Pome fruits

0130010

Apples

0130020

Pears

0130030

Quinces

0130040

Medlars

0130050

Loquats/Japanese medlars

0130990

Others

0140000

Stone fruits

0140010

Apricots

0140020

Cherries (sweet)

0140030

Peaches

0140040

Plums

0140990

Others

0150000

Berries and small fruits

0151000

(a)

grapes

0151010

Table grapes

0151020

Wine grapes

0152000

(b)	strawberries

0153000

(c)	cane fruits

0153010

Blackberries

0153020

Dewberries

0153030

Raspberries (red and yellow)

0153990

Others

0154000

(d)	other small fruits and berries

0154010

Blueberries

0154020

Cranberries

0154030

Currants (black, red and white)

0154040

Gooseberries (green, red and yellow)

0154050

Rose hips

0154060

Mulberries (black and white)

0154070

Azaroles/Mediterranean medlars

0154080

Elderberries

0154990

Others

0160000

Miscellaneous fruits with

0161000

(a)	edible peel

0161010

Dates

0161020

Figs

0161030

Table olives

0161040

Kumquats

0161050

Carambolas

0161060

Kaki/Japanese persimmons

0161070

Jambuls/jambolans

0161990

Others

0162000

(b)	inedible peel, small

0162010

Kiwi fruits (green, red, yellow)

0162020

Litchis/lychees

0162030

Passionfruits/maracujas

0162040

Prickly pears/cactus fruits

0162050

Star apples/cainitos

0162060

American persimmons/Virginia kaki

0162990

Others

0163000

(c)	inedible peel, large

0163010

Avocados

0163020

Bananas

0163030

Mangoes

0163040

Papayas

0163050

Granate apples/pomegranates

0163060

Cherimoyas

0163070

Guavas

0163080

Pineapples

0163090

Breadfruits

0163100

Durians

0163110

Soursops/guanabanas

0163990

Others

0200000

VEGETABLES, FRESH or FROZEN

0210000

Root and tuber vegetables

0,01 (1)

0211000

(a)

potatoes

0212000

(b)	tropical root and tuber vegetables

0212010

Cassava roots/manioc

0212020

Sweet potatoes

0212030

Yams

0212040

Arrowroots

0212990

Others

0213000

(c)	other root and tuber vegetables except sugar beets

0213010

Beetroots

0213020

Carrots

0213030

Celeriacs/turnip rooted celeries

0213040

Horseradishes

0213050

Jerusalem artichokes

0213060

Parsnips

0213070

Parsley roots/Hamburg roots parsley

0213080

Radishes

0213090

Salsifies

0213100

Swedes/rutabagas

0213110

Turnips

0213990

Others

0220000

Bulb vegetables

0,01 (1)

0220010

Garlic

0220020

Onions

0220030

Shallots

0220040

Spring onions/green onions and Welsh onions

0220990

Others

0230000

Fruiting vegetables

0,01 (1)

0231000

(a)

solanacea

0231010

Tomatoes

0231020

Sweet peppers/bell peppers

0231030

Aubergines/eggplants

0231040

Okra/lady's fingers

0231990

Others

0232000

(b)	cucurbits with edible peel

0232010

Cucumbers

0232020

Gherkins

0232030

Courgettes

0232990

Others

0233000

(c)	cucurbits with inedible peel

0233010

Melons

0233020

Pumpkins

0233030

Watermelons

0233990

Others

0234000

(d)	sweet corn

0239000

(e)	other fruiting vegetables

0240000

Brassica vegetables (excluding brassica roots and brassica baby leaf crops)

0,01 (1)

0241000

(a)	flowering brassica

0241010

Broccoli

0241020

Cauliflowers

0241990

Others

0242000

(b)	head brassica

0242010

Brussels sprouts

0242020

Head cabbages

0242990

Others

0243000

(c)	leafy brassica

0243010

Chinese cabbages/pe-tsai

0243020

Kales

0243990

Others

0244000

(d)	kohlrabies

0250000

Leaf vegetables, herbs and edible flowers

0251000

(a)	lettuces and salad plants

0,01 (1)

0251010

Lamb's lettuces/corn salads

0251020

Lettuces

0251030

Escaroles/broad-leaved endives

0251040

Cresses and other sprouts and shoots

0251050

Land cresses

0251060

Roman rocket/rucola

0251070

Red mustards

0251080

Baby leaf crops (including brassica species)

0251990

Others

0252000

(b)	spinaches and similar leaves

0,01 (1)

0252010

Spinaches

0252020

Purslanes

0252030

Chards/beet leaves

0252990

Others

0253000

(c)	grape leaves and similar species

0,01 (1)

0254000

(d)	watercresses

0,01 (1)

0255000

(e)	witloofs/Belgian endives

0,01 (1)

0256000

(f)	herbs and edible flowers

0,02 (1)

0256010

Chervil

0256020

Chives

0256030

Celery leaves

0256040

Parsley

0256050

Sage

0256060

Rosemary

0256070

Thyme

0256080

Basil and edible flowers

0256090

Laurel/bay leave

0256100

Tarragon

0256990

Others

0260000

Legume vegetables

0,01 (1)

0260010

Beans (with pods)

0260020

Beans (without pods)

0260030

Peas (with pods)

0260040

Peas (without pods)

0260050

Lentils

0260990

Others

0270000

Stem vegetables

0,01 (1)

0270010

Asparagus

0270020

Cardoons

0270030

Celeries

0270040

Florence fennels

0270050

Globe artichokes

0270060

Leeks

0270070

Rhubarbs

0270080

Bamboo shoots

0270090

Palm hearts

0270990

Others

0280000

Fungi, mosses and lichens

0,01 (1)

0280010

Cultivated fungi

0280020

Wild fungi

0280990

Mosses and lichens

0290000

Algae and prokaryotes organisms

0,01 (1)

0300000

PULSES

0,01 (1)

0300010

Beans

0300020

Lentils

0300030

Peas

0300040

Lupins/lupini beans

0300990

Others

0400000

OILSEEDS AND OIL FRUITS

0,01 (1)

0401000

Oilseeds

0,5

0401010

Linseeds

0401020

Peanuts/groundnuts

0401030

Poppy seeds

0401040

Sesame seeds

0401050

Sunflower seeds

0401060

Rapeseeds/canola seeds

0401070

Soyabeans

0401080

Mustard seeds

0401090

Cotton seeds

0401100

Pumpkin seeds

0401110

Safflower seeds

0401120

Borage seeds

0401130

Gold of pleasure seeds

0401140

Hemp seeds

0401150

Castor beans

0401990

Others

0402000

Oil fruits

0,01 (1)

0402010

Olives for oil production

0402020

Oil palms kernels

0402030

Oil palms fruits

0402040

Kapok

0402990

Others

0500000

CEREALS

0,01 (1)

0500010

Barley

5 (+)

0500020

Buckwheat and other pseudo-cereals

0,5

0500030

Maize/corn

0,5

0500040

Common millet/proso millet

5 (+)

0500050

Oat

5 (+)

0500060

Rice

0,5

0500070

Rye

0,5

0500080

Sorghum

5 (+)

0500090

Wheat

5 (+)

0500990

Others

0,5

0600000

TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS

0,05 (1)

0610000

Teas

0620000

Coffee beans

0630000

Herbal infusions from

0631000

(a)

flowers

0631010

Chamomile

0631020

Hibiscus/roselle

0631030

Rose

0631040

Jasmine

0631050

Lime/linden

0631990

Others

0632000

(b)	leaves and herbs

0632010

Strawberry

0632020

Rooibos

0632030

Mate/maté

0632990

Others

0633000

(c)

roots

0633010

Valerian

0633020

Ginseng

0633990

Others

0639000

(d)	any other parts of the plant

0640000

Cocoa beans

0650000

Carobs/Saint John's breads

0700000

HOPS

0,05 (1)

0800000

SPICES

0810000

Seed spices

0,05 (1)

0810010

Anise/aniseed

0810020

Black caraway/black cumin

0810030

Celery

0810040

Coriander

0810050

Cumin

0810060

Dill

0810070

Fennel

0810080

Fenugreek

0810090

Nutmeg

0810990

Others

0820000

Fruit spices

0,05 (1)

0,5

0820010

Allspice/pimento

0820020

Sichuan pepper

0820030

Caraway

0820040

Cardamom

0820050

Juniper berry

0820060

Peppercorn (black, green and white)

0820070

Vanilla

0820080

Tamarind

0820990

Others

0830000

Bark spices

0,05 (1)

0830010

Cinnamon

0830990

Others

0840000

Root and rhizome spices

0840010

Liquorice

0,05 (1)

0840020

Ginger

0,05 (1)

0840030

Turmeric/curcuma

0,05 (1)

0840040

Horseradish

(+)

0840990

Others

0,05 (1)

0850000

Bud spices

0,05 (1)

0850010

Cloves

0850020

Capers

0850990

Others

0860000

Flower pistil spices

0,05 (1)

0860010

Saffron

0860990

Others

0870000

Aril spices

0,05 (1)

0870010

Mace

0870990

Others

0900000

SUGAR PLANTS

0,01 (1)

0900010

Sugar beet roots

0900020

Sugar canes

(+)

0900030

Chicory roots

0900990

Others

1000000

PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS

1010000

Tissues from

0,01 (1)

1011000

(a)

swine

1011010

Muscle

(+)

1011020

Fat tissue

(+)

1011030

Liver

(+)

1011040

Kidney

(+)

1011050

Edible offals (other than liver and kidney)

1011990

Others

1012000

(b)

bovine

1012010

Muscle

(+)

1012020

Fat tissue

(+)

1012030

Liver

(+)

1012040

Kidney

(+)

1012050

Edible offals (other than liver and kidney)

1012990

Others

1013000

(c)

sheep

1013010

Muscle

(+)

1013020

Fat tissue

(+)

1013030

Liver

(+)

1013040

Kidney

(+)

1013050

Edible offals (other than liver and kidney)

1013990

Others

1014000

goat

1014010

Muscle

(+)

1014020

Fat tissue

(+)

1014030

Liver

(+)

1014040

Kidney

(+)

1014050

Edible offals (other than liver and kidney)

1014990

Others

1015000

(e)

equine

1015010

Muscle

1015020

Fat tissue

1015030

Liver

1015040

Kidney

1015050

Edible offals (other than liver and kidney)

1015990

Others

1016000

(f)

poultry

1016010

Muscle

(+)

1016020

Fat tissue

(+)

1016030

Liver

(+)

1016040

Kidney

1016050

Edible offals (other than liver and kidney)

1016990

Others

1017000

(g)	other farmed terrestrial animals

1017010

Muscle

1017020

Fat tissue

1017030

Liver

1017040

Kidney

1017050

Edible offals (other than liver and kidney)

1017990

Others

1020000

Milk

0,01 (1)

1020010

Cattle

(+)

1020020

Sheep

(+)

1020030

Goat

(+)

1020040

Horse

1020990

Others

1030000

Birds eggs

0,01 (1)

0,01 (1) (+)

1030010

Chicken

1030020

Duck

1030030

Geese

1030040

Quail

1030990

Others

1040000

Honey and other apiculture products

0,05 (1)

1050000

Amphibians and Reptiles

0,01 (1)

1060000

Terrestrial invertebrate animals

0,01 (1)

1070000

Wild terrestrial vertebrate animals

0,01 (1)

(b)

the following columns for diethofencarb and metosulam are added:

‘Pesticide residues and maximum residue levels (mg/kg)

Code number

Groups and examples of individual products to which the MRLs apply (4)

Diethofencarb

Metosulam

(1)

(2)

(3)

(4)

0100000

FRUITS, FRESH or FROZEN; TREE NUTS

0,01 (3)

0110000

Citrus fruits

0,01 (3)

0110010

Grapefruits

0110020

Oranges

0110030

Lemons

0110040

Limes

0110050

Mandarins

0110990

Others

0120000

Tree nuts

0,01 (3)

0120010

Almonds

0120020

Brazil nuts

0120030

Cashew nuts

0120040

Chestnuts

0120050

Coconuts

0120060

Hazelnuts/cobnuts

0120070

Macadamias

0120080

Pecans

0120090

Pine nut kernels

0120100

Pistachios

0120110

Walnuts

0120990

Others

0130000

Pome fruits

(+)

0130010

Apples

0,01 (3)

0130020

Pears

0,8 (+)

0130030

Quinces

0,01 (3)

0130040

Medlars

0,01 (3)

0130050

Loquats/Japanese medlars

0,01 (3)

0130990

Others

0,01 (3)

0140000

Stone fruits

0,01 (3)

(+)

0140010

Apricots

0140020

Cherries (sweet)

0140030

Peaches

0140040

Plums

0140990

Others

0150000

Berries and small fruits

0151000

(a)

grapes

(+)

0151010

Table grapes

0,01 (3)

0151020

Wine grapes

0,9 (+)

0152000

(b)	strawberries

0,01 (3)

(+)

0153000

(c)	cane fruits

0,01 (3)

(+)

0153010

Blackberries

0153020

Dewberries

0153030

Raspberries (red and yellow)

0153990

Others

0154000

(d)	other small fruits and berries

0,01 (3)

(+)

0154010

Blueberries

0154020

Cranberries

0154030

Currants (black, red and white)

0154040

Gooseberries (green, red and yellow)

0154050

Rose hips

0154060

Mulberries (black and white)

0154070

Azaroles/Mediterranean medlars

0154080

Elderberries

0154990

Others

0160000

Miscellaneous fruits with

0,01 (3)

0161000

(a)	edible peel

0161010

Dates

0161020

Figs

0161030

Table olives

0161040

Kumquats

0161050

Carambolas

0161060

Kaki/Japanese persimmons

0161070

Jambuls/jambolans

0161990

Others

0162000

(b)	inedible peel, small

0162010

Kiwi fruits (green, red, yellow)

0162020

Litchis/lychees

0162030

Passionfruits/maracujas

0162040

Prickly pears/cactus fruits

0162050

Star apples/cainitos

0162060

American persimmons/Virginia kaki

0162990

Others

0163000

(c)	inedible peel, large

0163010

Avocados

0163020

Bananas

0163030

Mangoes

0163040

Papayas

0163050

Granate apples/pomegranates

0163060

Cherimoyas

0163070

Guavas

0163080

Pineapples

0163090

Breadfruits

0163100

Durians

0163110

Soursops/guanabanas

0163990

Others

0200000

VEGETABLES, FRESH or FROZEN

0210000

Root and tuber vegetables

0,01 (3)

0211000

(a)

potatoes

(+)

0212000

(b)	tropical root and tuber vegetables

0212010

Cassava roots/manioc

0212020

Sweet potatoes

0212030

Yams

0212040

Arrowroots

0212990

Others

0213000

(c)	other root and tuber vegetables except sugar beets

0213010

Beetroots

0213020

Carrots

0213030

Celeriacs/turnip rooted celeries

0213040

Horseradishes

0213050

Jerusalem artichokes

0213060

Parsnips

0213070

Parsley roots/Hamburg roots parsley

0213080

Radishes

0213090

Salsifies

0213100

Swedes/rutabagas

0213110

Turnips

0213990

Others

0220000

Bulb vegetables

0,01 (3)

0220010

Garlic

0220020

Onions

0220030

Shallots

0220040

Spring onions/green onions and Welsh onions

0220990

Others

0230000

Fruiting vegetables

0,01 (3)

0231000

(a)

solanacea

0231010

Tomatoes

0,7 (+)

0231020

Sweet peppers/bell peppers

0,01 (3)

0231030

Aubergines/eggplants

0,7 (+)

0231040

Okra/lady's fingers

0,01 (3)

0231990

Others

0,01 (3)

0232000

(b)	cucurbits with edible peel

0,01 (3)

0232010

Cucumbers

0232020

Gherkins

0232030

Courgettes

0232990

Others

0233000

(c)	cucurbits with inedible peel

0,01 (3)

0233010

Melons

0233020

Pumpkins

0233030

Watermelons

0233990

Others

0234000

(d)	sweet corn

0,01 (3)

(+)

0239000

(e)	other fruiting vegetables

0,01 (3)

0240000

Brassica vegetables (excluding brassica roots and brassica baby leaf crops)

0,01 (3)

0241000

(a)	flowering brassica

0241010

Broccoli

0241020

Cauliflowers

0241990

Others

0242000

(b)	head brassica

0242010

Brussels sprouts

0242020

Head cabbages

0242990

Others

0243000

(c)	leafy brassica

0243010

Chinese cabbages/pe-tsai

0243020

Kales

0243990

Others

0244000

(d)	kohlrabies

0250000

Leaf vegetables, herbs and edible flowers

0251000

(a)	lettuces and salad plants

0,01 (3)

0251010

Lamb's lettuces/corn salads

0251020

Lettuces

0251030

Escaroles/broad-leaved endives

0251040

Cresses and other sprouts and shoots

0251050

Land cresses

0251060

Roman rocket/rucola

0251070

Red mustards

0251080

Baby leaf crops (including brassica species)

0251990

Others

0252000

(b)	spinaches and similar leaves

0,01 (3)

0252010

Spinaches

0252020

Purslanes

0252030

Chards/beet leaves

0252990

Others

0253000

(c)	grape leaves and similar species

0,01 (3)

0254000

(d)	watercresses

0,01 (3)

0255000

(e)	witloofs/Belgian endives

0,01 (3)

0256000

(f)	herbs and edible flowers

0,02 (3)

0256010

Chervil

0256020

Chives

0256030

Celery leaves

0256040

Parsley

0256050

Sage

0256060

Rosemary

0256070

Thyme

0256080

Basil and edible flowers

0256090

Laurel/bay leave

0256100

Tarragon

0256990

Others

0260000

Legume vegetables

0,01 (3)

0260010

Beans (with pods)

0260020

Beans (without pods)

0260030

Peas (with pods)

0260040

Peas (without pods)

0260050

Lentils

0260990

Others

0270000

Stem vegetables

0,01 (3)

0270010

Asparagus

0270020

Cardoons

0270030

Celeries

0270040

Florence fennels

0270050

Globe artichokes

0270060

Leeks

0270070

Rhubarbs

0270080

Bamboo shoots

0270090

Palm hearts

0270990

Others

0280000

Fungi, mosses and lichens

0,01 (3)

0280010

Cultivated fungi

0280020

Wild fungi

0280990

Mosses and lichens

0290000

Algae and prokaryotes organisms

0,01 (3)

0300000

PULSES

0,01 (3)

0300010

Beans

0300020

Lentils

0300030

Peas

0300040

Lupins/lupini beans

0300990

Others

0400000

OILSEEDS AND OIL FRUITS

0,01 (3)

0401000

Oilseeds

0401010

Linseeds

0401020

Peanuts/groundnuts

0401030

Poppy seeds

0401040

Sesame seeds

0401050

Sunflower seeds

0401060

Rapeseeds/canola seeds

0401070

Soyabeans

0401080

Mustard seeds

0401090

Cotton seeds

0401100

Pumpkin seeds

0401110

Safflower seeds

0401120

Borage seeds

0401130

Gold of pleasure seeds

0401140

Hemp seeds

0401150

Castor beans

0401990

Others

0402000

Oil fruits

0402010

Olives for oil production

0402020

Oil palms kernels

0402030

Oil palms fruits

0402040

Kapok

0402990

Others

0500000

CEREALS

0,01 (3)

0500010

Barley

0500020

Buckwheat and other pseudo-cereals

0500030

Maize/corn

0500040

Common millet/proso millet

0500050

Oat

0500060

Rice

0500070

Rye

0500080

Sorghum

0500090

Wheat

0500990

Others

0600000

TEAS, COFFEE, HERBAL INFUSIONS, COCOA AND CAROBS

0,05 (3)

0610000

Teas

0620000

Coffee beans

0630000

Herbal infusions from

0631000

(a)

flowers

0631010

Chamomile

0631020

Hibiscus/roselle

0631030

Rose

0631040

Jasmine

0631050

Lime/linden

0631990

Others

0632000

(b)	leaves and herbs

0632010

Strawberry

0632020

Rooibos

0632030

Mate/maté

0632990

Others

0633000

(c)

roots

0633010

Valerian

0633020

Ginseng

0633990

Others

0639000

(d)	any other parts of the plant

0640000

Cocoa beans

0650000

Carobs/Saint John's breads

0700000

HOPS

0,05 (3)

0800000

SPICES

0810000

Seed spices

0,05 (3)

0810010

Anise/aniseed

0810020

Black caraway/black cumin

0810030

Celery

0810040

Coriander

0810050

Cumin

0810060

Dill

0810070

Fennel

0810080

Fenugreek

0810090

Nutmeg

0810990

Others

0820000

Fruit spices

0,05 (3)

0820010

Allspice/pimento

0820020

Sichuan pepper

0820030

Caraway

0820040

Cardamom

0820050

Juniper berry

0820060

Peppercorn (black, green and white)

0820070

Vanilla

0820080

Tamarind

0820990

Others

0830000

Bark spices

0,05 (3)

0830010

Cinnamon

0830990

Others

0840000

Root and rhizome spices

0840010

Liquorice

0,05 (3)

0840020

Ginger

0,05 (3)

0840030

Turmeric/curcuma

0,05 (3)

0840040

Horseradish

(+)

0840990

Others

0,05 (3)

0850000

Bud spices

0,05 (3)

0850010

Cloves

0850020

Capers

0850990

Others

0860000

Flower pistil spices

0,05 (3)

0860010

Saffron

0860990

Others

0870000

Aril spices

0,05 (3)

0870010

Mace

0870990

Others

0900000

SUGAR PLANTS

0,01 (3)

0900010

Sugar beet roots

0900020

Sugar canes

0900030

Chicory roots

0900990

Others

1000000

PRODUCTS OF ANIMAL ORIGIN -TERRESTRIAL ANIMALS

1010000

Tissues from

0,01 (3)

1011000

(a)

swine

1011010

Muscle

1011020

Fat tissue

1011030

Liver

1011040

Kidney

1011050

Edible offals (other than liver and kidney)

1011990

Others

1012000

(b)

bovine

1012010

Muscle

1012020

Fat tissue

1012030

Liver

1012040

Kidney

1012050

Edible offals (other than liver and kidney)

1012990

Others

1013000

(c)

sheep

1013010

Muscle

1013020

Fat tissue

1013030

Liver

1013040

Kidney

1013050

Edible offals (other than liver and kidney)

1013990

Others

1014000

goat

1014010

Muscle

1014020

Fat tissue

1014030

Liver

1014040

Kidney

1014050

Edible offals (other than liver and kidney)

1014990

Others

1015000

(e)

equine

1015010

Muscle

1015020

Fat tissue

1015030

Liver

1015040

Kidney

1015050

Edible offals (other than liver and kidney)

1015990

Others

1016000

(f)

poultry

1016010

Muscle

1016020

Fat tissue

1016030

Liver

1016040

Kidney

1016050

Edible offals (other than liver and kidney)

1016990

Others

1017000

(g)	other farmed terrestrial animals

1017010

Muscle

1017020

Fat tissue

1017030

Liver

1017040

Kidney

1017050

Edible offals (other than liver and kidney)

1017990

Others

1020000

Milk

0,01 (3)

1020010

Cattle

1020020

Sheep

1020030

Goat

1020040

Horse

1020990

Others

1030000

Birds eggs

0,01 (3)

1030010

Chicken

1030020

Duck

1030030

Geese

1030040

Quail

1030990

Others

1040000

Honey and other apiculture products

0,05 (3)

1050000

Amphibians and Reptiles

0,01 (3)

1060000

Terrestrial invertebrate animals

0,01 (3)

1070000

Wild terrestrial vertebrate animals

0,01 (3)

(2)

Annex III is amended as follows:

(a)	in Part A the columns for diethofencarb and metosulam are deleted;

(b)	in Part B the columns for mesotrione and pirimiphos-methyl are deleted.

(1) Indicates lower limit of analytical determination

(**)	Pesticide-code combination for which the MRL as set in Annex III Part B applies.

(F)= Fat soluble

Mesotrione

(+)

The applicable maximum residue level for horseradish (Armoracia rusticana) in the spice group (code 0840040) is the one set for horseradish (Armoracia rusticana) in the Vegetables category, root and tuber vegetables group (code 0213040) taking into account changes in the levels by processing (drying) according to Art. 20 (1) of Regulation (EC) No 396/2005.

0840040

Horseradish

(+)

The European Food Safety Authority identified some information on residue trials investgating residue levels of mesotrione and its metabolite AMBA (free and conjugated) as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 20 January 2018, or, if that information is not submitted by that date, the lack of it.

0900020

Sugar canes

Pirimiphos-methyl (F)

(+)

The European Food Safety Authority identified some information on analytical methods, toxicological data on the hydroxypyrimidine metabolites and hydrolysis studies simulating pasteurisation and sterilisation as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 20 January 2018, or, if that information is not submitted by that date, the lack of it.

0500010	Barley
0500040	Common millet/proso millet
0500050	Oat
0500080	Sorghum
0500090	Wheat

(+)

0840040

Horseradish

(+)

The European Food Safety Authority identified some information on toxicological data on the hydroxypyrimidine metabolites as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 20 January 2018, or, if that information is not submitted by that date, the lack of it.

1011010

Muscle

1011020

Fat tissue

1011030

Liver

1011040

Kidney

1012010

Muscle

1012020

Fat tissue

1012030

Liver

1012040

Kidney

1013010

Muscle

1013020

Fat tissue

1013030

Liver

1013040

Kidney

1014010

Muscle

1014020

Fat tissue

1014030

Liver

1014040

Kidney

1016010

Muscle

1016020

Fat tissue

1016030

Liver

1020010

Cattle

1020020

Sheep

1020030

Goat

1030000

Birds eggs

1030010

Chicken

1030020

Duck

1030030

Geese

1030040

Quail

1030990

Others’

(2) For the complete list of products of plant and animal origin to which MRLs apply, reference should be made to Annex I.

(F)= Fat soluble

Mesotrione

(+)

0840040

Horseradish

(+)

0900020

Sugar canes

Pirimiphos-methyl (F)

(+)

0500010	Barley
0500040	Common millet/proso millet
0500050	Oat
0500080	Sorghum
0500090	Wheat

(+)

0840040

Horseradish

(+)

1011010

Muscle

1011020

Fat tissue

1011030

Liver

1011040

Kidney

1012010

Muscle

1012020

Fat tissue

1012030

Liver

1012040

Kidney

1013010

Muscle

1013020

Fat tissue

1013030

Liver

1013040

Kidney

1014010

Muscle

1014020

Fat tissue

1014030

Liver

1014040

Kidney

1016010

Muscle

1016020

Fat tissue

1016030

Liver

1020010

Cattle

1020020

Sheep

1020030

Goat

1030000

Birds eggs

1030010

Chicken

1030020

Duck

1030030

Geese

1030040

Quail

1030990

Others’

(3) Indicates lower limit of analytical determination

(4) For the complete list of products of plant and animal origin to which MRLs apply, reference should be made to Annex I.

Diethofencarb

(+)

The European Food Safety Authority identified some information on residue trials and storage stability as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 20 January 2018, or, if that information is not submitted by that date, the lack of it.

0130020	Pears
0151020	Wine grapes

(+)

The European Food Safety Authority identified some information on storage stability as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 20 January 2018, or, if that information is not submitted by that date, the lack of it.

0231010	Tomatoes
0231030	Aubergines/eggplants

(+)

0840040

Horseradish

Metosulam

(+)

The European Food Safety Authority identified some information on storage stability, residue trials, crop metabolism and GAP parameters as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 20 January 2018, or, if that information is not submitted by that date, the lack of it.

0130000

Pome fruits

0130010

Apples

0130020

Pears

0130030

Quinces

0130040

Medlars

0130050

Loquats/Japanese medlars

0130990

Others

0140000

Stone fruits

0140010

Apricots

0140020

Cherries (sweet)

0140030

Peaches

0140040

Plums

0140990

Others

0151000

(a)

grapes

0151010

Table grapes

0151020

Wine grapes

0152000

(b)	strawberries

0153000

(c)	cane fruits

0153010

Blackberries

0153020

Dewberries

0153030

Raspberries (red and yellow)

0153990

Others

0154000

(d)	other small fruits and berries

0154010

Blueberries

0154020

Cranberries

0154030

Currants (black, red and white)

0154040

Gooseberries (green, red and yellow)

0154050

Rose hips

0154060

Mulberries (black and white)

0154070

Azaroles/Mediterranean medlars

0154080

Elderberries

0154990

Others

(+)

The European Food Safety Authority identified some information on storage stability and storage conditions used in the residue trials as unavailable. When re-viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 20 January 2018, or, if that information is not submitted by that date, the lack of it.

0211000

(a)

potatoes

(+)

0234000

(d)	sweet corn

(+)

0840040

Horseradish’

20.1.2016

Official Journal of the European Union

L 13/40

COMMISSION REGULATION (EU) 2016/54

of 19 January 2016

amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards inclusion of gamma-glutamyl-valyl-glycine in the Union list of flavouring 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 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC (1), and in particular Article 11(3),

Having regard to Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (2), and in particular Article 7(5) thereof,

Whereas:

(1)	Annex I to Regulation (EC) No 1334/2008 lays down a Union list of flavourings and source materials approved for use in and on foods and their conditions of use.

(2)	Commission Implementing Regulation (EU) No 872/2012 (3) adopted the list of flavouring substances and introduced that list in Part A of Annex I to Regulation (EC) No 1334/2008.

(3)	That list may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008, either on the initiative of the Commission or following an application submitted by a Member State or by an interested party.

(4)

On 21 March 2013, an application was submitted to the Commission for authorisation of the use of gamma-glutamyl-valyl-glycine [FL-no: 17.038] as a flavouring substance. The application was notified to the European Food Safety Authority (the Authority) for its opinion. The application was also made available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008.

(5)	The Authority evaluated the safety of gamma-glutamyl-valyl-glycine [FL-no: 17.038] when used as a flavouring substance (4) and concluded that its use does not give rise to safety concerns at its estimated level of intake as a flavouring substance.

(6)

The Union list referred to in Regulation (EC) No 1334/2008 is intended to regulate only the use of flavouring substances which are added to food in order to impart or modify odour and/or taste. Substance [FL-no: 17.038] could also be added to food for other purposes than flavouring and such uses remain subject to other rules. This Regulation lays down conditions of use which relate solely to the use of [FL-no: 17.038] as a flavouring substance.

(7)	Part A of Annex I to Regulation (EC) No 1334/2008 should therefore be amended accordingly.

(8)	The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Part A of Annex I to Regulation (EC) No 1334/2008 is amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the twentieth 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, 19 January 2016.

For the Commission

The President

Jean-Claude JUNCKER

(1) OJ L 354, 31.12.2008, p. 34.

(2) OJ L 354, 31.12.2008, p. 1.

(3) Commission Implementing Regulation (EU) No 872/2012 of 1 October 2012 adopting the list of flavouring substances provided for by Regulation (EC) No 2232/96 of the European Parliament and of the Council, introducing it in Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council and repealing Commission Regulation (EC) No 1565/2000 and Commission Decision 1999/217/EC (OJ L 267, 2.10.2012, p. 1).

(4) EFSA Journal 2014;12(4):3625.

ANNEX

In Part A, Section 2 of Annex I to Regulation (EC) No 1334/2008 the following entry concerning [FL-no: 17.038] is added at the end of the table:

‘17.038

gamma-glutamyl-valyl-glycine

338837-70-6

2123

5-oxo-L-prolyl-L-valyl-glycine (PCA-Val-Gly) and L-alpha-glutamyl-L-valyl-glycine less than 0,7 %, L-gamma-glutamyl-L-valyl-L-valyl-glycine less than 2,0 %, Toluene not detectable (l.o.d. 10 mg/kg)

Restrictions for use as a flavouring substance:

In category 1 — not more than 50 mg/kg

In categories 2 and 5 — not more than 60 mg/kg

In category 6.3, breakfast cereals, — not more than 160 mg/kg

In category 7.2 — not more than 60 mg/kg

In category 8 — not more than 45 mg/kg

In category 12 — not more than 160 mg/kg

In category 14.1 — not more than 15 mg/kg

In category 15 — not more than 160 mg/kg

EFSA’

20.1.2016

Official Journal of the European Union

L 13/43

COMMISSION REGULATION (EU) 2016/55

of 19 January 2016

amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards certain flavouring substances

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Whereas:

(1)	Annex I to Regulation (EC) No 1334/2008 lays down a Union list of flavourings and source materials for use in food and their conditions of use.

(2)	Commission Implementing Regulation (EU) No 872/2012 (3) adopted the list of flavouring substances and introduced that list in Part A of Annex I to Regulation (EC) No 1334/2008.

(3)	That list may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008, either on the initiative of the Commission or following an application submitted by a Member State or by an interested party.

(4)	Part A of the Union list contains both evaluated flavouring substances, which are assigned no footnotes, and flavouring substances under evaluation, which are identified by footnote references 1 to 4 in that list.

(5)

The European Food Safety Authority (EFSA) has completed the assessment of 5 substances which are currently listed as flavouring substances under evaluation. Those flavouring substances were assessed by EFSA in the following flavouring group evaluations: evaluation FGE.12rev5 (4) (substances FL-nos. 07.041 and 07.224), FGE.63rev2 (5) (substances FL-nos. 07.099 and 07.101), and evaluation FGE.312 (6) (substance FL-no 16.126). EFSA concluded that these flavouring substances do not give rise to safety concerns at the estimated levels of dietary intake.

(6)	As part of its evaluation, EFSA has made comments on the specifications of certain of those substances. The comments are related to names, purity or composition of the substances FL-nos: 07.041, 07.224 and 07.099. Those comments should be introduced in the list.

(7)

The Union list referred to in Regulation (EC) No 1334/2008 is intended to regulate only the use of flavouring substances which are added to food in order to impart or modify odour and/or taste. Substance FL-no 16.126 could also be added to food for other purposes than flavouring and such uses remain subject to other rules. This Regulation lays down conditions of use which relate solely to its use as a flavouring substance.

(8)	The flavouring substances assessed in those evaluations should be listed as evaluated substances by deleting footnote references 1 and 2 in the relevant entries of the Union list.

(9)	Part A of Annex I to Regulation (EC) No 1334/2008 should therefore be amended accordingly.

(10)	The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Part A of Annex I to Regulation (EC) No 1334/2008 is amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the twentieth 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, 19 January 2016.

For the Commission

The President

Jean-Claude JUNCKER

(1) OJ L 354, 31.12.2008, p. 34.

(2) OJ L 354, 31.12.2008, p. 1.

(4) EFSA Journal 2014; 11(12):3911.

(5) EFSA Journal 2014; 11(4):3188.

(6) EFSA Journal 2013; 11(10):3404.

ANNEX

Part A of Annex I to Regulation (EC) No 1334/2008 is amended as follows:

(1)

The entry concerning FL-no 07.041 is replaced by the following:

‘07.041

beta-Isomethylionone

79-89-0

650

Mixture of E/Z isomers (50-70 % (E) and 30-50 % (Z))

EFSA’

(2)

The entry concerning FL-no 07.099 is replaced by the following:

‘07.099

6-Methylhepta-3,5-dien-2-one

1604-28-0

1134

11143

Mixture of E/Z stereoisomers: 60-90 % (E)

EFSA’

(3)

The entry concerning FL-no 07.101 is replaced by the following:

‘07.101

4-Methylpent-3-en-2-one

141-79-7

1131

11853

EFSA’

(4)

The entry concerning FL-no 07.224 is replaced by the following:

‘07.224

trans-1-(2,6,6-Trimethyl-1-cyclohexen-1-yl)but-2-en-1-one

23726-91-2

At least 90 %; secondary components 2-4 % alpha-damascone and 2-4 % delta-damascone

EFSA’

(5)

The entry concerning FL-no 16.126 is replaced by the following:

‘16.126

3-[(4-amino-2,2-dioxido-1H-2,1,3-benzothiadiazin-5-yl)oxy]-2,2-dimethyl-N-propylpropanamide

1093200-92-0

2082

Restrictions for use as a flavouring substance:

In category 1 — not more than 3 mg/kg.

In category 3 — not more than 5 mg/kg.

In category 5 — not more than 15 mg/kg.

In category 5.3 — not more than 30 mg/kg.

In category 5.4 — not more than 10 mg/kg.

In category 6.3 — not more than 15 mg/kg.

In category 7 — not more than 10 mg/kg.

In category 12 — not more than 10 mg/kg.

In category 14.1 — not more than 5 mg/kg.

In category 16, excluding products covered in categories 1, 3 and 4 — not more than 5 mg/kg.

EFSA’

20.1.2016

Official Journal of the European Union

L 13/46

COMMISSION REGULATION (EU) 2016/56

of 19 January 2016

amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of extracts of rosemary (E 392) in spreadable fats

(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 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (1), and in particular Article 10(3) thereof,

Whereas:

(1)	Annex II to Regulation (EC) No 1333/2008 lays down a Union list of food additives approved for use in food and their conditions of use.

(2)	That list may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008 of the European Parliament and of the Council (2), either on the initiative of the Commission or following an application.

(3)

On 18 April 2013 an application was submitted for the authorisation of the use of extracts of rosemary (E 392) as an antioxidant in spreadable fats, i.e. in foods falling under the food category 02.2.2 of Annex II to Regulation (EC) No 1333/2008. The application was subsequently made available to the Member States pursuant to Article 4 of Regulation (EC) No 1331/2008.

(4)

According to the application the use of extracts of rosemary (E 392) is required to keep the quality and stability of spreadable fats with a fat content less than 80 % where content of polyunsaturated fatty acids is higher than 15 % w/w of the total fatty acid and/or where content of fish oil or algal oil is higher than 2 % w/w of the total fatty acid by protecting them against deterioration caused by oxidation.

(5)

On 7 March 2008 the European Food Safety Authority (‘the Authority’) adopted an opinion (3) on the use of rosemary extracts as a food additive. Based on the margins of safety identified using the NOAELs (4) from the different studies, in which generally the NOAELs were the highest dose levels tested, and using the conservative dietary exposure estimates it was concluded that the use of the rosemary extracts described in that scientific opinion at the proposed uses and use levels would not be of safety concern. The use of extracts of rosemary (E 392) in spreadable fats was not included in the opinion.

(6)

On 7 May 2015 the Authority issued an opinion (5) on the extension of use of extracts of rosemary (E 392) in spreadable fats. The assessment took into account the consumption of fat emulsions with a fat content less than 80 %. The Authority concluded that the proposed extension of use would not change the estimated exposure to the food additive, compared with the already approved permitted uses, and that the conclusions of the opinion of 7 March 2008 remain valid.

(7)	For that reason, it is appropriate to authorise the use of extracts of rosemary (E 392) as an antioxidant in spreadable fats with a fat content less than 80 %, food category 02.2.2 of Annex II to Regulation (EC) No 1333/2008.

(8)	Therefore, Annex II to Regulation (EC) No 1333/2008 should be amended accordingly.

(9)	The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Annex II to Regulation (EC) No 1333/2008 is amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the twentieth 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, 19 January 2016.

For the Commission

The President

Jean-Claude JUNCKER

(1) OJ L 354, 31.12.2008, p. 16.

(2) Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (OJ L 354, 31.12.2008, p. 1).

(3) EFSA Journal (2008) 721, 1-29.

(4) NOAEL (no observed adverse effect level) — dose or concentration of a substance tested at which no adverse effect is found.

(5) EFSA Journal 2015;13(5):4090.

ANNEX

Part E of Annex II to Regulation (EC) No 1333/2008, food category 02.2.2 ‘Other fat and oil emulsions including spreads as defined by Council Regulation (EC) No 1234/2007 and liquid emulsions’ is amended as follows:

(a)

the following entry is inserted after the entry for food additive E 385:

‘E 392

Extracts of rosemary

100

(41) (46)

only spreadable fats with a fat content less than 80 %’

(b)

the following footnotes are added after footnote (4):

‘(41):

Expressed on fat basis

(46):

As the sum of carnosol and carnosic acid’

20.1.2016

Official Journal of the European Union

L 13/49

COMMISSION IMPLEMENTING REGULATION (EU) 2016/57

of 19 January 2016

amending Annex I to Regulation (EC) No 798/2008 as regards the entry for the United States in the list of third countries, territories, zones or compartments from which poultry and poultry products may be imported into or transit through the Union in relation to highly pathogenic avian influenza outbreaks in the State of Minnesota

(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, point 4 of Article 8 and Article 9(4)(c) 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), 24(2) and 25(2) thereof,

Whereas:

(1)

Commission Regulation (EC) No 798/2008 (3) lays down veterinary certification requirements for imports into and transit, including storage during transit, through the Union of poultry and poultry products (‘the commodities’). It provides that the commodities may only be imported into and transit through the Union from the third countries, territories, zones or compartments listed in columns 1 and 3 of the table in Part 1 of Annex I thereto.

(2)	Regulation (EC) No 798/2008 also lays down the conditions for a third country, territory, zone or compartment to be considered as free from highly pathogenic avian influenza (HPAI).

(3)

The United States is listed in Part 1 of Annex I to Regulation (EC) No 798/2008 as a third country from which imports into and transit through the Union of the commodities covered by that Regulation are authorised from certain parts of its territory, depending on the presence of HPAI outbreaks. That regionalisation was recognised by Regulation (EC) No 798/2008, as amended by Implementing Regulations (EU) 2015/243 (4), (EU) 2015/342 (5), (EU) 2015/526 (6), (EU) 2015/796 (7), (EU) 2015/1153 (8), (EU) 2015/1220 (9), (EU) 2015/1363 (10) and (EU) 2015/1884 (11), following outbreaks of HPAI in that third country.

(4)	An Agreement between the Union and the United States (12) provides for a swift mutual recognition of regionalisation measures in the event of outbreaks of a disease in the Union or in the United States (‘the Agreement’).

(5)

Following each HPAI outbreak, the United States has implemented a stamping-out policy in order to control HPAI and to limit its spread. The veterinary authorities of the United States suspended issuing veterinary certificates for consignments of commodities intended for export to the Union from the entire territory of the affected States or from parts thereof which have been placed under veterinary restrictions and which are subject to Union regionalisation measures.

(6)

Since mid-June 2015, no further outbreaks of HPAI have been detected in the United States. There are no longer veterinary restrictions in place for imports into the Union of commodities referred to in column 4 of the table in Part 1 of Annex I to Regulation (EC) No 798/2008 for the whole territory of the United States, except for the State of Minnesota. The last HPAI outbreak on a poultry holding in Minnesota was detected on 5 June 2015. On 24 November 2015, the United States submitted updated information to the Commission on the epidemiological situation in Minnesota and the measures it has taken to prevent the spread of HPAI, including stamping-out operations for infected poultry flocks and for flocks on poultry holdings that were considered as dangerous contact premises.

(7)

In addition, the United States has reported the completion of cleaning and disinfection measures following the stamping-out operations undertaken on poultry holdings in Minnesota. It also reported that the required surveillance for avian influenza, carried out during the three month period following the completion of the stamping-out operations after the last HPAI outbreak in Minnesota was finalised by 10 September 2015, with favourable results.

(8)

The information provided by the United States has now been evaluated by the Commission. On the basis of that evaluation, as well as the commitments laid down in the Agreement and the guarantees provided by the United States, it is appropriate to lift the restrictions on the introduction into the Union of commodities referred to above from the State of Minnesota and to indicate the date as of when that State may again be considered free of HPAI and imports into the Union of commodities originating from Minnesota should again be authorised.

(9)	The entry for the United States in the list in Part 1 of Annex I to Regulation (EC) No 798/2008 should therefore be amended to take account of the current epidemiological situation in Minnesota. Annex I to Regulation (EC) No 798/2008 should therefore be amended accordingly.

(10)	The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Part 1 of Annex I to Regulation (EC) No 798/2008 is amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the third 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, 19 January 2016.

For the Commission

The President

Jean-Claude JUNCKER

(1) OJ L 18, 23.1.2003, p. 11.

(2) OJ L 343, 22.12.2009, p. 74.

(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 (OJ L 226, 23.8.2008, p. 1).

(4) Commission Implementing Regulation (EU) 2015/243 of 13 February 2015 amending Annex I to Regulation (EC) No 798/2008 as regards the entry for the United States in the list of third countries, territories, zones or compartments from which certain poultry commodities may be imported into or transit through the Union in relation to highly pathogenic avian influenza (OJ L 41, 17.2.2015, p. 5).

(5) Commission Implementing Regulation (EU) 2015/342 of 2 March 2015 amending Annex I to Regulation (EC) No 798/2008 as regards the entry for the United States in the list of third countries, territories, zones or compartments from which certain poultry commodities may be imported into or transit through the Union in relation to highly pathogenic avian influenza following outbreaks in the States of Idaho and California (OJ L 60, 4.3.2015, p. 31).

(6) Commission Implementing Regulation (EU) 2015/526 of 27 March 2015 amending Annex I to Regulation (EC) No 798/2008 as regards the entry for the United States in the list of third countries, territories, zones or compartments from which certain poultry commodities may be imported into or transit through the Union in relation to further outbreaks of highly pathogenic avian influenza in that country (OJ L 84, 28.3.2015, p. 30).

(7) Commission Implementing Regulation (EU) 2015/796 of 21 May 2015 amending Annex I to Regulation (EC) No 798/2008 as regards the entry for the United States in the list of third countries, territories, zones or compartments from which certain poultry commodities may be imported into or transit through the Union in relation to highly pathogenic avian influenza following further outbreaks in that country (OJ L 127, 22.5.2015, p. 9).

(8) Commission Implementing Regulation (EU) 2015/1153 of 14 July 2015 amending Annex I to Regulation (EC) No 798/2008 as regards the entry for the United States in the list of third countries, territories, zones or compartments from which certain poultry commodities may be imported into or transit through the Union in relation to highly pathogenic avian influenza following further outbreaks in that country (OJ L 187, 15.7.2015, p. 10).

(9) Commission Implementing Regulation (EU) 2015/1220 of 24 July 2015 amending Annex I to Regulation (EC) No 798/2008 as regards the entry for the United States in the list of third countries, territories, zones or compartments from which certain poultry commodities may be imported into or transit through the Union in relation to highly pathogenic avian influenza following recent outbreaks in the States of Indiana and Nebraska (OJ L 197, 25.7.2015, p. 1).

(10) Commission Implementing Regulation (EU) 2015/1363 of 6 August 2015 amending Annex I to Regulation (EC) No 798/2008 as regards the entry for the United States in the list of third countries, territories, zones or compartments from which certain poultry commodities may be imported into or transit through the Union in relation to highly pathogenic avian influenza outbreaks in that country (OJ L 210, 7.8.2015, p. 24).

(11) Commission Implementing Regulation (EU) 2015/1884 of 20 October 2015 amending Annex I to Regulation (EC) No 798/2008 as regards the entries for Canada and the United States in the list of third countries, territories, zones or compartments from which poultry and poultry products may be imported into or transit through the Union in relation to highly pathogenic avian influenza outbreaks in these countries (OJ L 276, 21.10.2015, p. 28).

(12) Agreement between the European Community and the Government of the United States of America on sanitary measures to protect public and animal health in trade in live animals and animal products, as approved on behalf of the European Community by Council Decision 1998/258/EC (OJ L 118, 21.4.1998, p. 1).

ANNEX

In Part 1 of Annex I to Regulation (EC) No 798/2008, the entry for the code US-2.10 concerning the State of Minnesota of the United States is replaced by the following:

ISO code and name of third country or territory	Code of third country, territory, zone or compartment	Description of third country, territory, zone or compartment	Veterinary certificate		Specific conditions	Specific conditions		Avian influenza surveillance status	Avian influenza vaccination status	Salmonella control status
			Model(s)	Additional guarantees		Closing date (1)	Opening date (2)
1	2	3	4	5	6	6A	6B	7	8	9
‘US — United States	US-2.10	State of Minnesota	WGM	VIII	P2	5.3.2015	10.9.2015
			POU, RAT		N P2
			BPR, BPP, DOC, DOR, HEP, HER, SRP, SRA, LT20					A		S3, ST1’

20.1.2016

Official Journal of the European Union

L 13/53

COMMISSION IMPLEMENTING REGULATION (EU) 2016/58

of 19 January 2016

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 Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (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, 19 January 2016.

For the Commission,

On behalf of the President,

Jerzy PLEWA

Director-General for Agriculture and Rural Development

(1) OJ L 347, 20.12.2013, p. 671.

(2) OJ L 157, 15.6.2011, p. 1.

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	MA	78,3
	TN	120,2
	TR	100,8
	ZZ	99,8
0707 00 05	MA	86,0
	TR	158,1
	ZZ	122,1
0709 93 10	MA	57,3
	TR	150,5
	ZZ	103,9
0805 10 20	EG	49,6
	MA	65,6
	TR	67,5
	ZZ	60,9
0805 20 10	IL	163,3
	MA	84,3
	ZZ	123,8
0805 20 30, 0805 20 50, 0805 20 70, 0805 20 90	IL	120,6
	JM	147,2
	MA	82,8
	TR	98,8
	ZZ	112,4
0805 50 10	MA	92,2
	TR	91,3
	ZZ	91,8
0808 10 80	CL	85,6
	US	121,1
	ZZ	103,4
0808 30 90	CN	76,1
0808 30 90	ZZ	76,1

(1) Nomenclature of countries laid down by Commission Regulation (EU) No 1106/2012 of 27 November 2012 implementing Regulation (EC) No 471/2009 of the European Parliament and of the Council on Community statistics relating to external trade with non-member countries, as regards the update of the nomenclature of countries and territories (OJ L 328, 28.11.2012, p. 7). Code ‘ZZ’ stands for ‘of other origin’.

20.1.2016

Official Journal of the European Union

L 13/55

COMMISSION IMPLEMENTING REGULATION (EU) 2016/59

of 19 January 2016

fixing the allocation coefficient to be applied to the quantities covered by the applications for import licences lodged from 1 to 7 January 2016 under the tariff quotas opened by Regulation (EC) No 341/2007 for garlic

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Whereas:

(1)	Commission Regulation (EC) No 341/2007 (2) opened annual tariff quotas for imports of garlic.

(2)

The quantities covered by the applications for ‘A’ import licences lodged in the first seven calendar days of January 2016, for the subperiod from 1 March 2016 to 31 May 2016, for certain quotas, exceed those available. The extent to which ‘A’ import licences may be issued should therefore be determined by establishing the allocation coefficient to be applied to the quantities requested, calculated in accordance with Article 7(2) of Commission Regulation (EC) No 1301/2006 (3).

(3)	In order to ensure the efficient management of the measure, 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 quantities covered by the applications for ‘A’ import licences lodged under Regulation (EC) No 341/2007 for the subperiod from 1 March 2016 to 31 May 2016 shall be multiplied by the allocation coefficient set out 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, 19 January 2016.

For the Commission,

On behalf of the President,

Jerzy PLEWA

Director-General for Agriculture and Rural Development

(1) OJ L 347, 20.12.2013, p. 671.

(2) Commission Regulation (EC) No 341/2007 of 29 March 2007 opening and providing for the administration of tariff quotas and introducing a system of import licences and certificates of origin for garlic and certain other agricultural products imported from third countries (OJ L 90, 30.3.2007, p. 12).

(3) Commission Regulation (EC) No 1301/2006 of 31 August 2006 laying down common rules for the administration of import tariff quotas for agricultural products managed by a system of import licences (OJ L 238, 1.9.2006, p. 13).

ANNEX

Origin

Reference number

Allocation coefficient — applications lodged for the subperiod from 1 March 2016 to 31 May 2016

(%)

Argentina

—	Traditional importers

09.4104

—

—	New importers

09.4099

—

China

—	Traditional importers

09.4105

62,826891

—	New importers

09.4100

0,466998

Other third countries

—	Traditional importers

09.4106

—

—	New importers

09.4102

—

20.1.2016

Official Journal of the European Union

L 13/57

Corrigendum to Directive 2014/32/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of measuring instruments

( Official Journal of the European Union L 96 of 29 March 2014 )

On page 163, Article 30(1):

for:

‘1. An accredited in-house body may be used to carry out conformity assessment activities for the undertaking of which it forms a part for the purpose of implementing the procedures set out in point 2 (Module A2) and point 5 (Module C2) of Annex II. That body shall constitute a separate and distinct part of the undertaking and shall not participate in the design, production, supply, installation, use or maintenance of the measuring instruments it assesses.’,

read:

‘1. An accredited in-house body may be used to carry out conformity assessment activities for the undertaking of which it forms a part for the purpose of implementing the procedures set out in Module A2 and Module C2 of Annex II. That body shall constitute a separate and distinct part of the undertaking and shall not participate in the design, production, supply, installation, use or maintenance of the measuring instruments it assesses.’;

on page 206, Annex IV, Part I, point 4.1:

for:

‘4.1.

Class 1,5 $3’,

read:

‘4.1.

Class 1,5 meters’;

on page 207, Annex IV, Part I, point 4.2:

for:

‘4.2.

Class 1,0 $3’,

read:

‘4.2.

Class 1,0 meters’;

on page 208, Annex IV, Part III, point 10(a) and (b):

for:

‘10.

(a)	Where a Member State imposes measurement of residential use, it shall allow such measurement to be performed by means of any Class 1,5 $3, and by Class 1,0 $3 which have a Qmax/Qmin ratio equal or greater than 150.

(b)	Where a Member State imposes measurement of commercial and/or light industrial use, it shall allow such measurement to be performed by any Class 1,5 USD 3.’,

read:

‘10.

(a)	Where a Member State imposes measurement of residential use, it shall allow such measurement to be performed by means of any Class 1,5 meter, and by Class 1,0 meters which have a Qmax/Qmin ratio equal or greater than 150.

(b)	Where a Member State imposes measurement of commercial and/or light industrial use, it shall allow such measurement to be performed by any Class 1,5 meter.’;

on page 215, Annex VI, point 7.5, table, second column, sixth row:

for:

‘Type identification (e.g. Pt 100)’,

read:

‘Type identification (e.g. Pt100)’.

		ISSN 1977-0677
Official Journal of the European Union		L 13

English edition	Legislation	Volume 59 20 January 2016

Contents		II Non-legislative acts	page
		INTERNATIONAL AGREEMENTS
	*	Information concerning the entry into force of the Agreement for scientific and technological cooperation between the European Union and the Faroe Islands associating the Faroe Islands to Horizon 2020 — the Framework Programme for Research and Innovation (2014-2020)	1
		REGULATIONS
	*	Council Regulation (Euratom) 2016/52 of 15 January 2016 laying down maximum permitted levels of radioactive contamination of food and feed following a nuclear accident or any other case of radiological emergency, and repealing Regulation (Euratom) No 3954/87 and Commission Regulations (Euratom) No 944/89 and (Euratom) No 770/90	2
	*	Commission Regulation (EU) 2016/53 of 19 January 2016 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for diethofencarb, mesotrione, metosulam and pirimiphos-methyl in or on certain products ( 1 )	12
	*	Commission Regulation (EU) 2016/54 of 19 January 2016 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards inclusion of gamma-glutamyl-valyl-glycine in the Union list of flavouring substances ( 1 )	40
	*	Commission Regulation (EU) 2016/55 of 19 January 2016 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards certain flavouring substances ( 1 )	43
	*	Commission Regulation (EU) 2016/56 of 19 January 2016 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of extracts of rosemary (E 392) in spreadable fats ( 1 )	46
	*	Commission Implementing Regulation (EU) 2016/57 of 19 January 2016 amending Annex I to Regulation (EC) No 798/2008 as regards the entry for the United States in the list of third countries, territories, zones or compartments from which poultry and poultry products may be imported into or transit through the Union in relation to highly pathogenic avian influenza outbreaks in the State of Minnesota ( 1 )	49
		Commission Implementing Regulation (EU) 2016/58 of 19 January 2016 establishing the standard import values for determining the entry price of certain fruit and vegetables	53
		Commission Implementing Regulation (EU) 2016/59 of 19 January 2016 fixing the allocation coefficient to be applied to the quantities covered by the applications for import licences lodged from 1 to 7 January 2016 under the tariff quotas opened by Regulation (EC) No 341/2007 for garlic	55

		Corrigenda
	*	Corrigendum to Directive 2014/32/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of measuring instruments ( OJ L 96, 29.3.2014 )	57