# Official Journal L 30/2015

| | ISSN 1977-0677 |
| --- | --- |
| Official Journal
  of the European Union | L 30 |
| | |
| English edition | Legislation | Volume 586 February 2015 |

ISSN 1977-0677

Official Journal

of the European Union

L 30

English edition

Legislation

Volume 586 February 2015

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| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | INTERNATIONAL AGREEMENTS |
| | * | Information on the date of signature of the Protocol agreed between the European Union and the Republic of Guinea-Bissau setting out the fishing opportunities and the financial contribution provided for in the Fisheries Partnership Agreement between the two parties currently in force | 1 |
| | | REGULATIONS |
| | * | Commission Regulation (EU) 2015/174 of 5 February 2015 amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food (
  1
  ) | 2 |
| | * | Commission Implementing Regulation (EU) 2015/175 of 5 February 2015 laying down special conditions applicable to the import of guar gum originating in or consigned from India due to contamination risks by pentachlorophenol and dioxins (
  1
  ) | 10 |
| | * | Commission Implementing Regulation (EU) 2015/176 of 5 February 2015 Approving non-minor amendments to the specification for a name entered in the register of traditional specialities guaranteed [Prekmurska gibanica (TSG)] | 16 |
| | | Commission Implementing Regulation (EU) 2015/177 of 5 February 2015 establishing the standard import values for determining the entry price of certain fruit and vegetables | 17 |
| | | DECISIONS |
| | * | Council Decision (EU) 2015/178 of 27 January 2015 on the position to be taken on behalf of the European Union within the Sanitary and Phytosanitary Sub-Committee, the Customs Sub-Committee and the Geographical Indications Sub-Committee established by the Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and the Republic of Moldova, of the other part, as regards the adoption of decisions of the Sanitary and Phytosanitary Sub-Committee, the Customs Sub-Committee and the Geographical Indications Sub-Committee on their Rules of Procedure | 20 |
| | * | Commission Implementing Decision (EU) 2015/179 of 4 February 2015 authorising Member States to provide for a derogation from certain provisions of Council Directive 2000/29/EC in respect of wood packaging material of conifers (Coniferales) in the form of ammunition boxes originating in the United States of America under the control of the United States Department of Defence
  (notified under document C(2015) 445) | 38 |

Contents

II   Non-legislative acts

page

INTERNATIONAL AGREEMENTS

*

Information on the date of signature of the Protocol agreed between the European Union and the Republic of Guinea-Bissau setting out the fishing opportunities and the financial contribution provided for in the Fisheries Partnership Agreement between the two parties currently in force

Information on the date of signature of the Protocol agreed between the European Union and the Republic of Guinea-Bissau setting out the fishing opportunities and the financial contribution provided for in the Fisheries Partnership Agreement between the two parties currently in force

1

REGULATIONS

*

Commission Regulation (EU) 2015/174 of 5 February 2015 amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food (
  1
  )

1

2

*

Commission Implementing Regulation (EU) 2015/175 of 5 February 2015 laying down special conditions applicable to the import of guar gum originating in or consigned from India due to contamination risks by pentachlorophenol and dioxins (
  1
  )

1

10

*

Commission Implementing Regulation (EU) 2015/176 of 5 February 2015 Approving non-minor amendments to the specification for a name entered in the register of traditional specialities guaranteed [Prekmurska gibanica (TSG)]

16

Commission Implementing Regulation (EU) 2015/177 of 5 February 2015 establishing the standard import values for determining the entry price of certain fruit and vegetables

17

DECISIONS

*

Council Decision (EU) 2015/178 of 27 January 2015 on the position to be taken on behalf of the European Union within the Sanitary and Phytosanitary Sub-Committee, the Customs Sub-Committee and the Geographical Indications Sub-Committee established by the Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and the Republic of Moldova, of the other part, as regards the adoption of decisions of the Sanitary and Phytosanitary Sub-Committee, the Customs Sub-Committee and the Geographical Indications Sub-Committee on their Rules of Procedure

20

*

Commission Implementing Decision (EU) 2015/179 of 4 February 2015 authorising Member States to provide for a derogation from certain provisions of Council Directive 2000/29/EC in respect of wood packaging material of conifers (Coniferales) in the form of ammunition boxes originating in the United States of America under the control of the United States Department of Defence
  (notified under document C(2015) 445)

(notified under document C(2015) 445)

38

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| | (1)   Text with EEA relevance |

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(1)   Text with EEA relevance

1

| EN | Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.
  The titles of all other Acts are printed in bold type and preceded by an asterisk. |
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EN

Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.

The titles of all other Acts are printed in bold type and preceded by an asterisk.

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II Non-legislative acts

INTERNATIONAL AGREEMENTS

| 6.2.2015 | EN | Official Journal of the European Union | L 30/1 |
| --- | --- | --- | --- |

6.2.2015

EN

Official Journal of the European Union

L 30/1

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Information on the date of signature of the Protocol agreed between the European Union and the Republic of Guinea-Bissau setting out the fishing opportunities and the financial contribution provided for in the Fisheries Partnership Agreement between the two parties currently in force

On 24 November 2014, the Protocol agreed between the European Union and the Republic of Guinea-Bissau setting out the fishing opportunities and the financial contribution provided for in the Fisheries Partnership Agreement between the two parties currently in force was signed.

The Protocol applies provisionally from 24 November 2014, date of signature, in accordance with its Article 18.

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REGULATIONS

| 6.2.2015 | EN | Official Journal of the European Union | L 30/2 |
| --- | --- | --- | --- |

6.2.2015

EN

Official Journal of the European Union

L 30/2

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COMMISSION REGULATION (EU) 2015/174

of 5 February 2015

amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food

(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 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (1), and in particular points (a), (c), (d) and (e) of Article 5(1), Article 11(3) and Article 12(6) thereof,

Whereas:

| (1) | Annex I to Commission Regulation (EU) No 10/2011 (2) establishes a Union list of authorised substances (‘the Union list’) which may be used in the manufacture of plastic materials and articles. |
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(1)

Annex I to Commission Regulation (EU) No 10/2011 (2) establishes a Union list of authorised substances (‘the Union list’) which may be used in the manufacture of plastic materials and articles.

| (2) | Tartaric acid (food contact material (FCM) substance No 161) was assessed by the Scientific Committee for Foods (SCF) in 1991 (3). The SCF gave a favourable opinion only to the natural occurring form of tartaric acid (L-(+)-tartaric acid). It explicitly excluded the DL form of tartaric acid. It followed from the SCF assessment that only L-(+)-tartaric acid does not endanger human health, while this has not been shown for all other forms of that substance. Therefore, it should be clear from the name of the substance as included in Table 1 of Annex I to Regulation (EU) No 10/2011 that it refers only to L-(+)-tartaric acid. Therefore, the name of FCM substance No 161 should be amended accordingly. |
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(2)

Tartaric acid (food contact material (FCM) substance No 161) was assessed by the Scientific Committee for Foods (SCF) in 1991 (3). The SCF gave a favourable opinion only to the natural occurring form of tartaric acid (L-(+)-tartaric acid). It explicitly excluded the DL form of tartaric acid. It followed from the SCF assessment that only L-(+)-tartaric acid does not endanger human health, while this has not been shown for all other forms of that substance. Therefore, it should be clear from the name of the substance as included in Table 1 of Annex I to Regulation (EU) No 10/2011 that it refers only to L-(+)-tartaric acid. Therefore, the name of FCM substance No 161 should be amended accordingly.

| (3) | The European Food Safety Authority (the Authority) adopted an opinion re-evaluating the tolerable daily intake (TDI) of phenol (4). Phenol (FCM No 241) is included as a starting substance in Table 1 of Annex I to Regulation (EU) No 10/2011. The generic specific migration limit (SML) of 60 mg/kg set out in Article 11(2) of Regulation (EU) No 10/2011 applies to that substance. In the re-evaluation of phenol, the Authority reduced the TDI from 1,5 mg/kg body weight (‘bw’)/day to 0,5 mg/kg bw/day. The Authority noted that the exposure from all sources was above the TDI, while exposure from food contact materials was likely to be in the range of the TDI. In addition to the TDI, an allocation factor of 10 % for the exposure from food contact materials should be used to achieve a sufficient reduction in phenol exposure. The setting of the migration limit takes into account a conventional exposure assumption that 1 kg of food is consumed daily by a person of 60 kg body weight. Therefore, on the basis of the TDI, the allocation factor and the exposure assumption a specific migration limit of 3 mg/kg for phenol should be set to ensure that phenol does not endanger human health. |
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(3)

The European Food Safety Authority (the Authority) adopted an opinion re-evaluating the tolerable daily intake (TDI) of phenol (4). Phenol (FCM No 241) is included as a starting substance in Table 1 of Annex I to Regulation (EU) No 10/2011. The generic specific migration limit (SML) of 60 mg/kg set out in Article 11(2) of Regulation (EU) No 10/2011 applies to that substance. In the re-evaluation of phenol, the Authority reduced the TDI from 1,5 mg/kg body weight (‘bw’)/day to 0,5 mg/kg bw/day. The Authority noted that the exposure from all sources was above the TDI, while exposure from food contact materials was likely to be in the range of the TDI. In addition to the TDI, an allocation factor of 10 % for the exposure from food contact materials should be used to achieve a sufficient reduction in phenol exposure. The setting of the migration limit takes into account a conventional exposure assumption that 1 kg of food is consumed daily by a person of 60 kg body weight. Therefore, on the basis of the TDI, the allocation factor and the exposure assumption a specific migration limit of 3 mg/kg for phenol should be set to ensure that phenol does not endanger human health.

| (4) | 1,4-Butanediol formal (FCM No 344) was evaluated by the SCF in 2000 (5). The SCF concluded that a SML of 0,05 mg/kg should be set for that substance. Column 8 of Table 1 of Annex I to Regulation (EU) No 10/2011 incorrectly states that migration of the substance shall be non-detectable and should therefore be corrected. |
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(4)

1,4-Butanediol formal (FCM No 344) was evaluated by the SCF in 2000 (5). The SCF concluded that a SML of 0,05 mg/kg should be set for that substance. Column 8 of Table 1 of Annex I to Regulation (EU) No 10/2011 incorrectly states that migration of the substance shall be non-detectable and should therefore be corrected.

| (5) | The SCF proposed to determine the residual content of the substance 1,4-butanediol formal (FCM No 344) in the material instead of verifying compliance against the SML, because no suitable method to determine the substance in a food or simulant was available. Suitable methods to determine the substance in a food or simulant are available now. Therefore, verifying compliance by determining the residual should be replaced by migration testing. 1,4-butanediol formal may hydrolyse in contact with foods or simulants to form 1,4-butanediol (FCM No 254) and formaldehyde (FCM No 98). Therefore the total specific migration limits set for these substances should not be exceeded. As a result 1,4-butanediol formal should be added to group restrictions 15 and 30. As hydrolysis occurs only in certain cases, rules which indicate when verification of compliance to these group restrictions is needed should be added to Table 3. |
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(5)

The SCF proposed to determine the residual content of the substance 1,4-butanediol formal (FCM No 344) in the material instead of verifying compliance against the SML, because no suitable method to determine the substance in a food or simulant was available. Suitable methods to determine the substance in a food or simulant are available now. Therefore, verifying compliance by determining the residual should be replaced by migration testing. 1,4-butanediol formal may hydrolyse in contact with foods or simulants to form 1,4-butanediol (FCM No 254) and formaldehyde (FCM No 98). Therefore the total specific migration limits set for these substances should not be exceeded. As a result 1,4-butanediol formal should be added to group restrictions 15 and 30. As hydrolysis occurs only in certain cases, rules which indicate when verification of compliance to these group restrictions is needed should be added to Table 3.

| (6) | The Authority adopted a favourable scientific opinion (6) on a possible extension of the use of starting substance 1,4:3,6-dianhydrosorbitol (FCM No 364) to the use as a co-monomer for the production of polyesters, if used at levels of up to 40 mol % of the diol component in combination with ethylene glycol and/or 1,4-bis(hydroxymethyl)cyclohexane, and if polyesters made using 1,4:3,6-dianhydrosorbitol together with 1,4-bis(hydroxymethyl)cyclohexane are not used in contact with foods containing more than 15 % alcohol. The extension of the use of the substance to the new specifications does not endanger human health if those conditions are met. Therefore, the authorisation of FCM substance No 364 should be amended to include the additional specifications. |
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(6)

The Authority adopted a favourable scientific opinion (6) on a possible extension of the use of starting substance 1,4:3,6-dianhydrosorbitol (FCM No 364) to the use as a co-monomer for the production of polyesters, if used at levels of up to 40 mol % of the diol component in combination with ethylene glycol and/or 1,4-bis(hydroxymethyl)cyclohexane, and if polyesters made using 1,4:3,6-dianhydrosorbitol together with 1,4-bis(hydroxymethyl)cyclohexane are not used in contact with foods containing more than 15 % alcohol. The extension of the use of the substance to the new specifications does not endanger human health if those conditions are met. Therefore, the authorisation of FCM substance No 364 should be amended to include the additional specifications.

| (7) | The Authority adopted a favourable scientific opinion (7) on a possible extension of the use of the substance kaolin (FCM No 410) to include particles in the nanoform with a thickness less than 100 nm and incorporated up to 12 % in ethylene vinyl alcohol (EVOH) copolymer. The extension of the use of the substance to the new specification does not endanger human health if those conditions are met. Therefore, the authorisation of FCM substance No 410 should be amended to include a specification and restriction on particle size. |
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(7)

The Authority adopted a favourable scientific opinion (7) on a possible extension of the use of the substance kaolin (FCM No 410) to include particles in the nanoform with a thickness less than 100 nm and incorporated up to 12 % in ethylene vinyl alcohol (EVOH) copolymer. The extension of the use of the substance to the new specification does not endanger human health if those conditions are met. Therefore, the authorisation of FCM substance No 410 should be amended to include a specification and restriction on particle size.

| (8) | The Union list includes a substance identified as ‘charcoal, activated’ (FCM No 713, CAS No 64365-11-3). Another substance is also used on the market, identified as ‘activated carbon’ (CAS No 7440-44-0). In practice the two substances are the same, and their names are used interchangeably and are synonymous. Therefore, it should be made clear that FCM substance No 713 covers the substance under the name ‘charcoal, activated’ and applies to both CAS numbers. The authorisation of FCM substance No 713 should therefore be amended by adding the CAS No for activated carbon. |
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(8)

The Union list includes a substance identified as ‘charcoal, activated’ (FCM No 713, CAS No 64365-11-3). Another substance is also used on the market, identified as ‘activated carbon’ (CAS No 7440-44-0). In practice the two substances are the same, and their names are used interchangeably and are synonymous. Therefore, it should be made clear that FCM substance No 713 covers the substance under the name ‘charcoal, activated’ and applies to both CAS numbers. The authorisation of FCM substance No 713 should therefore be amended by adding the CAS No for activated carbon.

| (9) | On the basis of new toxicological data the Authority adopted a favourable scientific opinion (8) which allows increasing the migration limit for the additive 1,3,5-tris(2,2-dimethylpropanamido)benzene (FCM No 784). to 5 mg/kg food. Therefore, the authorisation of substance FCM No 784 should be amended accordingly. |
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(9)

On the basis of new toxicological data the Authority adopted a favourable scientific opinion (8) which allows increasing the migration limit for the additive 1,3,5-tris(2,2-dimethylpropanamido)benzene (FCM No 784). to 5 mg/kg food. Therefore, the authorisation of substance FCM No 784 should be amended accordingly.

| (10) | The restriction which is defined for polyethyleneglycol (EO = 1-50) ethers of linear and branched primary (C8-C22) alcohols (FCM No 799) refers to the purity criteria for ethylene oxide laid down in Commission Directive 2008/84/EC (9). That Directive has been repealed by Commission Regulation (EU) No 231/2012 (10) which specifies the purity criteria for certain food additives setting out a maximum ethylene oxide content for those additives. That maximum should also apply to substances with FCM No 799. |
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(10)

The restriction which is defined for polyethyleneglycol (EO = 1-50) ethers of linear and branched primary (C8-C22) alcohols (FCM No 799) refers to the purity criteria for ethylene oxide laid down in Commission Directive 2008/84/EC (9). That Directive has been repealed by Commission Regulation (EU) No 231/2012 (10) which specifies the purity criteria for certain food additives setting out a maximum ethylene oxide content for those additives. That maximum should also apply to substances with FCM No 799.

| (11) | The group of substances ‘acids, fatty (C8-C22), esters with pentaerythritol’ (FCM No 880) is listed in Table 1 of Annex I to Regulation (EU) No 10/2011 with CAS No 85116-93-4. This CAS number refers only to a subgroup of FCM No 880, and is therefore inappropriate. For the group with FCM No 880 no CAS number is defined. Therefore, the listing of FCM substance No 880 in Table 1 of Annex I should be amended by deleting the CAS number. |
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(11)

The group of substances ‘acids, fatty (C8-C22), esters with pentaerythritol’ (FCM No 880) is listed in Table 1 of Annex I to Regulation (EU) No 10/2011 with CAS No 85116-93-4. This CAS number refers only to a subgroup of FCM No 880, and is therefore inappropriate. For the group with FCM No 880 no CAS number is defined. Therefore, the listing of FCM substance No 880 in Table 1 of Annex I should be amended by deleting the CAS number.

| (12) | The Authority adopted a favourable scientific opinion (11) on the possible extension of the use of the substance 2,2,4,4-tetramethylcyclobutane-1,3-diol (FCM No 881) to single use applications. The opinion concluded that for single use applications, the substance does not raise a safety concern if used as co-monomer in the production of polyesters at use levels up to 35 mol % of the diol component, in contact with all food types other than spirits and highly fatty foods to be simulated by food simulant D2 (vegetable oil) for long time storage at room temperature or below and hot fill. In its evaluation the authority only considered migration tests with 10 % ethanol and 3 % acetic acid as basis for full evaluation. Therefore, the extension of use should also not include foods with an alcohol content over 10 %. Therefore, if the permitted use of this substance is extended accordingly and includes the new specifications, the use of this substance does not endanger human health. Therefore, the authorisation of FCM substance No 881 should be amended accordingly. |
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(12)

The Authority adopted a favourable scientific opinion (11) on the possible extension of the use of the substance 2,2,4,4-tetramethylcyclobutane-1,3-diol (FCM No 881) to single use applications. The opinion concluded that for single use applications, the substance does not raise a safety concern if used as co-monomer in the production of polyesters at use levels up to 35 mol % of the diol component, in contact with all food types other than spirits and highly fatty foods to be simulated by food simulant D2 (vegetable oil) for long time storage at room temperature or below and hot fill. In its evaluation the authority only considered migration tests with 10 % ethanol and 3 % acetic acid as basis for full evaluation. Therefore, the extension of use should also not include foods with an alcohol content over 10 %. Therefore, if the permitted use of this substance is extended accordingly and includes the new specifications, the use of this substance does not endanger human health. Therefore, the authorisation of FCM substance No 881 should be amended accordingly.

| (13) | The Authority adopted a scientific opinion (12) on the use of three new substances in nanoform, (butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer cross-linked with divinylbenzene (FCM No 859), (butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer not cross-linked (FCM No 998) and (butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer cross-linked with 1,3-butanediol dimethacrylate (FCM No 1043). The Authority has no safety concern in case those substances are used at a maximum combined weight percentage of 10 % w/w in non-plasticised polyvinyl chloride in contact with all food types at ambient temperature or below, including long-term storage, and when used individually or in combination as additives, and when the diameter of the particles is larger than 20 nm, and for at least 95 % by number the diameter is larger than 40 nm. Therefore, the use of those substances does not endanger human health when used in accordance with those specifications, and these substances should be inserted accordingly in Table 1 of Annex I to Regulation (EU) No 10/2011. |
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(13)

The Authority adopted a scientific opinion (12) on the use of three new substances in nanoform, (butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer cross-linked with divinylbenzene (FCM No 859), (butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer not cross-linked (FCM No 998) and (butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer cross-linked with 1,3-butanediol dimethacrylate (FCM No 1043). The Authority has no safety concern in case those substances are used at a maximum combined weight percentage of 10 % w/w in non-plasticised polyvinyl chloride in contact with all food types at ambient temperature or below, including long-term storage, and when used individually or in combination as additives, and when the diameter of the particles is larger than 20 nm, and for at least 95 % by number the diameter is larger than 40 nm. Therefore, the use of those substances does not endanger human health when used in accordance with those specifications, and these substances should be inserted accordingly in Table 1 of Annex I to Regulation (EU) No 10/2011.

| (14) | The Authority adopted a favourable scientific opinion (13) on the use of the new polymer production aid 2H-perfluoro-[(5,8,11,14-tetramethyl)-tetraethyleneglycol ethyl propyl ether] (FCM No 903). That substance should only be used as a polymer production aid in the polymerisation process of fluoropolymers. During that process the sintering or processing conditions set out in the opinion should be applied. The use of this substance does not endanger human health when used in accordance with those specifications and it should be added to Table 1 of Annex I to Regulation (EU) No 10/2011. |
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(14)

The Authority adopted a favourable scientific opinion (13) on the use of the new polymer production aid 2H-perfluoro-[(5,8,11,14-tetramethyl)-tetraethyleneglycol ethyl propyl ether] (FCM No 903). That substance should only be used as a polymer production aid in the polymerisation process of fluoropolymers. During that process the sintering or processing conditions set out in the opinion should be applied. The use of this substance does not endanger human health when used in accordance with those specifications and it should be added to Table 1 of Annex I to Regulation (EU) No 10/2011.

| (15) | The Authority adopted a favourable scientific opinion (14) on the use of the new additive ethylene-vinyl acetate copolymer wax (FCM No 969), provided that the substance is used as an additive up to 2 % w/w in only polyolefin materials and articles and the migration of low molecular weight oligomeric fraction below 1 000 Da does not exceed 5 mg/kg food. The use of this substance does not endanger human health when used in accordance with those specifications and it should be added to Table 1 of Annex I to Regulation (EU) No 10/2011. |
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(15)

The Authority adopted a favourable scientific opinion (14) on the use of the new additive ethylene-vinyl acetate copolymer wax (FCM No 969), provided that the substance is used as an additive up to 2 % w/w in only polyolefin materials and articles and the migration of low molecular weight oligomeric fraction below 1 000 Da does not exceed 5 mg/kg food. The use of this substance does not endanger human health when used in accordance with those specifications and it should be added to Table 1 of Annex I to Regulation (EU) No 10/2011.

| (16) | The Authority adopted a favourable scientific opinion (15) on the use of the new additive polyglycerol (FCM No 1017). The opinion concluded that the substance does not raise a safety concern if it is used as plasticiser at a maximum use level of 6,5 % w/w in polymer blends of aliphatic-aromatic polyesters. As the opinion states that the substance is a naturally occurring hydrolysis product of an authorised food additive (E475) with authorised use levels up to 10 g/kg food, it can be concluded that the substance would be of no safety concern when migration is above the generic specific migration limit referred to Article 11(2) of Regulation (EU) No 10/2011. The Authority reached its conclusion also on the basis that the substance would not decompose during its processing in plastic material. Therefore, the use of the substance would not endanger human health if the generic specific migration limit is respected and decomposition of the substance during processing is avoided. Therefore, this additive should be added to Table 1 of Annex I to Regulation (EU) No 10/2011, with an additional specification preventing its decomposition during processing. |
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(16)

The Authority adopted a favourable scientific opinion (15) on the use of the new additive polyglycerol (FCM No 1017). The opinion concluded that the substance does not raise a safety concern if it is used as plasticiser at a maximum use level of 6,5 % w/w in polymer blends of aliphatic-aromatic polyesters. As the opinion states that the substance is a naturally occurring hydrolysis product of an authorised food additive (E475) with authorised use levels up to 10 g/kg food, it can be concluded that the substance would be of no safety concern when migration is above the generic specific migration limit referred to Article 11(2) of Regulation (EU) No 10/2011. The Authority reached its conclusion also on the basis that the substance would not decompose during its processing in plastic material. Therefore, the use of the substance would not endanger human health if the generic specific migration limit is respected and decomposition of the substance during processing is avoided. Therefore, this additive should be added to Table 1 of Annex I to Regulation (EU) No 10/2011, with an additional specification preventing its decomposition during processing.

| (17) | The mixture ‘polyethyleneglycol (EO = 2-6) monoalkyl (C16-C18) ether’ (FCM No 725) is a subgroup of the mixture, ‘polyethyleneglycol (EO = 1-50) ethers of linear and branched primary (C8-C22) alcohols’ (FCM No 799.) The SML and other restrictions for FCM No 799 are based on a more recent scientific evaluation (16). The entry for FCM No 725 is covered by the entry for FCM No 799 and should therefore be removed from Table 1 of Annex I to Regulation (EU) No 10/2011. |
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(17)

The mixture ‘polyethyleneglycol (EO = 2-6) monoalkyl (C16-C18) ether’ (FCM No 725) is a subgroup of the mixture, ‘polyethyleneglycol (EO = 1-50) ethers of linear and branched primary (C8-C22) alcohols’ (FCM No 799.) The SML and other restrictions for FCM No 799 are based on a more recent scientific evaluation (16). The entry for FCM No 725 is covered by the entry for FCM No 799 and should therefore be removed from Table 1 of Annex I to Regulation (EU) No 10/2011.

| (18) | To limit the administrative burden to business operators, plastic materials and articles which have been lawfully placed on the market based on the requirements set out in Regulation (EU) No 10/2011 before the entry into force of this Regulation and which do not comply with this Regulation should be able to be placed on the market until 26 February 2016. They should be able to remain on the market until exhaustion of stocks. |
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(18)

To limit the administrative burden to business operators, plastic materials and articles which have been lawfully placed on the market based on the requirements set out in Regulation (EU) No 10/2011 before the entry into force of this Regulation and which do not comply with this Regulation should be able to be placed on the market until 26 February 2016. They should be able to remain on the market until exhaustion of stocks.

| (19) | Regulation (EU) No 10/2011 should therefore be amended accordingly. |
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(19)

Regulation (EU) No 10/2011 should therefore be amended accordingly.

| (20) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
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(20)

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 I to Regulation (EU) No 10/2011 is amended in accordance with the Annex to this Regulation.

Article 2

Plastic materials and articles complying with the requirements of Regulation (EU) No 10/2011 as applicable before 26 February 2015 may be placed on the market until 26 February 2016. Those plastic materials and articles may remain on the market after that date until exhaustion of stocks.

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.

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

Done at Brussels, 5 February 2015.

For the Commission

The President

Jean-Claude JUNCKER

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(1)  OJ L 338, 13.11.2004, p. 4.

1

(2)  Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food (OJ L 12, 15.1.2011, p. 1).

2

(3)  Report of the Scientific Committee for foods, 25th series, EUR 13416, 1991.

3

th

(4)  EFSA Journal 2013; 11(4):3189.

4

(5)  Opinion of the Scientific Committee on Food on the 11th additional list of monomers and additives for food contact materials, SCF/CS/PM/GEN/M8313, November 2000.

5

(6)  EFSA Journal 2013; 11(6):3244.

6

(7)  EFSA Journal 2014; 12(4):3637.

7

(8)  EFSA Journal 2013; 11(7):3306.

8

(9)  Commission Directive 2008/84/EC of 27 August 2008 laying down specific purity criteria on food additives other than colours and sweeteners (OJ L 253, 20.9.2008, p. 1).

9

(10)  Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (OJ L 83, 22.3.2012, p. 1).

10

(11)  EFSA Journal 2013; 11(10):3388.

11

(12)  EFSA Journal 2014; 12(4):3635.

12

(13)  EFSA Journal 2012; 10(12):2978.

13

(14)  EFSA Journal 2014; 12(2):3555.

14

(15)  EFSA Journal 2013; 11(10):3389.

15

(16)  FCM 725 was evaluated by the SCF, http://europa.eu.int/comm/food/fs/sc/scf/out20_en.pdf. FCM 799 was evaluated by EFSA, EFSA Journal (2008) 698-699.

16

---

ANNEX

Annex I to Regulation (EU) No 10/2011 is amended as follows:

| (1) | Table 1 is amended as follows:






  (a) | the entries concerning FCM substances Nos 161, 241, 344, 364, 410, 713, 784, 799, 880 and 881 are replaced by the following:















  ‘161 | 92160 | 000087-69-4 | L-(+)-tartaric acid | yes | no | no | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 241 | 22960 | 0000108-95-2 | phenol | no | yes | no | 3 | | | |
| 344 | 13810 | 0000505-65-7 | 1,4-butanediol formal | no | yes | no | 0,05 | 15
  30 | | (21) |
| 21821 |
| 364 | 15404 | 0000652-67-5 | 1,4:3,6-dianhydrosorbitol | no | yes | no | 5 | | Only to be used as:






  (a) | a co-monomer in poly(ethylene-co-isosorbide terephthalate); |

(1)

Table 1 is amended as follows:

(a)

the entries concerning FCM substances Nos 161, 241, 344, 364, 410, 713, 784, 799, 880 and 881 are replaced by the following:

‘161

92160

000087-69-4

L-(+)-tartaric acid

yes

no

no

241

22960

0000108-95-2

phenol

no

yes

no

3

344

13810

0000505-65-7

1,4-butanediol formal

no

yes

no

0,05

15

30

(21)

21821

364

15404

0000652-67-5

1,4:3,6-dianhydrosorbitol

no

yes

no

5

Only to be used as:

(a)

a co-monomer in poly(ethylene-co-isosorbide terephthalate);

| (b) | a co-monomer at levels of up to 40 mole % of the diol component in combination with ethylene glycol and/or 1,4-bis(hydroxymethyl)cyclohexane, for the production of polyesters. |
| --- | --- |

(b)

a co-monomer at levels of up to 40 mole % of the diol component in combination with ethylene glycol and/or 1,4-bis(hydroxymethyl)cyclohexane, for the production of polyesters.

Polyesters made using dianhydrosorbitol together with 1,4-bis(hydroxymethyl)cyclohexane shall not be used in contact with foods containing more than 15 % alcohol.

410

62720

0001332-58-7

kaolin

yes

no

no

Particles can be thinner than 100 nm only if incorporated at a quantity of less than 12 % w/w in an ethylene vinyl alcohol copolymer (EVOH) inner layer of a multi-layer structure, in which the layer in direct contact with the food provides a functional barrier preventing migration of particles into the food.

713

43480

0064365-11-3

charcoal, activated

yes

no

no

Only for use in PET at maximum 10 mg/kg of polymer.

Same purity requirements as for Vegetable Carbon (E 153) set out by Commission Regulation (EU) No 231/2012 (1) with exception of ash content which can be up to 10 % (w/w).

0007440-44-0

784

95420

0745070-61-5

1,3,5-tris (2,2-di-methylpropanamido) benzene

yes

no

no

5

799

77708

polyethyleneglycol (EO = 1-50) ethers of linear and branched primary (C8-C22) alcohols

yes

no

no

1,8

In compliance with the maximum ethylene oxide content as laid down in the purity criteria for food additives in Commission Regulation (EU) No 231/2012.

880

31348

acids, fatty (C8-C22), esters with pentaerythritol'

yes

no

no

881

25187

0003010-96-6

2,2,4,4-tetramethylcyclobutane-1,3-diol

no

yes

no

5

Only for:

| (a) | repeated use articles for long term storage at room temperature or below and hotfill; |
| --- | --- |

(a)

repeated use articles for long term storage at room temperature or below and hotfill;

| (b) | single use materials and articles as a co-monomer at a maximum use level of 35 mole % of the diol component of polyesters, and if such materials and articles are for long term storage at room temperature or below of food types which have an alcohol content of up to 10 % and for which Table 2 of Annex III does not assign simulant D2. Hot fill conditions are allowed for such single use materials and articles. |
| --- | --- |

(b)

single use materials and articles as a co-monomer at a maximum use level of 35 mole % of the diol component of polyesters, and if such materials and articles are for long term storage at room temperature or below of food types which have an alcohol content of up to 10 % and for which Table 2 of Annex III does not assign simulant D2. Hot fill conditions are allowed for such single use materials and articles.

| (b) | the following entries are inserted in numerical order of the FCM substance numbers:















  ‘859 | | | (butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer crosslinked with divinylbenzene, in nanoform | yes | no | no | | | Only to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long-term storage.
  When used together with the substance with FCM No 998 and/or the substance with FCM No 1043, the restriction of 10 % w/w applies to the sum of those substances.
  The diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm. | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 903 | | 37486-69-4 | 2H-perfluoro-[(5,8,11,14-tetramethyl)-tetraethyleneglycol ethyl propyl ether] | yes | no | no | | | Only to be used as a polymer production aid in the polymerisation of fluoropolymers intended for:






  (a) | repeated and single use materials and articles when sintered or processed (non-sintered) at temperatures at or above 360 °C for at least 10 minutes or at higher temperatures for equivalent shorter times; |

(b)

the following entries are inserted in numerical order of the FCM substance numbers:

‘859

(butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer crosslinked with divinylbenzene, in nanoform

yes

no

no

Only to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long-term storage.

When used together with the substance with FCM No 998 and/or the substance with FCM No 1043, the restriction of 10 % w/w applies to the sum of those substances.

The diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm.

903

37486-69-4

2H-perfluoro-[(5,8,11,14-tetramethyl)-tetraethyleneglycol ethyl propyl ether]

yes

no

no

Only to be used as a polymer production aid in the polymerisation of fluoropolymers intended for:

(a)

repeated and single use materials and articles when sintered or processed (non-sintered) at temperatures at or above 360 °C for at least 10 minutes or at higher temperatures for equivalent shorter times;

| (b) | repeated use materials and articles when processed (non-sintered) at temperatures from 300 °C and up to 360 °C for at least 10 minutes. |
| --- | --- |

(b)

repeated use materials and articles when processed (non-sintered) at temperatures from 300 °C and up to 360 °C for at least 10 minutes.

969

24937-78-8

ethylene-vinyl acetate copolymer wax

yes

no

no

Only to be used as a polymeric additive up to 2 % w/w in polyolefins.

The migration of low molecular weight oligomeric fraction below 1 000 Da shall not exceed 5 mg/kg food.

998

(butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer not cross-linked, in nanoform

yes

no

no

Only to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long-term storage.

When used together with the substance with FCM No 859 and/or the substance with FCM No 1043, the restriction of 10 % w/w applies to the sum of those substances.

The diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm.

1017

25618-55-7

polyglycerol

yes

no

no

To be processed under conditions preventing the decomposition of the substance and up to a maximum temperature of 275 °C.

1043

(butadiene, ethyl acrylate, methyl methacrylate, styrene) copolymer crosslinked with 1,3-butanediol dimethacrylate, in nanoform

yes

no

no

Only to be used as particles in non-plasticised PVC up to 10 % w/w in contact with all food types at room temperature or below including long-term storage.

When used together with the substance with FCM No 859 and/or the substance with FCM No 998, the restriction of 10 % w/w applies to the sum of those substances.

The diameter of particles shall be > 20 nm, and for at least 95 % by number it shall be > 40 nm.’

| (c) | The entry concerning FCM substance No 725 is deleted. |
| --- | --- |

(c)

The entry concerning FCM substance No 725 is deleted.

| (2) | In Table 2, the entries concerning group restrictions Nos 15 and 30 are replaced by the following:








  ‘15 | 98
  196
  344 | 15 | expressed as formaldehyde |
| --- | --- | --- | --- | --- |
| 30 | 254
  344
  672 | 5 | expressed as 1,4-butanediol’ |

(2)

In Table 2, the entries concerning group restrictions Nos 15 and 30 are replaced by the following:

‘15

98

196

344

15

expressed as formaldehyde

30

254

344

672

5

expressed as 1,4-butanediol’

| (3) | In Table 3, the following entry is added:






  ‘(21) | In case of reaction with foods or simulants verification of compliance shall include verification that the migration limits of the hydrolysis products, formaldehyde and 1,4-butanediol, are not exceeded.’ |
| --- | --- | --- |

(3)

In Table 3, the following entry is added:

‘(21)

In case of reaction with foods or simulants verification of compliance shall include verification that the migration limits of the hydrolysis products, formaldehyde and 1,4-butanediol, are not exceeded.’

---

(1)  Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications of food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (OJ L 83, 22.3.2012, p. 1).’

---

| 6.2.2015 | EN | Official Journal of the European Union | L 30/10 |
| --- | --- | --- | --- |

6.2.2015

EN

Official Journal of the European Union

L 30/10

---

COMMISSION IMPLEMENTING REGULATION (EU) 2015/175

of 5 February 2015

laying down special conditions applicable to the import of guar gum originating in or consigned from India due to contamination risks by pentachlorophenol and dioxins

(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 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 (1), and in particular Article 53(1)(b)(ii) thereof,

Whereas:

| (1) | Article 53(1) of Regulation (EC) No 178/2002 provides for the possibility to adopt appropriate Union emergency measures for feed and food imported from a third country in order to protect human health, animal health and the environment, where the risk cannot be contained satisfactorily by means of measures taken by the Member States individually. |
| --- | --- |

(1)

Article 53(1) of Regulation (EC) No 178/2002 provides for the possibility to adopt appropriate Union emergency measures for feed and food imported from a third country in order to protect human health, animal health and the environment, where the risk cannot be contained satisfactorily by means of measures taken by the Member States individually.

| (2) | In July 2007, high levels of pentachlorophenol (PCP) and dioxins have been found in the Union in certain batches of guar gum originating in or consigned from India. Such contamination constitutes a threat to public health within the Union if no measures are taken to avoid the presence of pentachlorophenol and dioxins in guar gum. |
| --- | --- |

(2)

In July 2007, high levels of pentachlorophenol (PCP) and dioxins have been found in the Union in certain batches of guar gum originating in or consigned from India. Such contamination constitutes a threat to public health within the Union if no measures are taken to avoid the presence of pentachlorophenol and dioxins in guar gum.

| (3) | Therefore special conditions on the imports of guar gum originating in or consigned from India were established by Commission Decision 2008/352/EC (2), later replaced by Commission Regulation (EU) No 258/2010 (3), due to contamination risks by pentachlorophenol and dioxins. |
| --- | --- |

(3)

Therefore special conditions on the imports of guar gum originating in or consigned from India were established by Commission Decision 2008/352/EC (2), later replaced by Commission Regulation (EU) No 258/2010 (3), due to contamination risks by pentachlorophenol and dioxins.

| (4) | As follow-up to the audits of the Food and Veterinary Office of the European Commission (FVO) in 2007 and 2009, another audit took place in October 2011 in order to assess the systems in place to control PCP and dioxin contamination in guar gum originating in or consigned from India and intended for export to the Union. |
| --- | --- |

(4)

As follow-up to the audits of the Food and Veterinary Office of the European Commission (FVO) in 2007 and 2009, another audit took place in October 2011 in order to assess the systems in place to control PCP and dioxin contamination in guar gum originating in or consigned from India and intended for export to the Union.

| (5) | During the audit of October 2011 the FVO observed that the competent authority of India has put in place a procedure to ensure that sampling is undertaken by one of two designated sampling bodies, in line with Union sampling provisions provided for in Commission Directive 2002/63/EC (4) and that all exported lots are accompanied by a certificate and by an analytical report from a laboratory accredited in accordance with EN ISO/IEC 17025 for the analysis of PCP in feed and food. The FVO noted that due to that procedure contaminated lots are not exported to the Union. |
| --- | --- |

(5)

During the audit of October 2011 the FVO observed that the competent authority of India has put in place a procedure to ensure that sampling is undertaken by one of two designated sampling bodies, in line with Union sampling provisions provided for in Commission Directive 2002/63/EC (4) and that all exported lots are accompanied by a certificate and by an analytical report from a laboratory accredited in accordance with EN ISO/IEC 17025 for the analysis of PCP in feed and food. The FVO noted that due to that procedure contaminated lots are not exported to the Union.

| (6) | The European Union Reference Laboratory for Dioxins and PCBs in Feed and Food has carried out a study on the correlation between PCP and dioxins in contaminated guar gum from India. From this study it can be concluded that guar gum containing a level of PCP below the Maximum Residue Limit (MRL) of 0,01 mg/kg does not contain unacceptable levels of dioxins. Therefore compliance with the MRL on PCP, ensures in this specific case also a high level of human health protection as regards dioxins |
| --- | --- |

(6)

The European Union Reference Laboratory for Dioxins and PCBs in Feed and Food has carried out a study on the correlation between PCP and dioxins in contaminated guar gum from India. From this study it can be concluded that guar gum containing a level of PCP below the Maximum Residue Limit (MRL) of 0,01 mg/kg does not contain unacceptable levels of dioxins. Therefore compliance with the MRL on PCP, ensures in this specific case also a high level of human health protection as regards dioxins

| (7) | The laboratory is still finding high levels of PCP in guar gum powder for export for use in food. As the legal status of PCP for industrial use remains unclear in India and as there is no evidence of the source of contamination, and no investigations on the source of contamination of non-compliant lots are undertaken, the potential for contaminated lots remains. |
| --- | --- |

(7)

The laboratory is still finding high levels of PCP in guar gum powder for export for use in food. As the legal status of PCP for industrial use remains unclear in India and as there is no evidence of the source of contamination, and no investigations on the source of contamination of non-compliant lots are undertaken, the potential for contaminated lots remains.

| (8) | Those findings indicate that the contamination of guar gum with PCP cannot be regarded as an isolated incident and that only the effective analysis by the approved laboratory has prevented contaminated product from being further exported to the Union. |
| --- | --- |

(8)

Those findings indicate that the contamination of guar gum with PCP cannot be regarded as an isolated incident and that only the effective analysis by the approved laboratory has prevented contaminated product from being further exported to the Union.

| (9) | As the source of contamination is not yet eliminated it is appropriate to maintain special conditions for import. However, it is appropriate to bring the control measures at import in line with existing control measures at import applicable to certain food and feed of non-animal origin. Given that such alignment entails several changes, it is appropriate to repeal Regulation (EU) No 258/2010 and replace it by a new Implementing Regulation. |
| --- | --- |

(9)

As the source of contamination is not yet eliminated it is appropriate to maintain special conditions for import. However, it is appropriate to bring the control measures at import in line with existing control measures at import applicable to certain food and feed of non-animal origin. Given that such alignment entails several changes, it is appropriate to repeal Regulation (EU) No 258/2010 and replace it by a new Implementing Regulation.

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

(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

Scope

1.   This Regulation shall apply to consignments of guar gum falling within CN code ex 1302 32 90, TARIC subdivision 10 and 19, originating in or consigned from India and intended for animal or human consumption.

2.   This Regulation shall also apply to consignments of compound feed and food containing guar gum referred to in paragraph 1 in a quantity above 20 %.

3.   This Regulation shall not apply to consignments referred to in paragraphs 1 and 2 which are destined to a private person for personal consumption and use only. In case of doubt on the destination of the consignment, the burden of proof lies with the recipient of the consignment.

4.   This Regulation shall be without prejudice to the provisions of Council Regulation (EEC) No 2913/92 (5).

Article 2

Definitions

For the purposes of this Regulation, the definitions laid down in Articles 2 and 3 of Regulation (EC) No 178/2002, Article 2 of Regulation (EC) No 882/2004 of the European Parliament and of the Council (6) and Article 3 of Commission Regulation (EC) No 669/2009 (7) shall apply.

For the purpose of this Regulation, a consignment corresponds to a lot as referred to in Commission Directive 2002/63/EC.

Article 3

Import into the Union

1.   Consignments referred to in Article 1(1) and (2) may only be imported into the Union in accordance with the procedures laid down in this Regulation.

2.   Consignments referred to in Article 1(1) and (2) may only enter the Union through a Designated Point of Entry (DPE) as defined in Regulation (EC) No 669/2009.

Article 4

Analytical report

1.   Consignments referred to in Article 1(1) and (2) shall be accompanied by an analytical report issued by a laboratory accredited in accordance with EN ISO/IEC 17025 for the analysis of PCP in feed and food, demonstrating that the product imported does not contain more than 0,01 mg/kg pentachlorophenol (PCP).

2.   The analytical report shall indicate:

| (a) | the results of sampling and analysis for the presence of PCP, performed by the competent authorities of the country of origin, or of the country where the consignment is consigned from if that country is different from the country of origin; |
| --- | --- |

(a)

the results of sampling and analysis for the presence of PCP, performed by the competent authorities of the country of origin, or of the country where the consignment is consigned from if that country is different from the country of origin;

| (b) | the measurement uncertainty of the analytical result; |
| --- | --- |

(b)

the measurement uncertainty of the analytical result;

| (c) | the limit of detection (LOD) of the analytical method; and |
| --- | --- |

(c)

the limit of detection (LOD) of the analytical method; and

| (d) | the limit of quantification (LOQ) of the analytical method. |
| --- | --- |

(d)

the limit of quantification (LOQ) of the analytical method.

3.   The sampling referred to in paragraph 2 shall be performed in accordance with Directive 2002/63/EC.

4.   The extraction before analysis shall be performed with an acidified solvent. The analysis shall be carried out according to the modified version of the Quechers method as set out on the website of the European Union Reference Laboratories for Residues of Pesticides (8) or according to an equally reliable method.

Article 5

Health certificate

1.   The consignments referred to in Article 1(1) and (2) shall be accompanied by a health certificate corresponding to the model set out in the Annex.

2.   The health certificate shall be completed, signed and verified by an authorised representative of the competent authority of the country of origin, the Ministry of Commerce and Industry of India, or of the country where the consignment is consigned from if that country is different from the country of origin.

3.   The health certificate shall be drawn up in one of the official languages of the Member State where the designated point of entry is located. However, a Member State may consent that health certificates be drawn up in another official language of the Union.

4.   The health certificate shall be valid for four months from the date of its issue.

Article 6

Identification

Each consignment referred to in Article 1(1) and (2) shall be identified with an identification code. That code shall be identical to the identification code appearing on the analytical report referred to in Article 4 and on the health certificate referred to in Article 5.

Each individual bag or package of the consignment shall be identified with that identification code.

Article 7

Prior notification of consignments

1.   Feed and food business operators shall give prior notification to the competent authorities at the DPE of:

| (a) | the estimated date and time of physical arrival of the consignment; and |
| --- | --- |

(a)

the estimated date and time of physical arrival of the consignment; and

| (b) | the nature of the consignment. |
| --- | --- |

(b)

the nature of the consignment.

2.   For the purpose of prior notification, feed and food business operators shall complete Part I of the common entry document (CED) provided for in Regulation (EC) No 669/2009. They shall transmit that document to the competent authority at the DPE at least one working day prior to the arrival of the consignment.

3.   For the completion of the CED, feed and food business operators shall take into account the notes for guidance for the CED laid down in Annex II to Regulation (EC) No 669/2009.

Article 8

Official controls

1.   The competent authority at the DPE shall carry out documentary checks of each consignment referred to in Article 1(1) and (2) to ensure compliance with the requirements laid down in Articles 4 and 5.

2.   The identity and physical checks of consignments referred to in Article 1(1) and (2) of this Regulation shall be carried out in accordance with Articles 8, 9 and 19 of Regulation (EC) No 669/2009 at a frequency of 5 %.

3.   After completion of the checks, the competent authorities shall:

| (a) | complete the relevant entries in Part II of the CED; |
| --- | --- |

(a)

complete the relevant entries in Part II of the CED;

| (b) | attach the results of the checks carried out in accordance with paragraph 2 of this Article; |
| --- | --- |

(b)

attach the results of the checks carried out in accordance with paragraph 2 of this Article;

| (c) | provide and fill the CED reference number on the CED; |
| --- | --- |

(c)

provide and fill the CED reference number on the CED;

| (d) | stamp and sign the original of the CED; |
| --- | --- |

(d)

stamp and sign the original of the CED;

| (e) | make and retain a copy of the signed and stamped CED. |
| --- | --- |

(e)

make and retain a copy of the signed and stamped CED.

4.   The original of the CED, of the health certificate referred to in Article 5 and of the analytical report referred to in Article 4 shall accompany the consignment during its transport until it is released into free circulation.

In case of authorisation of onward transportation of the consignment pending the results of the physical checks, as provided for in the third subparagraph of Article 8(2) of Regulation (EC) No 669/2009, an authenticated copy of the original CED shall accompany the consignment in place of the original.

Article 9

Splitting of a consignment

1.   Consignments shall not be split until all official controls have been completed, and the CED has been fully completed by the competent authorities as provided for in Article 8.

2.   In the case of subsequent splitting of the consignment, an authenticated copy of the CED shall accompany each part of the consignment during its transport until it is released for free circulation.

Article 10

Release into free circulation

1.   The release of consignments into free circulation shall be subject to the presentation by the feed or food business operator to the custom authorities of a CED duly completed by the competent authority once all official controls have been carried out. The CED may be presented physically or electronically.

2.   The custom authorities shall only release the consignment into free circulation if a favourable decision by the competent authority is indicated in box II.14 of the CED and box II.21 thereof is signed.

Article 11

Non-compliance

If the official controls establish non-compliance with the relevant Union legislation, the competent authority shall complete Part III of the CED and action shall be taken pursuant to Articles 19, 20 and 21 of Regulation (EC) No 882/2004.

Article 12

Reports

1.   Member States shall submit to the Commission every three months a report summarising the analytical reports of official controls of consignments referred to in Article 1(1) and (2) pursuant to this Regulation. That report shall be submitted during the month following each quarter.

2.   The report shall include the following information:

| (a) | the number of consignments imported; |
| --- | --- |

(a)

the number of consignments imported;

| (b) | the number of consignments subjected to sampling for analysis; |
| --- | --- |

(b)

the number of consignments subjected to sampling for analysis;

| (c) | the results of the checks as provided for in Article 8(2). |
| --- | --- |

(c)

the results of the checks as provided for in Article 8(2).

Article 13

Costs

All costs resulting from the official controls and any measures taken following non-compliance shall be borne by the feed and food business operators.

Article 14

Repeal

Regulation (EU) No 258/2010 is repealed.

Article 15

Transitional provisions

By way of derogation from Article 5(1), Member States shall authorise the imports of consignments referred to in Article 1(1) and (2) which left the country of origin before the date of entry into force of this Regulation accompanied by a health certificate as provided for by Regulation (EU) No 258/2010.

Article 16

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, 5 February 2015.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  OJ L 31, 1.2.2002, p. 1.

1

(2)  Commission Decision 2008/352/EC of 29 April 2008 imposing special conditions governing guar gum originating in or consigned from India due to contamination risks of those products by pentachlorophenol and dioxins (OJ L 117, 1.5.2008, p. 42).

2

(3)  Commission Regulation (EU) No 258/2010 of 25 March 2010 imposing special conditions on the imports of guar gum originating in or consigned from India due to contamination risks of those products by pentachlorophenol and dioxins and repealing Decision 2008/352/EC (OJ L 80, 26.3.2010, p. 28).

3

(4)  Commission Directive 2002/63/EC of 11 July 2002 establishing Community methods of sampling for the official control of pesticides residues in and on products of plant and animal origin and repealing Directive 79/700/EEC (OJ L 187, 16.7.2002, p. 30).

4

(5)  Council Regulation (EEC) No 2913/92 of 12 October 1992 establishing the Community Customs Code (OJ L 302, 19.10.1992, p. 1).

5

(6)  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).

6

(7)  Commission Regulation (EC) No 669/2009 of 24 July 2009 implementing Regulation (EC) No 882/2004 of the European Parliament and of the Council as regards the increased level of official controls on imports of certain feed and food of non-animal origin and amending Decision 2006/504/EC (OJ L 194, 25.7.2009, p. 11).

7

(8)  http://www.eurl-pesticides.eu/library/docs/srm/QuechersForGuarGum.pdf

8

---

ANNEX

Health Certificate for the importation into the European Union of

(1)

Consignment Code
  Certificate Number

According to the provisions of Commission Implementing Regulation (EU) 2015/175 laying down special conditions applicable to the import of guar gum originating in or consigned from India due to contamination risks by pentachlorophenol and dioxins, the

(competent authority referred to in Article 5(2) of Regulation (EU) 2015/175)

CERTIFIES that the

(insert feed or food referred to in Article 1 of Regulation (EU) 2015/175)

of this consignment composed of:

(description of consignment, product, number and type of packages, gross or net weight)

embarked at (embarkation place)

by (identification of transporter)

going to (place and country of destination)

which comes from the establishment

(name and address of establishment)

have been produced, sorted, handled, processed, packaged and transported in line with good hygiene practices.

From this consignment, samples were taken in accordance with Commission Directive 2002/63/EC on (date), subjected to laboratory analysis on

(date) in the

(name of laboratory). The details of sampling, methods of analysis used and all results are attached.

This certificate is valid until

Done at on

Stamp and signature of authorised representative of competent authority referred to in Article 5(2)

---

(1)  Product and country of origin.

---

| 6.2.2015 | EN | Official Journal of the European Union | L 30/16 |
| --- | --- | --- | --- |

6.2.2015

EN

Official Journal of the European Union

L 30/16

---

COMMISSION IMPLEMENTING REGULATION (EU) 2015/176

of 5 February 2015

Approving non-minor amendments to the specification for a name entered in the register of traditional specialities guaranteed [Prekmurska gibanica (TSG)]

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (1), and in particular Article 52(2) thereof,

Whereas:

| (1) | Pursuant to the first subparagraph of Article 53(1) of Regulation (EU) No 1151/2012, the Commission has examined Slovenia's application for the approval of amendments to the specification for the traditional speciality guaranteed ‘Prekmurska gibanica’, registered under Commission Regulation (EU) No 172/2010 (2). |
| --- | --- |

(1)

Pursuant to the first subparagraph of Article 53(1) of Regulation (EU) No 1151/2012, the Commission has examined Slovenia's application for the approval of amendments to the specification for the traditional speciality guaranteed ‘Prekmurska gibanica’, registered under Commission Regulation (EU) No 172/2010 (2).

| (2) | Since the amendments in question are not minor within the meaning of Article 53(2) of Regulation (EU) No 1151/2012, the Commission published the amendment application in the Official Journal of the European Union
   (3) as required by Article 50(2)(b) of that Regulation. |
| --- | --- |

(2)

Since the amendments in question are not minor within the meaning of Article 53(2) of Regulation (EU) No 1151/2012, the Commission published the amendment application in the Official Journal of the European Union
   (3) as required by Article 50(2)(b) of that Regulation.

| (3) | As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the amendments to the specification should be approved, |
| --- | --- |

(3)

As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the amendments to the specification should be approved,

HAS ADOPTED THIS REGULATION:

Article 1

The amendments to the specification published in the Official Journal of the European Union regarding the name ‘Prekmurska gibanica’ (TSG) are hereby approved.

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, 5 February 2015.

For the Commission

The President

Jean-Claude JUNCKER

---

(1)  OJ L 343, 14.12.2012, p. 1.

1

(2)  Commission Regulation (EU) No 172/2010 of 1 March 2010 entering a name in the register of traditional specialities guaranteed [Prekmurska gibanica (TSG)] (OJ L 51, 2.3.2010, p. 11).

2

(3)  OJ C 297, 4.9.2014, p. 15.

3

---

| 6.2.2015 | EN | Official Journal of the European Union | L 30/17 |
| --- | --- | --- | --- |

6.2.2015

EN

Official Journal of the European Union

L 30/17

---

COMMISSION IMPLEMENTING REGULATION (EU) 2015/177

of 5 February 2015

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. |
| --- | --- |

(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, |
| --- | --- |

(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, 5 February 2015.

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.

1

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

2

---

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 | EG | 344,2 |
| IL | 99,6 |
| MA | 83,5 |
| SN | 316,2 |
| TR | 120,0 |
| ZZ | 192,7 |
| 0707 00 05 | TR | 185,3 |
| ZZ | 185,3 |
| 0709 91 00 | EG | 60,6 |
| ZZ | 60,6 |
| 0709 93 10 | MA | 232,3 |
| TR | 245,7 |
| ZZ | 239,0 |
| 0805 10 20 | EG | 48,5 |
| IL | 75,2 |
| MA | 59,5 |
| TN | 53,4 |
| TR | 67,7 |
| ZZ | 60,9 |
| 0805 20 10 | IL | 144,7 |
| MA | 91,9 |
| ZZ | 118,3 |
| 0805 20 30, 0805 20 50, 0805 20 70, 0805 20 90 | CN | 56,6 |
| EG | 74,4 |
| IL | 122,4 |
| JM | 115,2 |
| MA | 133,9 |
| TR | 82,6 |
| ZZ | 97,5 |
| 0805 50 10 | TR | 58,9 |
| ZZ | 58,9 |
| 0808 10 80 | BR | 65,8 |
| CL | 90,1 |
| US | 193,9 |
| ZZ | 116,6 |
| 0808 30 90 | CL | 307,7 |
| CN | 93,4 |
| US | 130,9 |
| ZA | 100,9 |
| ZZ | 158,2 |

(EUR/100 kg)

CN code

Third country code (1)

Standard import value

0702 00 00

EG

344,2

IL

99,6

MA

83,5

SN

316,2

TR

120,0

ZZ

192,7

0707 00 05

TR

185,3

ZZ

185,3

0709 91 00

EG

60,6

ZZ

60,6

0709 93 10

MA

232,3

TR

245,7

ZZ

239,0

0805 10 20

EG

48,5

IL

75,2

MA

59,5

TN

53,4

TR

67,7

ZZ

60,9

0805 20 10

IL

144,7

MA

91,9

ZZ

118,3

0805 20 30, 0805 20 50, 0805 20 70, 0805 20 90

CN

56,6

EG

74,4

IL

122,4

JM

115,2

MA

133,9

TR

82,6

ZZ

97,5

0805 50 10

TR

58,9

ZZ

58,9

0808 10 80

BR

65,8

CL

90,1

US

193,9

ZZ

116,6

0808 30 90

CL

307,7

CN

93,4

US

130,9

ZA

100,9

ZZ

158,2

---

(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’.

---

DECISIONS

| 6.2.2015 | EN | Official Journal of the European Union | L 30/20 |
| --- | --- | --- | --- |

6.2.2015

EN

Official Journal of the European Union

L 30/20

---

COUNCIL DECISION (EU) 2015/178

of 27 January 2015

on the position to be taken on behalf of the European Union within the Sanitary and Phytosanitary Sub-Committee, the Customs Sub-Committee and the Geographical Indications Sub-Committee established by the Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and the Republic of Moldova, of the other part, as regards the adoption of decisions of the Sanitary and Phytosanitary Sub-Committee, the Customs Sub-Committee and the Geographical Indications Sub-Committee on their Rules of Procedure

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular the first subparagraph of Article 207(4) in conjunction with Article 218(9) thereof,

Having regard to the proposal from the European Commission,

Whereas:

| (1) | Article 464 of the Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and the Republic of Moldova, of the other part (1) (‘the Agreement’) provides for provisional application of the Agreement in part. |
| --- | --- |

(1)

Article 464 of the Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and the Republic of Moldova, of the other part (1) (‘the Agreement’) provides for provisional application of the Agreement in part.

| (2) | Article 3 of Council Decision 2014/492/EU (2) specifies which parts of the Agreement are to be applied provisionally, including the provisions on the establishment and functioning of the Sanitary and Phytosanitary Sub-Committee (‘SPS Sub-Committee’), the Customs Sub-Committee, and the Geographical Indications Sub-Committee (‘GI Sub-Committee’). |
| --- | --- |

(2)

Article 3 of Council Decision 2014/492/EU (2) specifies which parts of the Agreement are to be applied provisionally, including the provisions on the establishment and functioning of the Sanitary and Phytosanitary Sub-Committee (‘SPS Sub-Committee’), the Customs Sub-Committee, and the Geographical Indications Sub-Committee (‘GI Sub-Committee’).

| (3) | Pursuant to Article 191(5) of the Agreement, the SPS Sub-Committee is to adopt its own rules of procedure at its first meeting. |
| --- | --- |

(3)

Pursuant to Article 191(5) of the Agreement, the SPS Sub-Committee is to adopt its own rules of procedure at its first meeting.

| (4) | Pursuant to Article 200(3)(e) of the Agreement, the Customs Sub-Committee is to adopt its own rules of procedure. |
| --- | --- |

(4)

Pursuant to Article 200(3)(e) of the Agreement, the Customs Sub-Committee is to adopt its own rules of procedure.

| (5) | Pursuant to Article 306(3) of the Agreement, the GI Sub-Committee is to determine its own rules of procedure. |
| --- | --- |

(5)

Pursuant to Article 306(3) of the Agreement, the GI Sub-Committee is to determine its own rules of procedure.

| (6) | It is therefore appropriate to determine the Union position in relation to the rules of procedure to be adopted by those sub-committees, |
| --- | --- |

(6)

It is therefore appropriate to determine the Union position in relation to the rules of procedure to be adopted by those sub-committees,

HAS ADOPTED THIS DECISION:

Article 1

1.   The position to be taken on behalf of the Union within the Sanitary and Phytosanitary Sub-Committee established by Article 191 of the Agreement, as regards the adoption of the Rules of Procedure of the SPS Sub-Committee shall be based on the draft Decision of that sub-committee attached to this Decision.

2.   Minor technical corrections to the draft Decision may be agreed by the representatives of the Union in the SPS Sub-Committee without further decision of the Council.

Article 2

1.   The position to be taken on behalf of the Union within the Customs Sub-Committee established by Article 200 of the Agreement, as regards the adoption of the Rules of Procedure of the Customs Sub-Committee shall be based on the draft Decision of that sub-committee attached to this Decision.

2.   Minor technical corrections to the draft Decision may be agreed by the representatives of the Union in the Customs Sub-Committee without further decision of the Council.

Article 3

1.   The position to be taken on behalf of the Union within the Geographical Indications Sub-Committee established by Article 306 of the Agreement, as regards the adoption of the Rules of Procedure of the GI Sub-Committee shall be based on the draft Decision of that sub-committee attached to this Decision.

2.   Minor technical corrections to the draft Decision may be agreed by the representatives of the Union in the GI Sub-Committee without further decision of the Council.

Article 4

This Decision shall enter into force on the date of its adoption.

Done at Brussels, 27 January 2015.

For the Council

The President

J. REIRS

---

(1)  OJ L 260, 30.8.2014, p. 4.

1

(2)  Council Decision 2014/492/EU of 16 June 2014 on the signing, on behalf of the European Union, and provisional application of the Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and the Republic of Moldova, of the other part (OJ L 260, 30.8.2014, p. 1).

2

---

DRAFT

DECISION No 1/2015 OF THE EU-REPUBLIC OF MOLDOVA SANITARY AND PHYTOSANITARY SUB-COMMITTEE

of ... 2015

adopting its Rules of Procedure

THE EU-REPUBLIC OF MOLDOVA SANITARY AND PHYTOSANITARY SUB-COMMITTEE,

Having regard to the Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and the Republic of Moldova, of the other part (1) (‘the Agreement’), and in particular Article 191 thereof,

Whereas:

| (1) | In accordance with Article 464 of the Agreement, parts of the Agreement have been applied provisionally as of 1 September 2014. |
| --- | --- |

(1)

In accordance with Article 464 of the Agreement, parts of the Agreement have been applied provisionally as of 1 September 2014.

| (2) | Pursuant to Article 191(2) of the Agreement, the Sanitary and Phytosanitary Sub-Committee (‘SPS Sub-Committee’) is to consider any matter relating to the implementation of Chapter 4 (Sanitary and Phytosanitary Measures) of Title V (Trade and Trade-related Matters) of the Agreement. |
| --- | --- |

(2)

Pursuant to Article 191(2) of the Agreement, the Sanitary and Phytosanitary Sub-Committee (‘SPS Sub-Committee’) is to consider any matter relating to the implementation of Chapter 4 (Sanitary and Phytosanitary Measures) of Title V (Trade and Trade-related Matters) of the Agreement.

| (3) | Pursuant to Article 191(5) of the Agreement, the SPS Sub-Committee is to adopt its own rules of procedure, |
| --- | --- |

(3)

Pursuant to Article 191(5) of the Agreement, the SPS Sub-Committee is to adopt its own rules of procedure,

HAS ADOPTED THIS DECISION:

Article 1

The Rules of Procedure of the SPS Sub-Committee, as set out in the Annex, are hereby adopted.

Article 2

This Decision shall enter into force on the date of its adoption.

Done at ..., ....

For the SPS Sub-Committee

The Chair

---

(1)  OJ L 260, 30.8.2014, p. 4.

1

ANNEX

Rules of Procedure of the EU-Republic of Moldova Sanitary and Phytosanitary Sub-Committee

Article 1

General provisions

1.   The Sanitary and Phytosanitary Sub-Committee (‘SPS Sub-Committee’), established in accordance with Article 191(1) of the Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and the Republic of Moldova, of the other (‘the Agreement’) shall assist the Association Committee in Trade configuration, as set out in Article 438(4) of the Agreement (‘the Association Committee in Trade configuration’), in the performance of its duties.

2.   The SPS Sub-Committee shall perform the functions set out in Article 191(2) of the Agreement in the light of the objectives of Chapter 4 of Title V set out in Article 176 of the Agreement.

3.   The SPS Sub-Committee shall be composed of representatives of the European Commission and of the Republic of Moldova, responsible for sanitary and phytosanitary matters.

4.   A representative of the European Commission or of the Republic of Moldova who is responsible for sanitary and phytosanitary matters shall act as Chair of the SPS Sub-Committee in accordance with Article 2.

5.   The Parties in these Rules of Procedure shall be defined as provided for in Article 461 of the Agreement.

Article 2

Chairmanship

The Parties shall hold the chairmanship of the SPS Sub-Committee, alternately, for a period of 12 months. The first period shall begin on the date of the first Association Council meeting and end on 31 December of the same year.

Article 3

Meetings

1.   Save as otherwise agreed by the Parties, the SPS Sub-Committee shall meet within three months after the entry into force of the Agreement, at the request of either Party thereafter, or at least once a year.

2.   Each meeting of the SPS Sub-Committee shall be convened by its Chair at a place and on a date agreed by the Parties. The notice convening the meeting shall be issued by the Chair of the SPS Sub-Committee no later than 28 calendar days prior to the start of the meeting, unless the Parties agree otherwise.

3.   Whenever possible, the regular meeting of the SPS Sub-Committee shall be convened in due time in advance of the regular meeting of the Association Committee in Trade configuration.

4.   The meetings of the SPS Sub-Committee may be held by any agreed technological means such as video or audio-conference.

5.   The SPS Sub-Committee may address any issue out of session, by correspondence.

Article 4

Delegations

Before each meeting, the Parties shall be informed, by the Secretariat of the SPS Sub-Committee, of the intended composition of the delegation of each Party attending the meeting.

Article 5

Secretariat

1.   An official of the European Commission and an official of the Republic of Moldova shall act jointly as Secretaries of the SPS Sub-Committee and shall execute secretarial tasks in a joint manner, in a spirit of mutual trust and cooperation.

2.   The Secretariat of the Association Committee in Trade configuration shall be informed of any decisions, opinions, recommendations, reports and other agreed actions of the SPS Sub-Committee.

Article 6

Correspondence

1.   Correspondence addressed to the SPS Sub-Committee shall be directed to the Secretary of either Party, who in turn will inform the other Secretary.

2.   The Secretariat of the SPS Sub-Committee shall ensure that correspondence addressed to the SPS Sub-Committee is forwarded to the Chair of the SPS Sub-Committee and circulated, where appropriate, as documents referred to in Article 7.

3.   Correspondence from the Chair shall be sent to the Parties by the Secretariat on behalf of the Chair. Such correspondence shall be circulated, where appropriate, as provided for in Article 7.

Article 7

Documents

1.   Documents shall be circulated by the Secretaries of the SPS Sub-Committee.

2.   A Party shall transmit its documents to its Secretary. The Secretary shall transmit those documents to the Secretary of the other Party.

3.   The Secretary of the Union shall circulate the documents to the relevant representatives of the Union and shall systematically copy the Secretary of the Republic of Moldova and the Secretaries of the Association Committee in Trade configuration in such correspondence.

4.   The Secretary of the Republic of Moldova shall circulate the documents to the relevant representatives of the Republic of Moldova and shall systematically copy the Secretary of the Union and the Secretaries of the Association Committee in Trade configuration in such correspondence.

5.   The Secretaries of the SPS Sub-Committee shall serve as contact points for exchanges provided for in Article 184 of the Agreement.

Article 8

Confidentiality

Unless otherwise decided by the Parties, the meetings of the SPS Sub-Committee shall not be public. When a Party submits information designated as confidential to the SPS Sub-Committee, the other Party shall treat that information as such.

Article 9

Agendas for the meetings

1.   A provisional agenda for each meeting as well as draft operational conclusions as provided for in Article 10 shall be drawn up by the Secretariat of the SPS Sub-Committee on the basis of proposals made by the Parties. The provisional agenda shall include items in respect of which the Secretariat has received a request for inclusion in the agenda by a Party, supported by relevant documents, no later than 21 calendar days before the date of the meeting.

2.   The provisional agenda, together with the relevant documents, shall be circulated as provided for in Article 7 no later than 15 calendar days before the beginning of the meeting.

3.   The agenda shall be adopted by the SPS Sub-Committee at the beginning of each meeting. Items other than those appearing on the provisional agenda may be placed on the agenda if the Parties so agree.

4.   The Chair of the SPS Sub-Committee may, upon agreement of the other Party, invite representatives of other bodies of the Parties or independent experts in a subject area on an ad hoc basis to attend the meetings of the SPS Sub-Committee in order to provide information on specific subjects. The Parties shall ensure that those observers or experts respect any confidentiality requirements.

5.   The Chair of the SPS Sub-Committee may reduce the time limits specified in paragraphs 1 and 2, in consultation with the Parties, in order to take account of special circumstances.

Article 10

Minutes and operational conclusions

1.   Draft minutes of each meeting shall be drawn up jointly by the Secretaries of the SPS Sub-Committee.

2.   The minutes shall, as a general rule, include in respect of each item on the agenda:

| (a) | a list of participants at the meeting, a list of officials accompanying them and a list of any observers or experts who attended the meeting; |
| --- | --- |

(a)

a list of participants at the meeting, a list of officials accompanying them and a list of any observers or experts who attended the meeting;

| (b) | documentation submitted to the SPS Sub-Committee; |
| --- | --- |

(b)

documentation submitted to the SPS Sub-Committee;

| (c) | statements which the SPS Sub-Committee has asked to be entered in the minutes; and |
| --- | --- |

(c)

statements which the SPS Sub-Committee has asked to be entered in the minutes; and

| (d) | operational conclusions of the meeting, as provided for in paragraph 4. |
| --- | --- |

(d)

operational conclusions of the meeting, as provided for in paragraph 4.

3.   The draft minutes shall be submitted to the SPS Sub-Committee for approval. They shall be approved within 28 calendar days after each SPS Sub-Committee meeting. A copy shall be sent to each of the addressees referred to in Article 7.

4.   Draft operational conclusions of each meeting shall be drawn up by the Secretary of the SPS Sub-Committee of the Party holding the chairmanship of the SPS Sub-Committee, and circulated to the Parties together with the agenda, no later than 15 calendar days before the beginning of the meeting. That draft shall be updated as the meeting proceeds so that at the end of the meeting, unless agreed otherwise by the Parties, the SPS Sub-Committee adopts the operational conclusions, reflecting the follow-up actions agreed by the Parties. Once agreed, the operational conclusions shall be attached to the minutes and their implementation shall be reviewed during any subsequent meeting of the SPS Sub-Committee. To that end the SPS Sub-Committee shall adopt a template, allowing for each action to be tracked against a specific deadline.

Article 11

Decisions and recommendations

1.   The SPS Sub-Committee shall have the power to adopt decisions, opinions, recommendations, reports and joint actions as provided for in Article 191 of the Agreement. Those decisions, opinions, recommendations, reports and joint actions shall be adopted by consensus between the Parties after completion of the respective internal procedures for their adoption. The decisions shall be binding upon the Parties, who shall take appropriate measures to implement them.

2.   Each decision, opinion, recommendation or report shall be signed by the Chair of the SPS Sub-Committee and authenticated by the Secretaries of the SPS Sub-Committee. Without prejudice to paragraph 3, the Chair shall sign those documents during the meeting in which the relevant decision, opinion, recommendation or report is adopted.

3.   The SPS Sub-Committee may take decisions, make recommendations and adopt opinions or reports by written procedure, after completion of the respective internal procedures for their adoption, if the Parties so agree. The written procedure shall consist of an exchange of notes between the Secretaries, acting in agreement with the Parties. For that purpose, the text of the proposal shall be circulated pursuant to Article 7, with a time limit of no less than 21 calendar days within which any reservations or amendments shall be made known. The Chair may reduce that time limit, in consultation with the Parties, in order to take account of special circumstances. Once the text is agreed, the decision, the opinion, the recommendation or the report shall be signed by the Chair and authenticated by the Secretaries.

4.   The acts of the SPS Sub-Committee shall be entitled ‘Decision’, ‘Opinion’, ‘Recommendation’ or ‘Report’ respectively. Each decision shall enter into force on the date of its adoption unless the decision provides otherwise.

5.   The decisions, opinions, recommendations and reports shall be circulated to the Parties.

6.   Each Party may decide on the publication of the decisions, opinions and recommendations of the SPS Sub-Committee in its respective official publication.

Article 12

Reports

The SPS Sub-Committee shall submit a report to the Association Committee in Trade configuration on its activities and those of the technical working groups or the ad hoc groups set up by the SPS Sub-Committee. The report shall be submitted 25 calendar days before the regular annual meeting of the Association Committee in Trade configuration.

Article 13

Languages

1.   The working languages of the SPS Sub-Committee shall be English and Romanian.

2.   Unless otherwise decided, the SPS Sub-Committee shall base its deliberations on documentation prepared in those languages.

Article 14

Expenses

1.   Each Party shall meet any expenses it incurs as a result of participating in the meetings of the SPS Sub-Committee, both with regard to staff, travel and subsistence expenditure and with regard to postal and telecommunications expenditure.

2.   Expenditure in connection with the organisation of meetings and reproduction of documents shall be borne by the Party hosting the meeting.

3.   Expenditure in connection with interpreting at meetings and translation of documents into or from English and Romanian as referred to in Article 13(1) shall be borne by the Party hosting the meeting.

Interpreting and translation into or from other languages shall be borne directly by the requesting Party.

Article 15

Amendment of Rules of Procedure

These Rules of Procedure may be amended by a decision of the SPS Sub-Committee in accordance with Article 191(5) of the Agreement.

Article 16

Technical working groups and ad hoc groups

1.   The SPS Sub-Committee may by a decision pursuant to Article 191(6) of the Agreement create or abolish, where appropriate, technical working groups or ad hoc working groups, including scientific groups and expert groups.

2.   The membership of the ad hoc working groups need not be restricted to representatives of the Parties. The Parties shall ensure that the members of any groups created by the SPS Sub-Committee respect any appropriate confidentiality requirements.

3.   Unless otherwise decided by Parties, the groups created by the SPS Sub-Committee shall work under the authority of the SPS Sub-Committee, to which they shall report.

4.   The meetings of the working groups may be held as the need arises, in person or by a video or audio-conference.

5.   The Secretariat of the SPS Sub-Committee shall receive a copy of all relevant correspondence, documents and communications pertaining to the activities of the working groups.

6.   The working groups shall have the power to make recommendations in writing to the SPS Sub-Committee. The recommendations shall be made by consensus and communicated to the Chair of the SPS Sub-Committee, who shall circulate the recommendations as provided for in Article 7.

7.   These Rules of Procedure shall be applied mutatis mutandis to any technical working group or an ad hoc working group created by the SPS Sub-Committee, unless otherwise provided for in this Article. The references to the Association Committee in Trade Configuration shall be understood as references to the SPS Sub-Committee.

---

DRAFT

DECISION No 1/2015 OF THE EU-REPUBLIC OF MOLDOVA CUSTOMS SUB-COMMITTEE

of ... 2015

adopting its Rules of Procedure

THE EU-REPUBLIC OF MOLDOVA CUSTOMS SUB-COMMITTEE,

Having regard to the Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and the Republic of Moldova, of the other part (1) (‘the Agreement’), and in particular Article 200 thereof,

Whereas:

| (1) | In accordance with Article 464 of the Agreement, parts of the Agreement have been applied provisionally as of 1 September 2014. |
| --- | --- |

(1)

In accordance with Article 464 of the Agreement, parts of the Agreement have been applied provisionally as of 1 September 2014.

| (2) | Pursuant to Article 200 of the Agreement, the Customs Sub-Committee is to monitor the implementation and administration of Chapter 5 (Customs and Trade Facilitation) of Title V (Trade and Trade-related Matters) of the Agreement. |
| --- | --- |

(2)

Pursuant to Article 200 of the Agreement, the Customs Sub-Committee is to monitor the implementation and administration of Chapter 5 (Customs and Trade Facilitation) of Title V (Trade and Trade-related Matters) of the Agreement.

| (3) | Pursuant to Article 200(3)(e) of the Agreement, the Customs Sub-Committee is to adopt its own rules of procedure, |
| --- | --- |

(3)

Pursuant to Article 200(3)(e) of the Agreement, the Customs Sub-Committee is to adopt its own rules of procedure,

HAS ADOPTED THIS DECISION:

Article 1

The Rules of Procedure of the Customs Sub-Committee, as set out in the Annex, are hereby adopted.

Article 2

This Decision shall enter into force on the date of its adoption.

Done at ..., ....

For the Customs Sub-Committee

The Chair

---

(1)  OJ L 260, 30.8.2014, p. 4.

1

ANNEX

Rules of Procedure of the EU-Republic of Moldova Customs Sub-Committee

Article 1

General provisions

1.   The Customs Sub-Committee, established in accordance with Article 200(1) of the Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and the Republic of Moldova, of the other part (‘the Agreement’) shall perform its functions as provided for in Article 200(2) and (3) of the Agreement.

2.   The Customs Sub-Committee shall be composed of representatives of the European Commission and of the Republic of Moldova, responsible for customs and customs-related matters.

3.   A representative of the European Commission or of the Republic of Moldova who is responsible for customs and customs-related matters shall act as Chair in accordance with Article 2.

4.   The Parties in these Rules of Procedure shall be defined as provided for in Article 461 of the Agreement.

Article 2

Chairmanship

The Parties shall hold the chairmanship of the Customs Sub-Committee, alternately, for a period of 12 months. The first period shall begin on the date of the first Association Council meeting and end on 31 December of the same year.

Article 3

Meetings

1.   Save as otherwise agreed by the Parties, the Customs Sub-Committee shall meet once a year or at the request of either Party.

2.   Each meeting of the Customs Sub-Committee shall be convened by its Chair at a place and on a date agreed by the Parties. The notice convening the meeting shall be issued by the Chair of the Customs Sub-Committee no later than 28 calendar days prior to the start of the meeting, unless the Parties agree otherwise.

3.   The meetings of the Customs Sub-Committee may be held by any agreed technological means such as video or audio-conference.

4.   The Customs Sub-Committee may address any issue out of session, by correspondence.

Article 4

Delegations

Before each meeting, the Parties shall be informed, by the Secretariat of the Customs Sub-Committee, of the intended composition of the delegation of each Party attending the meeting.

Article 5

Secretariat

1.   An official of the European Commission and an official of the Republic of Moldova who are responsible for customs and customs-related matters shall act jointly as Secretaries of the Customs Sub-Committee and shall execute secretarial tasks in a joint manner, in a spirit of mutual trust and cooperation.

2.   The Secretariat of the Association Committee in Trade configuration, as set out in Article 438(4) of the Agreement (‘the Association Committee in Trade configuration’), shall be informed of any decisions, opinions, recommendations, reports and other agreed actions of the Customs Sub-Committee.

Article 6

Correspondence

1.   Correspondence addressed to the Customs Sub-Committee shall be directed to the Secretary of either Party, who in turn will inform the other Secretary.

2.   The Secretariat of the Customs Sub-Committee shall ensure that correspondence addressed to the Customs Sub-Committee is forwarded to the Chair of the Customs Sub-Committee and circulated, where appropriate, as documents referred to in Article 7.

3.   Correspondence from the Chair shall be sent to the Parties by the Secretariat on behalf of the Chair. Such correspondence shall be circulated, where appropriate, as provided for in Article 7.

Article 7

Documents

1.   Documents shall be circulated by the Secretaries of the Customs Sub-Committee.

2.   A Party shall transmit its documents to its Secretary. The Secretary shall transmit those documents to the Secretary of the other Party.

3.   The Secretary of the Union shall circulate the documents to the relevant representatives of the Union and shall systematically copy the Secretary of the Republic of Moldova in such correspondence. The Secretary of the Union shall send a copy of the final documents to the Secretaries of the Association Committee in Trade configuration.

4.   The Secretary of the Republic of Moldova shall circulate the documents to the relevant representatives of the Republic of Moldova and shall systematically copy the Secretary of the Union in such correspondence. The Secretary of the Republic of Moldova shall send a copy of the final documents to the Secretaries of the Association Committee in Trade configuration.

Article 8

Confidentiality

Unless otherwise decided by the Parties, the meetings of the Customs Sub-Committee shall not be public. When a Party submits information designated as confidential to the Customs Sub-Committee, the other Party shall treat that information as such.

Article 9

Agendas for the meetings

1.   A provisional agenda for each meeting shall be drawn up by the Secretariat of the Customs Sub-Committee on the basis of proposals made by the Parties. The provisional agenda shall include items in respect of which the Secretariat has received a request for inclusion in the agenda by a Party, supported by relevant documents, no later than 21 calendar days before the date of the meeting.

2.   The provisional agenda, together with the relevant documents, shall be circulated as provided for in Article 7 no later than 15 calendar days before the beginning of the meeting.

3.   The agenda shall be adopted by the Customs Sub-Committee at the beginning of each meeting. Items other than those appearing on the provisional agenda may be placed on the agenda if the Parties so agree.

4.   The Chair of the Customs Sub-Committee may, upon agreement of the other Party, invite representatives of other bodies of the Parties or independent experts in a subject area on an ad hoc basis to attend its meetings in order to provide information on specific subjects. The Parties shall ensure that those observers or experts respect any confidentiality requirements.

5.   The Chair of the Customs Sub-Committee may reduce the time limits specified in paragraphs 1 and 2, in consultation with the Parties, in order to take account of special circumstances.

Article 10

Minutes and operational conclusions

1.   Draft minutes, including operational conclusions, of each meeting shall be drawn up by the Secretary of the Customs Sub-Committee of the Party holding the chairmanship of the Customs Sub-Committee.

2.   The draft minutes, including the operational conclusions, shall be submitted to the Customs Sub-Committee for approval. The draft minutes shall be approved within 28 calendar days after each Customs Sub-Committee meeting. A copy shall be sent to each of the addressees referred to in Article 7.

Article 11

Decisions and recommendations

1.   The Customs Sub-Committee shall have the power to adopt practical arrangements, measures, decisions and recommendations as provided for in Article 200 of the Agreement. Those practical arrangements, measures, decisions and recommendations shall be adopted by consensus between the Parties after completion of the respective internal procedures for their adoption. The decisions shall be binding upon the Parties, who shall take appropriate measures to implement them.

2.   Each decision or recommendation shall be signed by the Chair of the Customs Sub-Committee and authenticated by the Secretaries of the Customs Sub-Committee. Without prejudice to paragraph 3, the Chair shall sign those documents during the meeting in which the relevant decision or recommendation is adopted.

3.   The Customs Sub-Committee may take decisions or make recommendations by written procedure, after completion of the respective internal procedures for their adoption, if the Parties so agree. The written procedure shall consist of an exchange of notes between the Secretaries, acting in agreement with the Parties. For that purpose, the text of the proposal shall be circulated pursuant to Article 7, with a time limit of no less than 21 calendar days within which any reservations or amendments shall be made known. The Chair may reduce that time limit, in consultation with the Parties, in order to take account of special circumstances. Once the text is agreed, the decision or the recommendation shall be signed by the Chair and authenticated by the Secretaries.

4.   The acts of the Customs Sub-Committee shall be entitled ‘Decision’ or ‘Recommendation’ respectively. Each decision shall enter into force on the date of its adoption unless the decision provides otherwise.

5.   The decisions and recommendations shall be circulated to the Parties.

6.   Each Party may decide on the publication of the decisions and recommendations of the Customs Sub-Committee in its respective official publication.

Article 12

Reports

The Customs Sub-Committee shall report to the Association Committee in Trade configuration at each regular annual meeting of the Association Committee in Trade configuration.

Article 13

Languages

1.   The working languages of the Customs Sub-Committee shall be English and Romanian.

2.   Unless otherwise decided, the Customs Sub-Committee shall base its deliberations on documentation prepared in those languages.

Article 14

Expenses

1.   Each Party shall meet any expenses it incurs as a result of participating in the meetings of the Customs Sub-Committee, both with regard to staff, travel and subsistence expenditure and with regard to postal and telecommunications expenditure.

2.   Expenditure in connection with the organisation of meetings and reproduction of documents shall be borne by the Party hosting the meeting.

3.   Expenditure in connection with interpreting at meetings and translation of documents into or from English and Romanian as referred to in Article 13(1) shall be borne by the Party hosting the meeting.

Interpreting and translation into or from other languages shall be borne directly by the requesting Party.

Article 15

Amendment of Rules of Procedure

These Rules of Procedure may be amended by a decision of the Customs Sub-Committee in accordance with Article 200(3)(e) of the Agreement.

---

DRAFT

DECISION No 1/2015 OF THE EU-REPUBLIC OF MOLDOVA GEOGRAPHICAL INDICATIONS SUB-COMMITTEE

of ... 2015

adopting its Rules of Procedure

THE EU-REPUBLIC OF MOLDOVA GEOGRAPHICAL INDICATIONS SUB-COMMITTEE,

Having regard to the Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and the Republic of Moldova, of the other part (1) (‘the Agreement’), and in particular Article 306 thereof,

Whereas:

| (1) | In accordance with Article 464 of the Agreement, parts of the Agreement have been applied provisionally as of 1 September 2014. |
| --- | --- |

(1)

In accordance with Article 464 of the Agreement, parts of the Agreement have been applied provisionally as of 1 September 2014.

| (2) | Pursuant to Article 306 of the Agreement, the Geographical Indications Sub-Committee (‘GI Sub-Committee’) is to monitor the development of the Agreement in the field of geographical indications and is to serve as a forum for cooperation and dialogue on geographical indications. |
| --- | --- |

(2)

Pursuant to Article 306 of the Agreement, the Geographical Indications Sub-Committee (‘GI Sub-Committee’) is to monitor the development of the Agreement in the field of geographical indications and is to serve as a forum for cooperation and dialogue on geographical indications.

| (3) | Pursuant to Article 306(3) of the Agreement, the GI Sub-Committee is to determine its own rules of procedure, |
| --- | --- |

(3)

Pursuant to Article 306(3) of the Agreement, the GI Sub-Committee is to determine its own rules of procedure,

HAS ADOPTED THIS DECISION:

Article 1

The Rules of Procedure for the GI Sub-Committee, as set out in the Annex, are hereby adopted.

Article 2

This Decision shall enter into force on the date of its adoption.

Done at ...,

For the GI Sub-Committee

The Chair

---

(1)  OJ L 260, 30.8.2014, p. 4.

1

ANNEX

Rules of Procedure of the EU-Republic of Moldova Geographical Indications Sub-Committee

Article 1

General provisions

1.   The Geographical Indications Sub-Committee (‘GI Sub-Committee’), established in accordance with Article 306 of the Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and the Republic of Moldova, of the other part (‘the Agreement’) shall assist the Association Committee in Trade configuration, as set out in Article 438(4) of the Agreement (‘the Association Committee in Trade configuration’), in the performance of its functions.

2.   The GI Sub-Committee shall perform its functions set out in Article 306 of the Agreement.

3.   The GI Sub-Committee shall be composed of representatives of the European Commission and of the Republic of Moldova, responsible for matters relating to geographical indications.

4.   The Parties shall each appoint a Head of Delegation who shall be the contact person for all matters relating to the GI Sub-Committee.

5.   The Heads of Delegation shall act as Chair of the GI Sub-Committee in accordance with Article 2.

6.   Each Head of Delegation may delegate all or any of the functions of Head of Delegation to a nominated deputy, in which case all references hereafter to the Head of Delegation apply equally to the nominated deputy.

7.   The Parties in these Rules of Procedure shall be defined as provided for in Article 461 of the Agreement.

Article 2

Chairmanship

The Parties shall hold the chairmanship of the GI Sub-Committee, alternately, for a period of 12 months. The first period shall begin on the date of the first Association Council meeting and end on 31 December of the same year.

Article 3

Meetings

1.   Save as otherwise agreed by the Parties, the GI Sub-Committee shall meet at the request of either Party, alternately in the Union and in the Republic of Moldova, and in any case no later than 90 calendar days from the request.

2.   Each meeting of the GI Sub-Committee shall be convened by its Chair at a place and on a date agreed by the Parties. The notice of convening the meeting shall be issued by the Chair of the GI Sub-Committee no later than 28 calendar days prior to the start of the meeting, unless the Parties agree otherwise.

3.   Whenever possible, the regular meeting of the GI Sub-Committee shall be convened in due time in advance of the regular meeting of the Association Committee in Trade configuration.

4.   By way of exception, the meetings of the GI Sub-Committee may be held by any technological means agreed by the Parties, including video-conference.

Article 4

Delegations

Before each meeting, the Parties shall be informed, by the Secretariat of the GI Sub-Committee, of the intended composition of the delegation of each Party attending the meeting.

Article 5

Secretariat

1.   An official of the European Commission and an official of the Republic of Moldova shall act jointly as Secretaries of the GI Sub-Committee, as appointed by the Heads of Delegations, and shall execute secretarial tasks in a joint manner, in a spirit of mutual trust and cooperation.

2.   The Secretariat of the Association Committee in Trade configuration shall be informed of any decisions, reports and other agreed actions of the GI Sub-Committee.

Article 6

Correspondence

1.   Correspondence addressed to the GI Sub-Committee shall be directed to the Secretary of either Party, who in turn will inform the other Secretary.

2.   The Secretariat of the GI Sub-Committee shall ensure that correspondence addressed to the GI Sub-Committee is forwarded to the Chair of the GI Sub-Committee and circulated, where appropriate, as documents referred to in Article 7.

3.   Correspondence from the Chair shall be sent to the Parties by the Secretariat on behalf of the Chair. Such correspondence shall be circulated, where appropriate, as provided for in Article 7.

Article 7

Documents

1.   Documents shall be circulated by the Secretaries of the GI Sub-Committee.

2.   A Party shall transmit its documents to its Secretary. The Secretary shall transmit those documents to the Secretary of the other Party.

3.   The Secretary of the Union shall circulate the documents to the relevant representatives of the Union and shall systematically copy the Secretary of the Republic of Moldova and the Secretaries of the Association Committee in Trade configuration in such correspondence.

4.   The Secretary of the Republic of Moldova shall circulate the documents to the relevant representatives of the Republic of Moldova and shall systematically copy the Secretary of the Union and the Secretaries of the Association Committee in Trade configuration in such correspondence.

Article 8

Confidentiality

Unless otherwise decided by the Parties, the meetings of the GI Sub-Committee shall not be public. When a Party submits information designated as confidential to the GI Sub-Committee, the other Party shall treat that information as such.

Article 9

Agendas for the meetings

1.   A provisional agenda for each meeting as well as draft operational conclusions as provided for in Article 10 shall be drawn up by the Secretariat of the GI Sub-Committee on the basis of proposals made by the Parties. The provisional agenda shall include items in respect of which the Secretariat has received a request for inclusion in the agenda by a Party, supported by relevant documents, no later than 21 calendar days before the date of the meeting.

2.   The provisional agenda, together with the relevant documents, shall be circulated as provided for in Article 7 no later than 15 calendar days before the beginning of the meeting.

3.   The agenda shall be adopted by the Chair and the other Head of Delegation at the beginning of each meeting. Items other than those appearing on the provisional agenda may be placed on the agenda if the Parties so agree.

4.   The Chair of the GI Sub-Committee may, upon agreement of the other Party, invite representatives of other bodies of the Parties or independent experts in a subject-area on an ad hoc basis to attend its meetings in order to provide information on specific subjects. The Parties shall ensure that those observers or experts respect any confidentiality requirements.

5.   The Chair of the GI Sub-Committee may reduce the time limits specified in paragraphs 1 and 2, in consultation with the Parties, in order to take account of special circumstances.

Article 10

Minutes and operational conclusions

1.   Draft minutes of each meeting shall be drawn up jointly by the Secretaries of the GI Sub-Committee.

2.   The minutes shall, as a general rule, include in respect of each item on the agenda:

| (a) | a list of participants in the meeting, a list of officials accompanying them and a list of any observers or experts who attended the meeting; |
| --- | --- |

(a)

a list of participants in the meeting, a list of officials accompanying them and a list of any observers or experts who attended the meeting;

| (b) | documentation submitted to the GI Sub-Committee; |
| --- | --- |

(b)

documentation submitted to the GI Sub-Committee;

| (c) | statements which the GI Sub-Committee has asked to be entered in the minutes; and |
| --- | --- |

(c)

statements which the GI Sub-Committee has asked to be entered in the minutes; and

| (d) | operational conclusions of the meeting, if necessary, as provided for in paragraph 4. |
| --- | --- |

(d)

operational conclusions of the meeting, if necessary, as provided for in paragraph 4.

3.   The draft minutes shall be submitted to the GI Sub-Committee for approval. They shall be approved within 28 calendar days after each GI Sub-Committee meeting. A copy shall be sent to each of the addressees referred to in Article 7.

4.   Draft operational conclusions of each meeting shall be drawn up by the Secretary of the GI Sub-Committee of the Party holding the chairmanship of the GI Sub-Committee, and circulated to the Parties together with the agenda, no later than 15 calendar days before the beginning of the meeting. That draft shall be updated as the meeting proceeds so that at the end of the meeting, unless agreed otherwise by the Parties, the GI Sub-Committee adopts the operational conclusions, reflecting the follow-up actions agreed by the Parties. Once agreed, the operational conclusions shall be attached to the minutes and their implementation shall be reviewed during any subsequent meeting of the GI Sub-Committee. To that end the GI Sub-Committee shall adopt a template, allowing for each action to be tracked against a specific deadline.

Article 11

Decisions

1.   The GI Sub-Committee shall have the power to adopt decisions in the cases provided for in Article 306(4) of the Agreement. Those decisions shall be adopted by consensus between the Parties after completion of the respective internal procedures for their adoption. They shall be binding upon the Parties, which shall take appropriate measures to implement them.

2.   Each decision shall be signed by the Chair of the GI Sub-Committee and authenticated by the Secretaries of the GI Sub-Committee. Without prejudice to paragraph 4, the Chair shall sign those documents during the meeting in which the relevant decision is adopted.

3.   The GI Sub-Committee may take decisions or adopt reports by written procedure, after completion of the respective internal procedures for their adoption, if the Parties so agree. The written procedure shall consist of an exchange of notes between the Secretaries, acting in agreement with the Parties. For that purpose, the text of the proposal shall be circulated pursuant to Article 7, with a time limit of no less than 21 calendar days within which any reservations or amendments shall be made known. The Chair may reduce that time limit, in consultation with the Parties, in order to take account of special circumstances. Once the text is agreed, the decision or the report shall be signed by the Chair and authenticated by the Secretaries.

4.   The acts of the GI Sub-Committee shall be entitled ‘Decision’ or ‘Report’ respectively. Each decision shall enter into force on the date of its adoption unless the decision provides otherwise.

5.   The decisions shall be circulated to the Parties.

6.   Each Party may decide on the publication of the decisions of the GI Sub-Committee in its respective official publication.

Article 12

Reports

The GI Sub-Committee shall report to the Association Committee in Trade configuration on its activities at each regular meeting of the latter.

Article 13

Languages

1.   The working languages of the GI Sub-Committee shall be English and Romanian.

2.   Unless otherwise decided, the GI Sub-Committee shall base its deliberations on documentation prepared in those languages.

Article 14

Expenses

1.   Each Party shall meet any expenses it incurs as a result of participating in the meetings of the GI Sub-Committee, both with regard to staff, travel and subsistence expenditure and with regards to postal and telecommunications expenditure.

2.   Expenditure in connection with the organisation of meetings and reproduction of documents shall be borne by the Party hosting the meeting.

3.   Expenditure in connection with interpreting at meetings and translation of documents into or from English and Romanian as referred to in Article 13(1) shall be borne by the Party hosting the meeting.

Interpreting and translation into or from other languages shall be borne directly by the requesting Party.

Article 15

Amendment of Rules of Procedure

These Rules of Procedure may be amended by a decision of the GI Sub-Committee in accordance with Article 306(3) of the Agreement.

---

| 6.2.2015 | EN | Official Journal of the European Union | L 30/38 |
| --- | --- | --- | --- |

6.2.2015

EN

Official Journal of the European Union

L 30/38

---

COMMISSION IMPLEMENTING DECISION (EU) 2015/179

of 4 February 2015

authorising Member States to provide for a derogation from certain provisions of Council Directive 2000/29/EC in respect of wood packaging material of conifers (Coniferales) in the form of ammunition boxes originating in the United States of America under the control of the United States Department of Defence

(notified under document C(2015) 445)

THE EUROPEAN COMMISSION,

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

Having regard to Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (1), and in particular the first indent of Article 15(1) thereof,

Whereas:

| (1) | In accordance with Article 5(1) of Directive 2000/29/EC in conjunction with point 2 of Section I of Part A of Annex IV thereto, Member States shall ban the introduction into the Union of wood packaging material unless it has been subjected to an approved phytosanitary treatment as specified in the International Standard for Phytosanitary Measures No 15 (2) and displays a mark, as specified within the same Standard, indicating that the wood packaging material has been subjected to such a phytosanitary treatment. Pursuant to Article 15(1) of that Directive derogations from those provisions may, however, be provided for if it is established that there is no risk of spreading harmful organisms. |
| --- | --- |

(1)

In accordance with Article 5(1) of Directive 2000/29/EC in conjunction with point 2 of Section I of Part A of Annex IV thereto, Member States shall ban the introduction into the Union of wood packaging material unless it has been subjected to an approved phytosanitary treatment as specified in the International Standard for Phytosanitary Measures No 15 (2) and displays a mark, as specified within the same Standard, indicating that the wood packaging material has been subjected to such a phytosanitary treatment. Pursuant to Article 15(1) of that Directive derogations from those provisions may, however, be provided for if it is established that there is no risk of spreading harmful organisms.

| (2) | Certain wood packaging material of conifers (Coniferales) in the form of boxes actually in use in the transport of ammunition, which were manufactured on 31 August 2007 at the latest and originating from the United States, does not fulfil the conditions set out in Article 5(1) of Directive 2000/29/EC in conjunction with point 2 of Section I of Part A of Annex IV thereto. Hereinafter those boxes are referred to as ‘the boxes’. |
| --- | --- |

(2)

Certain wood packaging material of conifers (Coniferales) in the form of boxes actually in use in the transport of ammunition, which were manufactured on 31 August 2007 at the latest and originating from the United States, does not fulfil the conditions set out in Article 5(1) of Directive 2000/29/EC in conjunction with point 2 of Section I of Part A of Annex IV thereto. Hereinafter those boxes are referred to as ‘the boxes’.

| (3) | The Commission has concluded on the basis of information supplied by the United States that the boxes do not present any risk of spreading harmful organisms, provided that certain conditions are satisfied concerning absence or limited presence of bark, treatment and repair of the boxes as well as their storage and transport. |
| --- | --- |

(3)

The Commission has concluded on the basis of information supplied by the United States that the boxes do not present any risk of spreading harmful organisms, provided that certain conditions are satisfied concerning absence or limited presence of bark, treatment and repair of the boxes as well as their storage and transport.

| (4) | Therefore, Member States should be authorised to allow the boxes to be introduced into, as well as stored and moved within, their territory provided that the conditions referred to in recital 3 are satisfied, while the provisions of Directive 2000/29/EC should apply after they become empty. |
| --- | --- |

(4)

Therefore, Member States should be authorised to allow the boxes to be introduced into, as well as stored and moved within, their territory provided that the conditions referred to in recital 3 are satisfied, while the provisions of Directive 2000/29/EC should apply after they become empty.

| (5) | In order to ensure effective controls and overview of the potential phytosanitary risks, any person moving or storing the boxes after the checks provided for in the enacting terms should notify the responsible official body concerning that movement or storage, and the boxes concerned. |
| --- | --- |

(5)

In order to ensure effective controls and overview of the potential phytosanitary risks, any person moving or storing the boxes after the checks provided for in the enacting terms should notify the responsible official body concerning that movement or storage, and the boxes concerned.

| (6) | Member States should inform each other and the Commission when they become aware of a consignment not complying with the conditions referred to in recital 3. They should, on an annual basis, provide the Commission and the other Member States with information on the imports made, in order to assess the application of this Decision. |
| --- | --- |

(6)

Member States should inform each other and the Commission when they become aware of a consignment not complying with the conditions referred to in recital 3. They should, on an annual basis, provide the Commission and the other Member States with information on the imports made, in order to assess the application of this Decision.

| (7) | Taking into account the reasons for the derogation, it is appropriate to authorise it for a period of three years. |
| --- | --- |

(7)

Taking into account the reasons for the derogation, it is appropriate to authorise it for a period of three years.

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

(8)

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

HAS ADOPTED THIS DECISION:

Article 1

Authorisation to provide for derogation

By way of derogation from Article 5(1) of Directive 2000/29/EC in conjunction with point 2 of Section I of Part A of Annex IV to that Directive, Member States may authorise the introduction into their territory of wood packaging material of conifers (Coniferales) in the form of boxes, actually in use in the transport of ammunition, which were manufactured on 31 August 2007 at the latest and originating in the United States of America under the control of the United States Department of Defence, hereinafter ‘the boxes’, which satisfy the conditions set out in the Annex to this Decision.

Article 2

Notification obligation

1.   The importer shall, at least five working days in advance, notify the responsible official body of the Member State or Member States of the point of entry and the first place of storage, other than the point of entry, of its intention to introduce a consignment.

2.   The notification referred to in paragraph 1 shall include the following elements:

| (a) | date of intended introduction; |
| --- | --- |

(a)

date of intended introduction;

| (b) | an inventory of the consignment concerned identifying the boxes forming part of it; |
| --- | --- |

(b)

an inventory of the consignment concerned identifying the boxes forming part of it;

| (c) | name and address of importer; |
| --- | --- |

(c)

name and address of importer;

| (d) | point of entry of intended introduction; |
| --- | --- |

(d)

point of entry of intended introduction;

| (e) | address of the first place of storage, other than the point of entry. |
| --- | --- |

(e)

address of the first place of storage, other than the point of entry.

Article 3

Checks by the responsible official bodies

The responsible official body of the Member State of the first place of storage, other than the point of entry, shall check compliance of a representative sample of each consignment with the following points of the Annex:

| (a) | points (1) and (2) concerning the display of the respective marks; |
| --- | --- |

(a)

points (1) and (2) concerning the display of the respective marks;

| (b) | point (4) concerning bark freedom; |
| --- | --- |

(b)

point (4) concerning bark freedom;

| (c) | point (5) concerning the moisture content level; |
| --- | --- |

(c)

point (5) concerning the moisture content level;

| (d) | point (7) concerning the accompanying document. |
| --- | --- |

(d)

point (7) concerning the accompanying document.

Article 4

Storage and movement

1.   Prior to and after the conduct of the checks, as referred to in Article 3, the boxes shall remain stored in closed buildings.

2.   In case the boxes are moved prior to or after the checks, as referred to in Article 3, they shall be moved in closed containers, or under full protective cover.

3.   In case the boxes are moved after the checks, as referred to in Article 3, the person moving them shall notify the responsible official body or the responsible official bodies as regards the place of departure and the place of destination, as well as the quantities and identity of the boxes concerned.

In case the boxes are stored after the checks, as referred to in Article 3, at a place different from the place where those checks have been carried out, the person storing them shall notify the responsible official body as regards the place of storage as well as the quantities and identity of the boxes concerned.

Article 5

Notification of non-compliance

Member States shall notify the Commission and the other Member States of each consignment not complying with the conditions set out in the Annex.

That notification shall take place no later than three working days after the date when the responsible official body becomes aware of such a consignment.

Article 6

Reporting on imports

The Member State of the first place of storage, other than the point of entry, as referred to in Article 2(1), shall provide the Commission and the other Member States, by 31 January of each year, with information on the number of consignments introduced into their territories and a report on the checks referred to in Article 3 carried out between 1 January and 31 December of the preceding year.

Article 7

Expiry date

This Decision shall expire on 31 December 2017.

Article 8

Addressees

This Decision is addressed to the Member States.

Done at Brussels, 4 February 2015.

For the Commission

Vytenis ANDRIUKAITIS

Member of the Commission

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(1)  OJ L 169, 10.7.2000, p. 1.

1

(2)  ISPM 15. 2009. Regulation of wood packaging material in international trade. Rome, IPPC, FAO.

2

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ANNEX

CONDITIONS FOR THE BOXES AS REFERRED TO IN ARTICLE 1

The boxes referred to in Article 1 shall satisfy the following conditions:

| (1) | They display a mark confirming that they have been manufactured on 31 August 2007 at the latest. |
| --- | --- |

(1)

They display a mark confirming that they have been manufactured on 31 August 2007 at the latest.

| (2) | They display a mark indicating that they have been treated with a wood preservative approved by the Environmental Protection Agency of the United States of America. |
| --- | --- |

(2)

They display a mark indicating that they have been treated with a wood preservative approved by the Environmental Protection Agency of the United States of America.

| (3) | In case the boxes have been repaired since 1 September 2007 the wood used, for that purpose, fulfils the conditions set out in point 2 of Section I of Part A of Annex IV to Directive 2000/29/EC. |
| --- | --- |

(3)

In case the boxes have been repaired since 1 September 2007 the wood used, for that purpose, fulfils the conditions set out in point 2 of Section I of Part A of Annex IV to Directive 2000/29/EC.

| (4) | The boxes are made of debarked wood, with the exception of any number of visually separate and clearly distinct small pieces of bark which comply with one of the following requirements:






  (a) | they are less than 3 cm in width (regardless of the length); or |
| --- | --- | --- |

(4)

The boxes are made of debarked wood, with the exception of any number of visually separate and clearly distinct small pieces of bark which comply with one of the following requirements:

(a)

they are less than 3 cm in width (regardless of the length); or

| (b) | if they are greater than 3 cm in width, the total surface area of each individual piece of bark is less than 50 cm2. |
| --- | --- |

(b)

if they are greater than 3 cm in width, the total surface area of each individual piece of bark is less than 50 cm2.

| (5) | Their moisture content level is no more than 20 %. |
| --- | --- |

(5)

Their moisture content level is no more than 20 %.

| (6) | They have always been stored in closed buildings and transported in closed containers, or under full protective cover. |
| --- | --- |

(6)

They have always been stored in closed buildings and transported in closed containers, or under full protective cover.

| (7) | They are accompanied by a document issued by the United States Department of Defence confirming compliance with the conditions set out in points (4), (5) and (6). |
| --- | --- |

(7)

They are accompanied by a document issued by the United States Department of Defence confirming compliance with the conditions set out in points (4), (5) and (6).

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