(1)

Commission Directive 2006/141/EC (2) lays down harmonised rules on infant formula and follow-on formula in the framework of Directive 2009/39/EC of the European Parliament and of the Council (3).

(2)

Directives 2009/39/EC and 2006/141/EC are repealed by Regulation (EU) No 609/2013. That Regulation lays down general compositional and information requirements for different categories of food, including infant formula and follow-on formula. The Commission has to adopt specific compositional and information requirements for infant formula and follow-on formula, taking into account the provisions of Directive 2006/141/EC.

(3)

Infant formula is the only processed foodstuff which wholly satisfies the nutritional requirements of infants during the first months of life until the introduction of appropriate complementary feeding. In order to safeguard the health of those infants, it is necessary to ensure that infant formula is the only product marketed as suitable for such use during that period.

(4)

The essential composition of infant formula and follow-on formula must satisfy the nutritional requirements of infants in good health as established by generally accepted scientific data.

(5)

Infant formula and follow-on formula are sophisticated products that are specially formulated for a vulnerable group of consumers. In order to ensure the safety and suitability of such products, detailed requirements should be laid down on the composition of infant formula and follow-on formula, including requirements on energy value, macronutrient and micronutrient content. These requirements should be based on the latest scientific advice of the European Food Safety Authority (‘the Authority’) in its opinion on the essential composition of infant and follow-on formulae (4).

(6)

In order to ensure innovation and product development, the voluntary addition to infant formula and follow-on formula of ingredients not covered by specific requirements of this Regulation should be possible. All ingredients used in the manufacture of infant formula and follow-on formula should be suitable for infants and their suitability should have been demonstrated, when necessary, by appropriate studies. It is the responsibility of food business operators to demonstrate such suitability and of national competent authorities to consider, on a case-by-case basis, whether this is the case. Guidance on the design and conduct of appropriate studies has been published by expert scientific groups such as the Scientific Committee on Food, the UK Committee on the Medical Aspects of Food and Nutrition Policy, and the European Society for Paediatric Gastroenterology, Hepatology and Nutrition. Such guidance should be taken into consideration in the manufacturing of infant formula or follow-on formula.

(7)

Pursuant to Regulation (EU) No 609/2013, the Commission has to adopt provisions restricting or prohibiting the use of pesticides and on pesticide residues in infant formula and follow-on formula, taking account of those currently established in the Annexes to Directive 2006/141/EC. Adopting provisions that are in line with the current scientific knowledge requires a significant amount of time, given that a comprehensive evaluation has to be carried out by the Authority on a number of aspects, including the appropriateness of the toxicological reference values for infants and young children. Taking into account the date of 20 July 2015 set by Regulation (EU) No 609/2013 for the adoption of this Delegated Regulation, the relevant existing requirements of Directive 2006/141/EC should, at this stage, be taken over. However, it is appropriate to use the terminology of Regulation (EC) No 1107/2009 of the European Parliament and of the Council (5).

(8)

Directive 2006/141/EC lays down specific requirements on the use of pesticides in products intended for the production of infant formula and follow-on formula and on pesticide residues in such food, based on two opinions given by the Scientific Committee for Food (SCF) on 19 September 1997 (6) and 4 June 1998 (7).

(9)

A very low residue limit of 0,01 mg/kg for all pesticides is set on the basis of the precautionary principle. In addition, more severe limitations are set for a small number of pesticides or metabolites of pesticides for which even a maximum residue level (MRL) of 0,01 mg/kg might, under worst-case intake conditions, lead to an exposure exceeding the acceptable daily intake (ADI) for infants and young children.

(10)

A prohibition of the use of certain pesticides would not necessarily guarantee that infant formula and follow-on formula are free from those pesticides, since some pesticides are persistent in the environment and their residues can be found in the food. For that reason, those pesticides are considered not to have been used if residues are below a certain level.

(11)

Infant formula and follow-on formula have to comply with Regulation (EU) No 1169/2011 of the European Parliament and of the Council (8). In order to take account of the specific nature of infant formula and follow-on formula and in order to promote and protect breast feeding, this Regulation should lay down additions and exceptions to those general rules, where appropriate.

(12)

Given the particular role of infant formula and follow-on formula in the diet of infants, it is important to ensure that products exported to third countries provide food information in a language easily understood by parents and caregivers, in the absence of specific relevant provisions established by or agreed with the importing country.

(13)

Given the different role of infant formula and follow-on formula in the diet of infants, it is appropriate to lay down provisions requiring that a clear distinction can be made between them, so as to avoid any risk of confusion.

(14)

The nutrition declaration for infant formula and follow-on formula is essential in order to guarantee their appropriate use, both for parents and caregivers and for health care professionals who recommend their consumption. For that reason and in order to provide more complete information, the nutrition declaration should include more particulars than those required by Regulation (EU) No 1169/2011. In addition, the exemption provided for in point 18 of Annex V to Regulation (EU) No 1169/2011 should not apply and the nutrition declaration should be mandatory for all infant formula and follow-on formula, irrespective of the package or container size.

(15)

Article 30(2) of Regulation (EU) No 1169/2011 contains a limited list of nutrients that may be included on a voluntary basis in the nutrition declaration for food. That Article does not cover all the substances that may be added to infant formula and follow-on formula. In order to ensure legal clarity, it should be laid down explicitly that the nutrition declaration for infant formula and follow-on formula may include such substances. In addition, in certain cases, more detailed information on protein, carbohydrate and fat present in the product could provide additional useful information for parents, caregivers and healthcare professionals. Food business operators should therefore be allowed to provide such information on a voluntary basis.

(16)

In order to facilitate product comparisons, the nutrition declaration for infant formula and follow-on formula should be expressed per 100 ml of the product ready for use after preparation in accordance with the manufacturer's instructions.

(17)

Infant formula is a food intended for use by infants during the first months of life and satisfying by itself the nutritional requirements of such infants until the introduction of appropriate complementary feeding. The expression of nutrition information on the energy value and the amount of nutrients of infant formula as a percentage of daily reference intake values would mislead consumers and should therefore not be allowed. Follow-on formula is, on the contrary, a food intended for use by infants when appropriate complementary feeding is introduced and which constitutes the principal liquid element in a progressively diversified diet of such infants. For that reason, and in order to ensure comparisons with other foods that can be included in the diet of such infants, the expression of nutrition information for follow-on formula as a percentage of daily reference intake values should be allowed. Given that healthy infants have different nutritional needs than adults, the use of daily reference intake values set out for the general adult population in Regulation (EU) No 1169/2011 would mislead consumers and should therefore not be allowed. For follow-on formula it should only be allowed to express nutrition information as a percentage of specific reference intakes that are appropriate for the age group.

(18)

Nutrition and health claims are promotional tools that are used on a voluntary basis by food business operators in commercial communication, in line with the rules of Regulation (EC) No 1924/2006 of the European Parliament and of the Council (9). Given the particular role of infant formula in the diet of infants, the use of nutrition and health claims should not be allowed for infant formula.

(19)

Statements relating to the presence or absence of lactose in infant formula and follow-on formula can provide useful information to parents and caregivers. Therefore, it is appropriate to lay down rules on such statements, which might be reviewed taking account of future developments on the market.

(20)

The mandatory addition of docosahexaenoic acid (DHA) to infant formula and follow-on formula is a new requirement introduced by this Regulation, as recently recommended by the Authority in its opinion on the essential composition of infant and follow-on formulae. Given that the addition of DHA was allowed on a voluntary basis under Directive 2006/141/EC, and parents and caregivers are familiar with the nutrition claim about the presence of DHA in infant formula, the use of which was permitted under that Directive, food business operators should be allowed to continue to refer to the presence of DHA in infant formula by a statement provided for in this Regulation for a limited period of time in order to avoid confusion. However, it is important that that statement provides full information to consumers about the mandatory presence of DHA in all infant formula products on the market.

(21)

The use of protein hydrolysates as a source of protein in infant formula and follow-on formula has been allowed under Directive 2006/141/EC for many years and the use of protein hydrolysates in the manufacturing of formula is widespread in the market. This is due, in particular, to the possibility, recognised by that Directive, to make a health claim on infant formula manufactured from protein hydrolysates describing the role of such formula in reducing the risk of developing allergy to milk proteins, under certain conditions laid down in that Directive. In its opinion on the essential composition of infant and follow-on formulae, the Authority noted that the safety and suitability of each specific formula containing protein hydrolysates has to be established by clinical evaluation and that only one formula containing partially hydrolysed whey protein has been positively evaluated so far. The Authority also noted that clinical studies are necessary to demonstrate if and to what extent a particular formula reduces the risk of developing short and long-term clinical manifestations of allergy in at-risk-infants who are not breast-fed. Taking into account the Authority's opinion, infant formula and follow-on formula manufactured from protein hydrolysates should only be allowed to be placed on the market if their composition corresponds to the requirements of this Regulation. Those requirements may be updated in order to allow the placing on the market of formula manufactured from protein hydrolysates with a composition different from the one already positively assessed, following a case-by-case evaluation of their safety and suitability by the Authority. In addition, after the assessment by the Authority, on the basis of studies, where it is demonstrated that a specific formula manufactured from protein hydrolysates reduces the risk of developing allergy to milk proteins, further consideration will be given to how to adequately inform parents and caregivers about that property of the product.

(22)

Regulation (EU) No 609/2013 provides that the labelling, presentation and advertising of infant formula and follow-on formula is to be designed so as not to discourage breastfeeding. There is scientific consensus that breast milk is the preferred food for healthy infants and the Union and its Member States are continuously committed to supporting breastfeeding. The conclusions adopted by the Council on nutrition and physical activity (10) invited Member States to promote and support adequate breastfeeding and welcomed the Member States' agreement on an EU Action Plan on Childhood Obesity 2014-2020, which includes a series of actions aimed at increasing breastfeeding rates in the Union. In this context, the EU Action Plan recognised the continuous importance of the World Health Organisation (WHO) International Code of Marketing of Breast-milk Substitutes, on which Directive 2006/141/EC was based. The WHO Code, adopted by the 34th World Health Assembly, aims at contributing to the provision of safe and adequate nutrition for infants, by the protection and promotion of breast-feeding, and by ensuring the proper use of breast-milk substitutes. It includes a series of principles related to, among others, marketing, information and responsibilities of health authorities.

(23)

In order to protect the health of infants, the rules laid down in this Regulation and in particular those on labelling, presentation and advertising, and promotional and commercial practices should continue being in conformity with the principles and the aims of the International Code of Marketing of Breast-milk Substitutes bearing in mind the particular legal and factual situation existing in the Union. In particular, evidence shows that advertising directly to the consumer and other marketing techniques influence parents and caregivers in their decisions on how to feed their infants. For this reason, and taking into account the particular role of infant formula in the diet of infants, specific restrictions should be laid down in this Regulation on advertising and other marketing techniques for this type of product. However, this Regulation should not concern the conditions of sale of publications specialising in baby care and of scientific publications.

(24)

In addition, information given on infant and young child feeding influences pregnant women, parents and caregivers when choosing the type of nourishment for children. It is therefore necessary to lay down requirements in order that such information ensures an adequate use of the products in question and is not counter to the promotion of breast feeding, in line with the principles of the WHO code.

(25)

Article 17(2) of Regulation (EC) No 178/2002 of the European Parliament and of the Council (11) requires Member States to enforce food law, and monitor and verify that the relevant requirements of food law are fulfilled by food and feed business operators at all stages of production, processing and distribution. In this context, in order to facilitate the efficient official monitoring of infant formula and follow-on formula, food business operators placing infant formula on the market should provide the national competent authorities with a model of the label used and all relevant information considered necessary to demonstrate compliance with this Regulation. A similar obligation should apply in respect of certain types of follow-on formula, unless Member States have a different efficient monitoring system.

(26)

In order to enable food business operators to adapt to the new requirements, this Regulation should apply from a date that is four years after its entry into force. Taking into account the number and importance of the new requirements applicable to infant formula and follow-on formula manufactured from protein hydrolysates, in respect of such products this Regulation should apply from a date that is five years after its entry into force,

(1)

Commission Directive 1999/21/EC (2) lays down harmonised rules on dietary foods for special medical purposes in the framework of Directive 2009/39/EC of the European Parliament and of the Council (3).

(2)

Directives 2009/39/EC and 1999/21/EC are repealed by Regulation (EU) No 609/2013. That Regulation lays down general compositional and information requirements for different categories of food, including food for special medical purposes. The Commission has to adopt specific compositional and information requirements for food for special medical purposes, taking into account the provisions of Directive 1999/21/EC.

(3)

Food for special medical purposes is developed in close cooperation with health care professionals to feed patients affected by or malnourished because of a specific diagnosed disease, disorder or medical condition that makes it impossible or very difficult for those patients to satisfy their nutritional needs through the consumption of other foods. For that reason, food for special medical purposes must be used under medical supervision, which may be applied with the assistance of other competent health professionals.

(4)

The composition of food for special medical purposes may differ substantially depending, among others, on the specific disease, disorder or medical condition for the dietary management of which the product is intended, on the age of the patients and the place in which they receive health care support, and the product's intended use. In particular, food for special medical purposes can be classified in different categories depending on whether its composition is standard or specifically nutrient-adapted for a disease, disorder or medical condition and on whether or not it constitutes the sole source of nourishment for the persons for whom it is intended.

(5)

Because of the wide diversity of food for special medical purposes, the rapidly evolving scientific knowledge on which it is based, and the need to ensure adequate flexibility to develop innovative products, it is not appropriate to lay down detailed compositional rules for such food products. It is however important to set principles and requirements specific to them in order to ensure that they are safe, beneficial and effective for the persons for whom they are intended on the basis of generally accepted scientific data.

(6)

In particular, the nutritional composition of food for special medical purposes developed to satisfy the nutritional requirements of infants should be based on that of infant formula and follow-on formula, in order to take into account the specificities of the nutritional requirements of infants. However, taking into account that infant formula and follow-on formula are intended for healthy infants, derogations should be provided for food for special medical purposes developed to satisfy the nutritional requirements of infants when this is necessary for the intended use of the product.

(7)

It is important to set basic rules concerning the content of vitamin and mineral substances in food for special medical purposes in order to ensure the free circulation of products which are different in composition and the protection of consumers. Such rules should be based on those of Directive 1999/21/EC, given that they have ensured an adequate framework for food for special medical purposes so far. Rules should include minimum and maximum amounts, in the case of products considered to be nutritionally complete for covering the nutritional requirements of the patient, and maximum amounts only, in the case of products considered to be nutritionally incomplete, without prejudice to modifications for one or more of these nutrients rendered necessary by the intended use of the product.

(8)

Pursuant to Regulation (EU) No 609/2013, the Commission has to adopt provisions restricting or prohibiting the use of pesticides and on pesticide residues in food for special medical purposes developed to satisfy the nutritional requirements of infants and young children. Adopting provisions that are in line with the current scientific knowledge requires a significant amount of time, given that a comprehensive evaluation has to be carried out by the European Food Safety Authority on a number of aspects, including the appropriateness of the toxicological reference values for infants and young children.

(9)

Directive 1999/21/EC does not lay down such provisions. Commission Directives 2006/125/EC (4) and 2006/141/EC (5), however, do currently lay down specific requirements in this respect for foods for healthy infants and young children, based on two opinions given by the Scientific Committee for Food (SCF) on 19 September 1997 (6) and 4 June 1998 (7).

(10)

Taking into account the date of 20 July 2015 set by Regulation (EU) No 609/2013 for the adoption of this Delegated Regulation, the relevant existing requirements of Directives 2006/125/EC and 2006/141/EC should, at this stage, be taken over. However, it is appropriate to use the terminology of Regulation (EC) No 1107/2009 of the European Parliament and of the Council (8).

(11)

A very low residue limit of 0,01 mg/kg for all pesticides is set on the basis of the precautionary principle. In addition, more severe limitations are set for a small number of pesticides or metabolites of pesticides for which even a maximum residue level (MRL) of 0,01 mg/kg might, under worst-case intake conditions, lead to an exposure exceeding the acceptable daily intake (ADI) for infants and young children.

(12)

A prohibition of the use of certain pesticides would not necessarily guarantee that food for special medical purposes developed to satisfy the nutritional requirements of infants and young children is free from those pesticides, since some pesticides are persistent in the environment and their residues can be found in the food. For that reason, those pesticides, are considered not to have been used if residues are below a certain level.

(13)

Food for special medical purposes has to comply with Regulation (EU) No 1169/2011 of the European Parliament and of the Council (9). In order to take account of the specific nature of food for special medical purposes, this Regulation should lay down additions and exceptions to those general rules, where appropriate.

(14)

Providing all information that is necessary to ensure the appropriate use of food for special medical purposes should be mandatory for this type of food. That information should include information on the properties and characteristics in relation to, among others, the special processing and formulation, nutritional composition and rationale of use of the product that make it useful for its specific intended purpose. Such information should not be considered as nutrition and health claims within the meaning of Regulation (EC) No 1924/2006 of the European Parliament and of the Council (10).

(15)

The nutrition declaration for food for special medical purposes is essential in order to guarantee its appropriate use, both for patients consuming that food and for health care professionals who recommend its consumption. For that reason and in order to provide more complete information to patients and healthcare professionals, the nutrition declaration should include more particulars than those required by Regulation (EU) No 1169/2011. In addition, the exemption provided for in point 18 of Annex V to Regulation (EU) No 1169/2011 should not apply and the nutrition declaration should be mandatory for all food for special medical purposes, irrespective of the package or container size.

(16)

Consumers of food for special medical purposes have different nutritional needs than the normal population. The expression of nutrition information on the energy value and the amount of nutrients of food for special medical purposes as a percentage of daily reference intake values set out in Regulation (EU) No 1169/2011 would mislead consumers and should therefore not be allowed.

(17)

The use of nutrition and health claims authorised under Regulation (EC) No 1924/2006 to promote food for special medical purposes would not be appropriate, since consumers of such products are patients suffering from a disease, disorder or condition and are, therefore, not part of the general healthy population. In addition, food for special medical purposes is to be used under medical supervision and its consumption should not be promoted through the use of nutrition and health claims directly targeting consumers. For those reasons, the use of nutrition and health claims should not be allowed for food for special medical purposes.

(18)

In the past years, an increasing number of products have been placed on the market as food for special medical purposes developed to satisfy the nutritional requirements of infants. These products are sometimes promoted with means directly targeting consumers that are not subject to the restrictions under Union legislation applicable to infant formula and follow-on formula. In order to avoid possible abuses linked to the misclassification of products, reduce confusion for consumers on the nature of the different products being offered to them and guarantee conditions of fair competition, it seems appropriate to introduce additional restrictions on the labelling, presentation, advertising, and promotional and commercial practices of food for special medical purposes developed to satisfy the nutritional requirements of infants. Those restrictions should be similar to those applicable to infant formula and follow-on formula for healthy infants, with adjustments taking into account the intended use of the product and without prejudice to the need to provide food information to patients and health care professionals to ensure the product's appropriate use. Given that food for special medical purposes is to be used under medical supervision, those restrictions should not make it more difficult for food business operators to communicate with health care professionals and should allow health care professionals to assess the suitability of different products for their intended use.

(19)

Article 17(2) of Regulation (EC) No 178/2002 of the European Parliament and of the Council (11) requires Member States to enforce food law, and monitor and verify that the relevant requirements of food law are fulfilled by food and feed business operators at all stages of production, processing and distribution. In this context, in order to facilitate the efficient official monitoring of food for special medical purposes, food business operators placing food for special medical purposes on the market should provide the national competent authorities with a model of the label used and all relevant information considered necessary to demonstrate compliance with this Regulation, unless Member States have a different efficient monitoring system.

(20)

In order to enable food business operators to adapt to the new requirements, this Regulation should apply from a date that is 3 years after its entry into force. Taking into account the number and importance of the new requirements applicable to food for special medical purposes developed to satisfy the nutritional requirements of infants, in respect of such products this Regulation should apply from a date that is 4 years after its entry into force,

(1)

Article 17 of Regulation (EC) No 470/2009 requires that the maximum residue limit (hereinafter ‘MRL’) for pharmacologically active substances intended for use in the Union in veterinary medicinal products for food-producing animals or in biocidal products used in animal husbandry is established in a Regulation.

(2)

Table 1 of the Annex to Commission Regulation (EU) No 37/2010 (2) sets out the pharmacologically active substances and their classification regarding MRLs in foodstuffs of animal origin.

(3)

Purified semi-solid extract from Humulus lupulus L. containing approximately 48 % of beta acids (as potassium salts) is not yet included in that table.

(4)

An application for the establishment of MRLs for purified semi-solid extract from Humulus lupulus L. containing approximately 48 % of beta acids (as potassium salts) in honey has been submitted to the European Medicines Agency (hereinafter ‘EMA’).

(5)

The EMA, based on the opinion of the Committee for Medicinal Products for Veterinary Use, has recommended that the establishment of an MRL for purified semi-solid extract from Humulus lupulus L. containing approximately 48 % of beta acids (as potassium salts) in honey, is not necessary for the protection of human health.

(6)

According to Article 5 of Regulation (EC) No 470/2009, the EMA is to consider using MRLs established for a pharmacologically active substance in a particular foodstuff for another foodstuff derived from the same species, or MRLs established for a pharmacologically active substance in one or more species for other species.

(7)

Given that residues in honey are not subject to the metabolic processes to which they may be subjected in other food commodities of animal origin, the EMA concluded that an extrapolation of the recommendation on MRL for purified semi-solid extract from Humulus lupulus L. containing approximately 48 % of beta acids (as potassium salts) is not appropriate.

(8)

Regulation (EU) No 37/2010 should therefore be amended accordingly.

(9)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products,

(1)

Annex IB to Regulation (EEC) No 3821/85 sets out the technical specifications for the construction, testing, installation and inspection of digital tachographs.

(2)

Commission Regulation (EC) No 68/2009 (2) introduced an adaptor as a temporary solution, until 31 December 2013, to make it possible to install tachographs in conformity with Annex IB to Regulation (EEC) No 3821/85 in M1 and N1 type vehicles.

(3)

Commission Regulation (EU) No 1161/2014 (3) amended Regulation (EEC) No 3821/85 in order to extend the period of validity of the adaptor until 31 December 2015.

(4)

Regulation (EEC) No 3821/85 has been replaced by Regulation (EU) No 165/2014 of the European Parliament and of the Council (4). However, in accordance with Article 46 of Regulation (EU) No 165/2014 the provisions of Regulation (EEC) No 3821/85, including Annex IB thereto, continue to apply, on a transitional basis, until the date of application of the implementing acts referred to in Regulation (EU) No 165/2014.

(5)

Recital 5 of Regulation (EU) No 165/2014 provides that the Commission will consider extending the period of validity of the adaptor for Ml and N1 vehicles until 2015 and give further consideration to a long-term solution for M1 and N1 vehicles before 2015.

(6)

The Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions ‘Digital tachograph: Roadmap for future activities’ (5), which accompanied the proposal for Regulation (EU) No 165/2014, foresees a time-frame of 2 years for the preparation and adoption of annexes and appendices, following the adoption of Regulation (EU) No 165/2014.

(7)

A permanent solution concerning the adaptor should be laid down in the technical specifications related to the implementation of Regulation (EU) No 165/2014. In application of the principle of legitimate expectation, the possibility to use adaptors in M1 and N1 type vehicles should therefore be extended at least until the adoption of those technical specifications by implementing acts.

(8)

The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 42 of Regulation (EU) No 165/2014,

In part I, Definitions, point (rr), first indent, the date of ‘ 31 December 2015 ’ is replaced by ‘ 31 December 2016 ’.

(1)

Commission Delegated Regulation (EU) No 1062/2014 (2) establishes a list of existing active substances to be evaluated for their possible approval for use in biocidal products. That list includes C(M)IT/MIT (3:1).

(2)

C(M)IT/MIT (3:1) has been evaluated in accordance with Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council (3) for use in product-type 2, private area and public health area disinfectants and other biocidal products, product-type 4, food and feed area disinfectants, product-type 6, in-can preservatives, product-type 11, preservatives for liquid-cooling and processing systems, product-type 12, slimicides, and product-type 13, metalworking-fluid preservatives, as defined in Annex V to that Directive, which correspond respectively to product-types 2, 4, 6, 11, 12 and 13 as defined in Annex V to Regulation (EU) No 528/2012.

(3)

France was designated as evaluating competent authority and submitted the assessment reports, together with its recommendations, to the Commission on 19 October 2011, 27 November 2012 and 22 April 2013 in accordance with paragraphs 4 and 6 of Article 14 of Commission Regulation (EC) No 1451/2007 (4).

(4)

In accordance with Article 7(1)(b) of Delegated Regulation (EU) No 1062/2014, the opinions of the European Chemicals Agency were formulated on 5 February 2015, 14 April 2015 and 17 June 2015 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority.

(5)

According to those opinions, biocidal products used for product-types 2, 4, 6, 11, 12 and 13 and containing C(M)IT/MIT (3:1) may be expected to satisfy the requirements of Article 5 of Directive 98/8/EC, provided that certain conditions concerning its use are complied with.

(6)

It is therefore appropriate to approve C(M)IT/MIT (3:1) for use in biocidal products for product-types 2, 4, 6, 11, 12 and 13 subject to compliance with certain specifications and conditions.

(7)

For the use in product-type 4, the evaluation did not address the incorporation of biocidal products containing C(M)IT/MIT (3:1) in materials and articles intended to come into contact directly or indirectly with food within the meaning of Article 1(1) of Regulation (EC) No 1935/2004 of the European Parliament and of the Council (5). Such materials may require the establishment of specific limits on the migration into food, as referred to in Article 5(1)(e) of that Regulation. The approval should therefore not cover such use unless the Commission has established such limits or it has been established pursuant to that Regulation that such limits are not necessary.

(8)

Since C(M)IT/MIT (3:1) meets the criteria for classification as skin sensitiser category 1 as defined in Annex I to Regulation (EC) No 1272/2008 of the European Parliament and of the Council (6), treated articles treated with or incorporating C(M)IT/MIT (3:1) should be appropriately labelled when placed on the market.

(9)

A reasonable period should be allowed to elapse before an active substance is approved, in order to permit interested parties to take the preparatory measures necessary to meet the new requirements.

(10)

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

(1)

Private storage aid granted pursuant to Commission Implementing Regulation (EU) 2015/2334 (2) has had a favourable effect on the pigmeat market. A further stabilisation of prices is expected.

(2)

The granting of private storage aid for pigmeat should therefore be ended and a closing date for the submission of applications should be set.

(3)

For the sake of legal certainty, Implementing Regulation (EU) 2015/2334 should be repealed.

(4)

In order to avoid speculation, this Regulation should enter into force on the day following that of its publication in the Official Journal of the European Union.

(5)

The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Common Organisation of Agricultural Markets,

(1)

Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto.

(2)

The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the Official Journal of the European Union,

(1)

Protocol 2 to the Stabilisation and Association Agreement between the European Communities and their Member States, of the one part, and Bosnia and Herzegovina, of the other part (1) (‘the Agreement’), concerns the definition of the concept of ‘originating products’ and methods of administrative cooperation.

(2)

The Regional Convention on pan-Euro-Mediterranean preferential rules of origin (2) (‘the Convention’) lays down provisions on the origin of goods traded under relevant agreements concluded between the Contracting Parties. Bosnia and Herzegovina and other participants in the Stabilisation and Association Process from the Western Balkans were invited to join the system of pan-European diagonal cumulation of origin in the Thessaloniki agenda, endorsed by the European Council of June 2003. They were invited to join the Convention by a decision of the Euro-Mediterranean Ministerial Conference of October 2007.

(3)

The Union and Bosnia and Herzegovina signed the Convention on 15 June 2011 and 24 September 2013 respectively.

(4)

The Union and Bosnia and Herzegovina deposited their instruments of acceptance with the depositary of the Convention on 26 March 2012 and 26 September 2014 respectively. Consequently, pursuant to Article 10(3) of the Convention, the Convention entered into force in relation to the Union and Bosnia and Herzegovina on 1 May 2012 and on 1 November 2014 respectively.

(5)

Article 6 of the Convention provides that each Contracting Party is to take appropriate measures to ensure that the Convention is effectively applied. To that effect, the Stabilisation and Association Council established by the Agreement should adopt a decision replacing Protocol 2 to the Agreement with a new protocol which, with regard to the rules of origin, refers to the Convention.

(6)

The position of the Union within the Stabilisation and Association Council should therefore be based on the attached draft decision,

(1)

The active substances flocoumafen, brodifacoum and warfarin were included into Annex I to Directive 98/8/EC of the European Parliament and of the Council (2) for use in biocidal products for product-type 14, and pursuant to Article 86 of Regulation (EU) No 528/2012 are considered approved under that Regulation subject to the specifications and conditions set out in Annex I to that Directive.

(2)

Their approval will expire on 30 September 2016 for flocoumafen and 31 January 2017 for brodifacoum and warfarin. In accordance with Article 13(1) of Regulation (EU) No 528/2012, applications have been submitted for the renewal of the approval of these active substances.

(3)

Because of the risks identified when using the active substances flocoumafen, brodifacoum and warfarin, the renewal of their approval is subject to an assessment of an alternative active substance or substances. In addition, due to those risks, the approval of those active substances may be renewed only if it is shown that at least one of the conditions of the first subparagraph of Article 5(2) of Regulation (EU) No 528/2012 is fulfilled.

(4)

The Commission has launched a study on the risk-mitigation measures that may be applied to anticoagulant rodenticides with a view to proposing the measures that are most suitable for mitigating the risks associated to the properties of those active substances.

(5)

The possibility should be given to the applicants for the renewal of approval of those active substances to address the conclusions of the study in their application. Furthermore, the conclusions of that study should be taken into account when deciding on the renewal of the approval of all anticoagulant rodenticides.

(6)

In order to facilitate the review and comparison of the risks and benefits of all anticoagulant rodenticides as well as of the risk-mitigation measures applied to them, the assessment of flocoumafen, brodifacoum and warfarin should be performed in parallel to the assessment of the other anticoagulant rodenticides.

(7)

Consequently, for reasons beyond the control of the applicants, the approval of flocoumafen, brodifacoum and warfarin is likely to expire before a decision has been taken on a possible renewal of their approval. It is, therefore, appropriate to postpone the expiry date of approval of those active substances for a period of time sufficient to enable the examination of the applications.

(8)

Except for the expiry date of the approval, those substances should remain approved subject to the specifications and conditions set out in Annex I to Directive 98/8/EC.

(9)

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

(1)

Tax treaties play an important role in encouraging cross-border trade efficiency by improving certainty for tax payers as regards their international dealings. By entering into a tax treaty the Contracting States agree to attribute the taxing rights between themselves with a view to eliminating double taxation and thereby fostering economic activity and growth. Tax treaties should not create opportunities for non- or reduced taxation through treaty shopping or other abusive strategies which only frustrate the purpose of such conventions and undermine the tax revenues of the Contracting States. The European Commission lends its full support to the efforts to tackle tax treaty abuse.

(2)

Following the release of the report ‘Addressing Base Erosion and Profit Shifting’ (BEPS) in February 2013, OECD and the G20 countries adopted a 15-point Action Plan to address BEPS in September 2013. As a result of the joint undertaking final reports on Actions 6 (preventing the granting of treaty benefits in inappropriate circumstances) and 7 (preventing the artificial avoidance of permanent establishment status) were published in October 2015. Both reports propose changes to the OECD Model Tax Convention and for the inclusion in the multilateral instrument implementing the results of the work on treaty issues by the end of 2016, as mandated by the OECD-G20 Project. Taken together, the changes proposed in the two reports are intended to enable countries to address their tax treaty related BEPS concerns.

(3)

The final report on Action 6 identifies tax treaty abuse, and in particular treaty shopping, as an important source of BEPS concerns and, proposes an approach based on different types of safeguards against such abuse of treaty provisions and a certain degree of flexibility regarding how to use them. In addition to suggesting a clarification that tax treaties are not intended to create opportunities for double non-taxation, the report recommends, inter alia, the inclusion in the multilateral instrument of a general anti-abuse rule based on a ‘principal purpose test’ (PPT) of transactions or arrangements.

(4)

The final report as regards Action 7 distinguishes in particular commissionaire arrangements and the exploitation of the specific exceptions to the definition of a permanent establishment (PE) as the most common strategies to artificially avoid taxable presence in the form of a PE. The commissionaire arrangements typically take advantage of the relatively formal approach of the current Article 5(5) of the OECD Model Tax Convention as regards conclusion of sales contracts. The specific exceptions to the definition of a PE applicable to activities of preparatory or auxiliary nature are, in addition to being vulnerable to abuse through strategies based on fragmented activities, ill-equipped to deal with business models of digital economy. The report therefore proposes changes to Article 5 of the OECD Model Tax Convention to make it more resilient against artificial structures to circumvent its application.

(5)

It is essential for the good functioning of the internal market that the Member States are able to operate efficient tax systems and prevent their tax bases from being unduly eroded because of inadvertent non-taxation and abuse and, that the solutions to protect their tax bases create no undue mismatches and market distortions.

(6)

It is equally vital that the measures the Member States make use of in order to implement the commitments they have taken under BEPS are in line with the agreed standards across the Union so as to provide legal certainty both for taxpayers as well as tax administrations.

(7)

With a view to ensuring compliance with EU law, the general anti-abuse rule based on a principal purpose test as suggested in the final report on Action 6 needs to be aligned with the case law of the Court of Justice of the European Union as regards the abuse of law.