# Official Journal L 288/2020

| | ISSN 1977-0677 |
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| Official Journal
  of the European Union | L 288 |
| | |
| English edition | Legislation | Volume 633 September 2020 |

ISSN 1977-0677

Official Journal

of the European Union

L 288

English edition

Legislation

Volume 633 September 2020

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| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | * | Commission Regulation (EU) 2020/1245 of 2 September 2020 amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food (
  1
  ) | 1 |
| | * | Commission Implementing Regulation (EU) 2020/1246 of 2 September 2020 concerning the non-renewal of the approval of the active substance fenamiphos, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (
  1
  ) | 18 |
| | * | Commission Implementing Regulation (EU) 2020/1247 of 2 September 2020 operating deductions from fishing quotas available for certain stocks in 2020 on account of overfishing in the previous years | 21 |

Contents

II   Non-legislative acts

page

REGULATIONS

*

Commission Regulation (EU) 2020/1245 of 2 September 2020 amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food (
  1
  )

1

1

*

Commission Implementing Regulation (EU) 2020/1246 of 2 September 2020 concerning the non-renewal of the approval of the active substance fenamiphos, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (
  1
  )

1

18

*

Commission Implementing Regulation (EU) 2020/1247 of 2 September 2020 operating deductions from fishing quotas available for certain stocks in 2020 on account of overfishing in the previous years

21

| | | III   Other acts |
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| | | EUROPEAN ECONOMIC AREA |
| | * | EFTA Surveillance Authority Delegated Decision No 47/20/COL of 25 May 2020 authorising Norway to derogate from certain common aviation safety rules pursuant to Article 14(6) of Regulation (EC) No 216/2008 [2020/1248] | 26 |

III   Other acts

EUROPEAN ECONOMIC AREA

*

EFTA Surveillance Authority Delegated Decision No 47/20/COL of 25 May 2020 authorising Norway to derogate from certain common aviation safety rules pursuant to Article 14(6) of Regulation (EC) No 216/2008 [2020/1248]

26

| | | Corrigenda |
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| | * | Corrigendum to Regulation (EU) 2018/1861 of the European Parliament and of the Council of 28 November 2018 on the establishment, operation and use of the Schengen Information System (SIS) in the field of border checks, and amending the Convention implementing the Schengen Agreement, and amending and repealing Regulation (EC) No 1987/2006 ( OJ L 312, 7.12.2018 ) | 29 |

Corrigenda

*

Corrigendum to Regulation (EU) 2018/1861 of the European Parliament and of the Council of 28 November 2018 on the establishment, operation and use of the Schengen Information System (SIS) in the field of border checks, and amending the Convention implementing the Schengen Agreement, and amending and repealing Regulation (EC) No 1987/2006 ( OJ L 312, 7.12.2018 )

( OJ L 312, 7.12.2018 )

29

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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

REGULATIONS

| 3.9.2020 | EN | Official Journal of the European Union | L 288/1 |
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3.9.2020

EN

Official Journal of the European Union

L 288/1

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COMMISSION REGULATION (EU) 2020/1245

of 2 September 2020

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), (d), (e), (h) and (i) of Article 5(1), Article 11(3) and Article 12(6) thereof,

Whereas:

| (1) | Commission Regulation (EU) No 10/2011 (2) (‘the Regulation’) lays down specific rules as regards plastic materials and articles intended to come into contact with foods. In particular, Annex I to the Regulation establishes a Union list of substances that may be used in the manufacture of plastic food contact materials and articles, while Annex II establishes additional restrictions applicable to plastic materials and articles. |
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(1)

Commission Regulation (EU) No 10/2011 (2) (‘the Regulation’) lays down specific rules as regards plastic materials and articles intended to come into contact with foods. In particular, Annex I to the Regulation establishes a Union list of substances that may be used in the manufacture of plastic food contact materials and articles, while Annex II establishes additional restrictions applicable to plastic materials and articles.

| (2) | Since the last amendment to the Regulation, the European Food Safety Authority (‘the Authority’) has published further scientific opinions on particular substances that may be used in food contact materials (‘FCM’) as well as on the use of already authorised substances. In addition, certain ambiguities to the application of the Regulation were identified. In order to ensure that the Regulation takes account of the most recent findings of the Authority and in order to remove any doubt as regards its correct application, the Regulation should be amended and corrected. |
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(2)

Since the last amendment to the Regulation, the European Food Safety Authority (‘the Authority’) has published further scientific opinions on particular substances that may be used in food contact materials (‘FCM’) as well as on the use of already authorised substances. In addition, certain ambiguities to the application of the Regulation were identified. In order to ensure that the Regulation takes account of the most recent findings of the Authority and in order to remove any doubt as regards its correct application, the Regulation should be amended and corrected.

| (3) | The Authority adopted a favourable scientific opinion (3) on the use of isostructural salt complexes of terephthalic acid (generically described as 1,4-benzene dicarboxylic acid, FCM substance No 785) with the following lanthanides: lanthanum (La), europium (Eu), gadolinium (Gd) and terbium (Tb) used alone or in combination and in varying proportions, as additives in plastics intended to come into contact with foods. The Authority concluded that those salts are not of a safety concern for the consumer if used as additives in polyethylene, polypropylene or polybutene plastic materials and articles intended to come into contact with all food types under contact conditions of up to 4 hours at 100 °C or for long-term storage at ambient temperature. This conclusion is made on the basis that, if migration from the plastic food contact material to the food or food simulant were to occur, the lanthanides should be present in the food or the food simulant in dissociated ionic form and the migration of the sum of the four lanthanide ions (La, Eu, Gd, Tb) when used alone or in combination should not exceed 0,05 mg/kg food. |
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(3)

The Authority adopted a favourable scientific opinion (3) on the use of isostructural salt complexes of terephthalic acid (generically described as 1,4-benzene dicarboxylic acid, FCM substance No 785) with the following lanthanides: lanthanum (La), europium (Eu), gadolinium (Gd) and terbium (Tb) used alone or in combination and in varying proportions, as additives in plastics intended to come into contact with foods. The Authority concluded that those salts are not of a safety concern for the consumer if used as additives in polyethylene, polypropylene or polybutene plastic materials and articles intended to come into contact with all food types under contact conditions of up to 4 hours at 100 °C or for long-term storage at ambient temperature. This conclusion is made on the basis that, if migration from the plastic food contact material to the food or food simulant were to occur, the lanthanides should be present in the food or the food simulant in dissociated ionic form and the migration of the sum of the four lanthanide ions (La, Eu, Gd, Tb) when used alone or in combination should not exceed 0,05 mg/kg food.

| (4) | The Authority noted that, in light of the chemical characteristics of the isostructural lanthanide salts of terephthalic acid and of the four lanthanides (La, Eu, Gd, Tb) themselves, it is not necessary to restrict the use of these additives to the three polyolefin types of plastics specified in the application dossier that the applicant provided to the Authority. The Authority reasoned that no undesirable interactions with plastics (including, but not limited to polyolefins) leading to formation and possible migration of undesirable reaction and transformation products are to be expected. Like polyolefins, if migration from any plastic food contact material to the food or food simulant were to occur, the lanthanides should be present in the food or the food simulant in dissociated ionic form and the migration of the sum of the four lanthanide ions (La, Eu, Gd, Tb) when used alone or in combination should not exceed 0,05 mg/kg food, and no further restrictions should be necessary. Therefore, it is appropriate to authorise the lanthanides for use in all types of plastic materials and articles as salts of already authorised substances, provided that these restrictions are met. |
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(4)

The Authority noted that, in light of the chemical characteristics of the isostructural lanthanide salts of terephthalic acid and of the four lanthanides (La, Eu, Gd, Tb) themselves, it is not necessary to restrict the use of these additives to the three polyolefin types of plastics specified in the application dossier that the applicant provided to the Authority. The Authority reasoned that no undesirable interactions with plastics (including, but not limited to polyolefins) leading to formation and possible migration of undesirable reaction and transformation products are to be expected. Like polyolefins, if migration from any plastic food contact material to the food or food simulant were to occur, the lanthanides should be present in the food or the food simulant in dissociated ionic form and the migration of the sum of the four lanthanide ions (La, Eu, Gd, Tb) when used alone or in combination should not exceed 0,05 mg/kg food, and no further restrictions should be necessary. Therefore, it is appropriate to authorise the lanthanides for use in all types of plastic materials and articles as salts of already authorised substances, provided that these restrictions are met.

| (5) | Article 6(3)(a) of the Regulation allows for the use of salts of certain metals and of ammonium of authorised acids, alcohols and phenols, based on the conclusion that these salts will dissociate in the human stomach to the corresponding cations and the phenols, alcohols and acids (4). This Regulation requires that the four lanthanides should also be present in the dissociated ionic form. Therefore, in order to authorise their use as counter ions of already authorised acids, alcohols and phenols in all types of plastic materials and articles, and for the purpose of simplification, those four lanthanides should also be included in the scope of Article 6(3)(a). Therefore it is appropriate to amend this Article to include those four lanthanides. |
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(5)

Article 6(3)(a) of the Regulation allows for the use of salts of certain metals and of ammonium of authorised acids, alcohols and phenols, based on the conclusion that these salts will dissociate in the human stomach to the corresponding cations and the phenols, alcohols and acids (4). This Regulation requires that the four lanthanides should also be present in the dissociated ionic form. Therefore, in order to authorise their use as counter ions of already authorised acids, alcohols and phenols in all types of plastic materials and articles, and for the purpose of simplification, those four lanthanides should also be included in the scope of Article 6(3)(a). Therefore it is appropriate to amend this Article to include those four lanthanides.

| (6) | Article 10 of the Regulation sets out general restrictions related to plastic materials and articles, which are laid down in Annex II to the Regulation. Specifically, point 1 of this Annex restricts the migration of certain chemical elements from plastic materials and articles into food or food simulants. The chemical elements to which these limits apply may be present in plastic materials and Articles on the basis of several provisions set out in Chapter II of the Regulation. They may be present in the plastic because they are intentionally used as an additive or starting substance included in Annex I, or because their use is subject to a derogation under Article 6, including if they would be present in the plastic as an impurity or other non-intentionally added substance. The migration limits set in point 1 of Annex II to the Regulation therefore also apply to the metals which are present in the plastic material or article on the basis of Article 6(3)(a) of the Regulation. When the four lanthanides are added to the list of metals set out in Article 6(3)(a) their limits should therefore also be added to point 1 of Annex II. |
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(6)

Article 10 of the Regulation sets out general restrictions related to plastic materials and articles, which are laid down in Annex II to the Regulation. Specifically, point 1 of this Annex restricts the migration of certain chemical elements from plastic materials and articles into food or food simulants. The chemical elements to which these limits apply may be present in plastic materials and Articles on the basis of several provisions set out in Chapter II of the Regulation. They may be present in the plastic because they are intentionally used as an additive or starting substance included in Annex I, or because their use is subject to a derogation under Article 6, including if they would be present in the plastic as an impurity or other non-intentionally added substance. The migration limits set in point 1 of Annex II to the Regulation therefore also apply to the metals which are present in the plastic material or article on the basis of Article 6(3)(a) of the Regulation. When the four lanthanides are added to the list of metals set out in Article 6(3)(a) their limits should therefore also be added to point 1 of Annex II.

| (7) | The addition of the four lanthanides to Article 6(3)(a) further lengthens the list of substances set out in that provision. For reasons of clarity and good drafting practice such lists should not be set out in the enacting terms of the Regulation but in an Annex. As point 1 of Annex II already applies to most metals presently listed in Article 6(3)(a) this point can be used to also clarify whether it is permitted to use certain salts of these substances in accordance with Article 6(3)(a) without adding another list to the Regulation. It is therefore appropriate to clarify and simplify the Regulation by removing the names of the metals from Article 6(3)(a) and by amending Annex II to include them in point 1 of Annex II. For this purpose, it is appropriate to replace the present list of limits in point 1 of Annex II with a table that lists all metals presently included in Article 6(3)(a) and those included in point 1 of Annex II and with the specific conditions of use and migration limits of those metals. As Article 6(3)(a) also provides that ammonium salts of authorised acids, alcohols and phenols are authorised in the same way as the specified metals, it is appropriate that ammonium is also included in point 1 of Annex II. |
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(7)

The addition of the four lanthanides to Article 6(3)(a) further lengthens the list of substances set out in that provision. For reasons of clarity and good drafting practice such lists should not be set out in the enacting terms of the Regulation but in an Annex. As point 1 of Annex II already applies to most metals presently listed in Article 6(3)(a) this point can be used to also clarify whether it is permitted to use certain salts of these substances in accordance with Article 6(3)(a) without adding another list to the Regulation. It is therefore appropriate to clarify and simplify the Regulation by removing the names of the metals from Article 6(3)(a) and by amending Annex II to include them in point 1 of Annex II. For this purpose, it is appropriate to replace the present list of limits in point 1 of Annex II with a table that lists all metals presently included in Article 6(3)(a) and those included in point 1 of Annex II and with the specific conditions of use and migration limits of those metals. As Article 6(3)(a) also provides that ammonium salts of authorised acids, alcohols and phenols are authorised in the same way as the specified metals, it is appropriate that ammonium is also included in point 1 of Annex II.

| (8) | The substance 1,3 phenylenediamine (CAS No 0000108-45-2, FCM No 236) is a Primary Aromatic Amine currently included in Annex I of the Regulation to be used as a starting substance in plastic materials and articles intended to come into contact with food provided it does not migrate. However to verify compliance with this requirement it should not be detected in the food or the food simulant above the 0,01 mg/kg food or food simulant detection limit, in accordance with the second subparagraph of Article 11(4) of the Regulation. The advances in analytical capabilities allow the detection of 1,3 phenylenediamine at 0,002 mg/kg food or food simulant. It is therefore appropriate to amend Annex I of the Regulation to set this value as a specific detection limit for this substance to reflect this improvement in analytical capability and to maximise the health protection of consumers. |
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(8)

The substance 1,3 phenylenediamine (CAS No 0000108-45-2, FCM No 236) is a Primary Aromatic Amine currently included in Annex I of the Regulation to be used as a starting substance in plastic materials and articles intended to come into contact with food provided it does not migrate. However to verify compliance with this requirement it should not be detected in the food or the food simulant above the 0,01 mg/kg food or food simulant detection limit, in accordance with the second subparagraph of Article 11(4) of the Regulation. The advances in analytical capabilities allow the detection of 1,3 phenylenediamine at 0,002 mg/kg food or food simulant. It is therefore appropriate to amend Annex I of the Regulation to set this value as a specific detection limit for this substance to reflect this improvement in analytical capability and to maximise the health protection of consumers.

| (9) | The Authority adopted a favourable scientific opinion (5) on the use of the substance montmorillonite clay modified with hexadecyltrimethylammonium bromide (FCM No 1075), as an additive in plastic food contact materials. In that opinion, the Authority concluded that the substance is not of safety concern for the consumer if it is used as an additive at up to 4 % w/w in polylactic acid plastics intended for storage of water at ambient temperature or below. The Authority noted that once dispersed in the polylactic acid plastic, the particles can form platelets that can be in one or two dimensions in the nanoparticle range (< 100 nanometres). These platelets are not expected to migrate as they are oriented parallel to the plastic surface and they are fully embedded in the polymer. Therefore, that additive should be included in the Union list of authorised substances with the restriction that those specifications should be met. |
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(9)

The Authority adopted a favourable scientific opinion (5) on the use of the substance montmorillonite clay modified with hexadecyltrimethylammonium bromide (FCM No 1075), as an additive in plastic food contact materials. In that opinion, the Authority concluded that the substance is not of safety concern for the consumer if it is used as an additive at up to 4 % w/w in polylactic acid plastics intended for storage of water at ambient temperature or below. The Authority noted that once dispersed in the polylactic acid plastic, the particles can form platelets that can be in one or two dimensions in the nanoparticle range (< 100 nanometres). These platelets are not expected to migrate as they are oriented parallel to the plastic surface and they are fully embedded in the polymer. Therefore, that additive should be included in the Union list of authorised substances with the restriction that those specifications should be met.

| (10) | The Authority adopted a favourable scientific opinion (6) on the use of the substance phosphorous acid, triphenyl ester, polymer with alpha-hydro-omega-hydroxypoly[oxy(methyl-1,2-ethanediyl)], C10-16 alkyl esters (FCM No 1076 and CAS No 1227937-46-3), as an additive in plastic food contact materials. In that opinion, the Authority concluded that this substance is not of safety concern for the consumer if it is used as an additive at up to 0,2 % w/w in high impact polystyrene (‘HIPS’) materials and articles intended for contact with aqueous, acidic, low-alcohol and fatty foods, for long-term storage at room temperature and below, including hot-fill and/or heating up to 100 °C for up to 2 hours, and if its migration does not exceed 0,05 mg/kg food. To ensure that the migration levels established by the Authority are not exceeded, this substance should not be used in contact with foods for which food simulants C and/or D1 is assigned in Annex III to the Regulation. Therefore, that additive should be included in the Union list of authorised substances with the restriction that those specifications should be met. |
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(10)

The Authority adopted a favourable scientific opinion (6) on the use of the substance phosphorous acid, triphenyl ester, polymer with alpha-hydro-omega-hydroxypoly[oxy(methyl-1,2-ethanediyl)], C10-16 alkyl esters (FCM No 1076 and CAS No 1227937-46-3), as an additive in plastic food contact materials. In that opinion, the Authority concluded that this substance is not of safety concern for the consumer if it is used as an additive at up to 0,2 % w/w in high impact polystyrene (‘HIPS’) materials and articles intended for contact with aqueous, acidic, low-alcohol and fatty foods, for long-term storage at room temperature and below, including hot-fill and/or heating up to 100 °C for up to 2 hours, and if its migration does not exceed 0,05 mg/kg food. To ensure that the migration levels established by the Authority are not exceeded, this substance should not be used in contact with foods for which food simulants C and/or D1 is assigned in Annex III to the Regulation. Therefore, that additive should be included in the Union list of authorised substances with the restriction that those specifications should be met.

| (11) | The Authority adopted a favourable scientific opinion on the use of the substance titanium dioxide surface-treated with fluoride-modified alumina (FCM No 1077) as an additive in plastic food contact materials (7). In that opinion, the Authority noted that the substance, which is a defined mixture of particles of which a certain number have a diameter in the nanoparticle range (< 100 nanometres), is embedded in the polymer and does not migrate. The Authority concluded that this substance is not of safety concern to the consumer if it is used as an additive at up to 25,0 % w/w in all polymer types in contact with all food types for any time and temperature conditions. The Authority also concluded that the use of this substance in polar polymers which swell when in contact with foods for which food simulant B (3,0 % w/v acetic acid) is assigned in Annex III to the Regulation could exceed the respective specific migration limits of 0,15 mg/kg and 1,0 mg/kg food or food simulant for fluoride and aluminium respectively, if these polar polymers are used in certain contact conditions. Significant exceedance of those limits was shown in contact conditions exceeding 4 hours at 100 °C. This risk should be communicated to users of such materials and control authorities via a note on the verification of compliance. Therefore, it is appropriate to include this additive in the Union list of authorised substances, allowing its use as an additive at up to 25,0 % w/w and with a note on the verification of compliance, warning that the migration limits can be exceeded under certain conditions. |
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(11)

The Authority adopted a favourable scientific opinion on the use of the substance titanium dioxide surface-treated with fluoride-modified alumina (FCM No 1077) as an additive in plastic food contact materials (7). In that opinion, the Authority noted that the substance, which is a defined mixture of particles of which a certain number have a diameter in the nanoparticle range (< 100 nanometres), is embedded in the polymer and does not migrate. The Authority concluded that this substance is not of safety concern to the consumer if it is used as an additive at up to 25,0 % w/w in all polymer types in contact with all food types for any time and temperature conditions. The Authority also concluded that the use of this substance in polar polymers which swell when in contact with foods for which food simulant B (3,0 % w/v acetic acid) is assigned in Annex III to the Regulation could exceed the respective specific migration limits of 0,15 mg/kg and 1,0 mg/kg food or food simulant for fluoride and aluminium respectively, if these polar polymers are used in certain contact conditions. Significant exceedance of those limits was shown in contact conditions exceeding 4 hours at 100 °C. This risk should be communicated to users of such materials and control authorities via a note on the verification of compliance. Therefore, it is appropriate to include this additive in the Union list of authorised substances, allowing its use as an additive at up to 25,0 % w/w and with a note on the verification of compliance, warning that the migration limits can be exceeded under certain conditions.

| (12) | Antimony trioxide (CAS No 001309-64-4, FCM No 398) is currently included in Annex I of the Regulation to be used as an additive or polymer production aid in plastic materials and articles intended to come into contact with food, with a specific migration limit of 0,04 mg/kg food or food simulant established in the opinion (8) of the Authority on this substance adopted in 2004, expressed as antimony, and with a note on the verification of compliance in Table 3 of Annex I that this specific migration limit may be exceeded at very high temperature. Migration limit of 0,04 mg/kg is based on the Tolerable Daily Intake (‘TDI’) for antimony and a 10 % allocation factor to account for the contribution of exposure to antimony from sources other than plastic materials and articles intended to come into contact with foods. This migration limit together with the accompanying note on the verification of compliance should therefore apply for the migration of antimony from plastic materials and articles intended to come into contact with food. It is therefore appropriate that Annex II of the Regulation is amended to include antimony provided that its migration does not exceed 0,04 mg antimony/kg food or food simulant, and to also include the note on the verification of compliance of Table 3 of Annex I of that Regulation applicable to the antimony specific migration limit. |
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(12)

Antimony trioxide (CAS No 001309-64-4, FCM No 398) is currently included in Annex I of the Regulation to be used as an additive or polymer production aid in plastic materials and articles intended to come into contact with food, with a specific migration limit of 0,04 mg/kg food or food simulant established in the opinion (8) of the Authority on this substance adopted in 2004, expressed as antimony, and with a note on the verification of compliance in Table 3 of Annex I that this specific migration limit may be exceeded at very high temperature. Migration limit of 0,04 mg/kg is based on the Tolerable Daily Intake (‘TDI’) for antimony and a 10 % allocation factor to account for the contribution of exposure to antimony from sources other than plastic materials and articles intended to come into contact with foods. This migration limit together with the accompanying note on the verification of compliance should therefore apply for the migration of antimony from plastic materials and articles intended to come into contact with food. It is therefore appropriate that Annex II of the Regulation is amended to include antimony provided that its migration does not exceed 0,04 mg antimony/kg food or food simulant, and to also include the note on the verification of compliance of Table 3 of Annex I of that Regulation applicable to the antimony specific migration limit.

| (13) | The Authority has adopted opinions on arsenic (As), cadmium (Cd), chromium (Cr), lead (Pb), and mercury (Hg). These metals are not included in Annex I of the Regulation and therefore are not authorised to be used in plastic materials and articles intended to come into contact with food. The adverse health effects of these metals are well established and transfer of these metals from plastics materials and articles to food should not occur at levels harmful to human health. While the levels of these metals are normally brought under control during the subsequent manufacturing stages of plastic materials and articles in accordance with Article 4(d) of the Regulation, these metals can nevertheless end up being present as impurities in final plastic materials and articles based on the derogations set out in Article 6(4)(a), and adversely affect the health of the consumer. While the safety of these metals should principally be controlled in accordance with Article 19 of the Regulation and the documentation provided according to the provisions of Articles 15 and 16 of the Regulation, such work may not be implemented uniformly, and is burdensome and difficult to verify by competent authorities. Clearly defined migration limits based on opinions of the Authority would allow uniform analytical verification of compliance. It is therefore appropriate to amend Annex II of the Regulation to establish limits on the migration of these metals to ensure a uniform approach to verification of compliance, the application of a uniform level of health protection, and the proper functioning of the single market. |
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(13)

The Authority has adopted opinions on arsenic (As), cadmium (Cd), chromium (Cr), lead (Pb), and mercury (Hg). These metals are not included in Annex I of the Regulation and therefore are not authorised to be used in plastic materials and articles intended to come into contact with food. The adverse health effects of these metals are well established and transfer of these metals from plastics materials and articles to food should not occur at levels harmful to human health. While the levels of these metals are normally brought under control during the subsequent manufacturing stages of plastic materials and articles in accordance with Article 4(d) of the Regulation, these metals can nevertheless end up being present as impurities in final plastic materials and articles based on the derogations set out in Article 6(4)(a), and adversely affect the health of the consumer. While the safety of these metals should principally be controlled in accordance with Article 19 of the Regulation and the documentation provided according to the provisions of Articles 15 and 16 of the Regulation, such work may not be implemented uniformly, and is burdensome and difficult to verify by competent authorities. Clearly defined migration limits based on opinions of the Authority would allow uniform analytical verification of compliance. It is therefore appropriate to amend Annex II of the Regulation to establish limits on the migration of these metals to ensure a uniform approach to verification of compliance, the application of a uniform level of health protection, and the proper functioning of the single market.

| (14) | Some metals already exert adverse health effects at levels in the food below what can be quantified analytically using techniques applied by official control laboratories. In such a case, a method with a limit of detection in accordance with Article 11(4) of the Regulation is the appropriate means to verify the level of migration. The European Union Reference Laboratory for Food Contact Materials, designated in accordance with Regulation (EU) 2017/625 of the European Parliament and of the Council (9) (‘EURL-FCM’) has conducted work with the national reference laboratories which shows that analytical methods are already available that are suitable to detect the migration of metals from plastic materials at lower levels that is presently the case and which can be routinely used by the majority of involved laboratories. Even though some of these limits may change because of further analytical developments in the future, it is appropriate to assign the detection limits that can be achieved now to those metals in order to establish a maximum possible and uniform level of safety. Therefore it is appropriate to clarify the detection limits for metals in the list of limits in point 1 of Annex II to the Regulation, and to redraft that list as a table to provide a clearer framework for future changes to such limits. |
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(14)

Some metals already exert adverse health effects at levels in the food below what can be quantified analytically using techniques applied by official control laboratories. In such a case, a method with a limit of detection in accordance with Article 11(4) of the Regulation is the appropriate means to verify the level of migration. The European Union Reference Laboratory for Food Contact Materials, designated in accordance with Regulation (EU) 2017/625 of the European Parliament and of the Council (9) (‘EURL-FCM’) has conducted work with the national reference laboratories which shows that analytical methods are already available that are suitable to detect the migration of metals from plastic materials at lower levels that is presently the case and which can be routinely used by the majority of involved laboratories. Even though some of these limits may change because of further analytical developments in the future, it is appropriate to assign the detection limits that can be achieved now to those metals in order to establish a maximum possible and uniform level of safety. Therefore it is appropriate to clarify the detection limits for metals in the list of limits in point 1 of Annex II to the Regulation, and to redraft that list as a table to provide a clearer framework for future changes to such limits.

| (15) | Specifically, the Authority adopted an opinion on inorganic arsenic in food (10) in which it identified a range of benchmark dose (‘BMDL01’) values (at 99 % confidence limit) between 0,3 and 8 μg of arsenic/kg body weight per day for cancers of the lung, skin and bladder as well as skin lesions. The Authority further estimated that dietary exposures to inorganic arsenic for average and high level consumers are within the range of the BMDL01 values, and that there is little or no margin for any additional exposure, and therefore the possibility of a risk to some consumers cannot be excluded. Based on the lower BMDL01 value, on a 10 % allocation factor to account for the contribution of exposure to arsenic from sources other than plastic materials and articles intended to come into contact with food, and taking into account conventional exposure assumptions for food contact materials, the migration of arsenic from plastic materials and articles intended to come into contact with foods that may contain arsenic, should not exceed the level of 0,002 mg arsenic/kg food or food simulant. However, according to the EURL-FCM reliable detection of arsenic in food or food simulant has not been tested among National Reference Laboratories below the limit of detection as laid down in Article 11(4) to the Regulation. Therefore, it advised to retain the detection limit for arsenic of 0,01 mg/kg food instead. It is therefore appropriate to amend Annex II of the Regulation accordingly. |
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(15)

Specifically, the Authority adopted an opinion on inorganic arsenic in food (10) in which it identified a range of benchmark dose (‘BMDL01’) values (at 99 % confidence limit) between 0,3 and 8 μg of arsenic/kg body weight per day for cancers of the lung, skin and bladder as well as skin lesions. The Authority further estimated that dietary exposures to inorganic arsenic for average and high level consumers are within the range of the BMDL01 values, and that there is little or no margin for any additional exposure, and therefore the possibility of a risk to some consumers cannot be excluded. Based on the lower BMDL01 value, on a 10 % allocation factor to account for the contribution of exposure to arsenic from sources other than plastic materials and articles intended to come into contact with food, and taking into account conventional exposure assumptions for food contact materials, the migration of arsenic from plastic materials and articles intended to come into contact with foods that may contain arsenic, should not exceed the level of 0,002 mg arsenic/kg food or food simulant. However, according to the EURL-FCM reliable detection of arsenic in food or food simulant has not been tested among National Reference Laboratories below the limit of detection as laid down in Article 11(4) to the Regulation. Therefore, it advised to retain the detection limit for arsenic of 0,01 mg/kg food instead. It is therefore appropriate to amend Annex II of the Regulation accordingly.

| (16) | The Authority furthermore adopted an opinion on cadmium in food (11) in which it identified a Tolerable Weekly Intake (‘TWI’) of 2,5 μg of cadmium/kg body weight per week for kidney toxicity. In that opinion, the Authority also noted association of cadmium intakes with increased risk of cancers of the lung, endometrium, bladder and breast. The Authority estimated that the mean exposure for adults is close to, or slightly exceeding, the TWI and subgroups of consumers such as vegetarians, children, smokers and people living in highly contaminated areas may exceed the TWI by about twofold. The Authority concluded that although the risk for adverse effects on kidney function taking into account dietary exposures across Europe is very low, the current exposure to cadmium should be reduced. Based on the TWI, on a 10 % allocation factor to account for the contribution of exposure to cadmium from sources other than plastic materials and articles intended to come into contact with food, and taking into account conventional exposure assumptions for food contact materials, the migration of cadmium from plastic materials and articles intended to come into contact with food, should not exceed the level of 0,002 mg/kg in food or food simulant. Therefore, cadmium should not be detected in the food or the food simulant above the 0,002 mg/kg food or food simulant. It is therefore appropriate to amend Annex II of the Regulation accordingly. |
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(16)

The Authority furthermore adopted an opinion on cadmium in food (11) in which it identified a Tolerable Weekly Intake (‘TWI’) of 2,5 μg of cadmium/kg body weight per week for kidney toxicity. In that opinion, the Authority also noted association of cadmium intakes with increased risk of cancers of the lung, endometrium, bladder and breast. The Authority estimated that the mean exposure for adults is close to, or slightly exceeding, the TWI and subgroups of consumers such as vegetarians, children, smokers and people living in highly contaminated areas may exceed the TWI by about twofold. The Authority concluded that although the risk for adverse effects on kidney function taking into account dietary exposures across Europe is very low, the current exposure to cadmium should be reduced. Based on the TWI, on a 10 % allocation factor to account for the contribution of exposure to cadmium from sources other than plastic materials and articles intended to come into contact with food, and taking into account conventional exposure assumptions for food contact materials, the migration of cadmium from plastic materials and articles intended to come into contact with food, should not exceed the level of 0,002 mg/kg in food or food simulant. Therefore, cadmium should not be detected in the food or the food simulant above the 0,002 mg/kg food or food simulant. It is therefore appropriate to amend Annex II of the Regulation accordingly.

| (17) | The Authority also adopted an opinion on the risks to public health related to the presence of chromium in food and drinking water (12). In this opinion, the Authority acknowledged that there is a lack of data on the presence of hexavalent chromium in food and decided to consider that essentially all of chromium analytically identified in food is likely to be trivalent chromium as food is, largely, a reducing medium that would not favour oxidation of trivalent chromium to hexavalent chromium. The Authority added however that, even if a small proportion of the total chromium in food is in the more toxic hexavalent form, it could contribute substantially to hexavalent chromium exposure. Hexavalent chromium can be present in drinking water including bottled drinking water. Although the more advanced available analytical techniques can distinguish between the trivalent and hexavalent chromium species, this species analytical differentiation can be cumbersome and difficult for competent authorities and business operators. It is therefore appropriate to take into account these considerations when ensuring compliance of plastic materials and articles, intended to come into contact with food that may contain chromium, with the Regulation. |
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(17)

The Authority also adopted an opinion on the risks to public health related to the presence of chromium in food and drinking water (12). In this opinion, the Authority acknowledged that there is a lack of data on the presence of hexavalent chromium in food and decided to consider that essentially all of chromium analytically identified in food is likely to be trivalent chromium as food is, largely, a reducing medium that would not favour oxidation of trivalent chromium to hexavalent chromium. The Authority added however that, even if a small proportion of the total chromium in food is in the more toxic hexavalent form, it could contribute substantially to hexavalent chromium exposure. Hexavalent chromium can be present in drinking water including bottled drinking water. Although the more advanced available analytical techniques can distinguish between the trivalent and hexavalent chromium species, this species analytical differentiation can be cumbersome and difficult for competent authorities and business operators. It is therefore appropriate to take into account these considerations when ensuring compliance of plastic materials and articles, intended to come into contact with food that may contain chromium, with the Regulation.

| (18) | The Authority established a TDI of 0,3 mg/kg body weight per day for trivalent chromium for diffuse duodenal epithelial hyperplasia and haematotoxicity. The Authority estimated that the dietary intakes of trivalent chromium for average and high level consumers in Europe amount to 5 and 8 % of the TDI respectively. Based on the TDI and on a 20 % allocation factor to account for the contribution of exposure to chromium from sources other than plastic materials and articles intended to come into contact with food and taking into account conventional exposure assumptions for food contact materials, a specific migration limit of 3,6 mg trivalent chromium/kg food or food simulant is appropriate. It is therefore appropriate to amend Annex II of the Regulation to include trivalent chromium provided that the migration from plastic materials and articles intended to come into contact with food does not exceed 3,6 mg trivalent chromium/kg food or food simulant. |
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(18)

The Authority established a TDI of 0,3 mg/kg body weight per day for trivalent chromium for diffuse duodenal epithelial hyperplasia and haematotoxicity. The Authority estimated that the dietary intakes of trivalent chromium for average and high level consumers in Europe amount to 5 and 8 % of the TDI respectively. Based on the TDI and on a 20 % allocation factor to account for the contribution of exposure to chromium from sources other than plastic materials and articles intended to come into contact with food and taking into account conventional exposure assumptions for food contact materials, a specific migration limit of 3,6 mg trivalent chromium/kg food or food simulant is appropriate. It is therefore appropriate to amend Annex II of the Regulation to include trivalent chromium provided that the migration from plastic materials and articles intended to come into contact with food does not exceed 3,6 mg trivalent chromium/kg food or food simulant.

| (19) | In addition, the Authority also established a benchmark dose (at 90 % confidence limit) (‘BMDL10’) of 1,0 mg/kg body weight per day for hexavalent chromium. Since this species of chromium is genotoxic and carcinogenic, the Authority considered that a Margin of Exposure (‘MOE’) above 10 000 is required for the exposure to be of low concern. Taking into account the BMDL10, the minimum MOE of 10 000, a 20 % allocation to account for the contribution of exposure to hexavalent chromium from sources other than plastic materials and articles intended to come into contact with food, and taking into account conventional exposure assumptions for food contact materials, the migration of hexavalent chromium from plastic materials and articles intended to come into contact with foods should not exceed the level of 0,0012 mg hexavalent chromium/kg food or food simulant to exclude adverse health effects. However, according to the EURL-FCM reliable detection of total chromium in food or food simulant has not been tested among National Reference Laboratories below the limit of detection as laid down in Article 11(4) to the Regulation. Therefore it advised to retain the detection limit for chromium of 0,01 mg/kg food instead. |
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(19)

In addition, the Authority also established a benchmark dose (at 90 % confidence limit) (‘BMDL10’) of 1,0 mg/kg body weight per day for hexavalent chromium. Since this species of chromium is genotoxic and carcinogenic, the Authority considered that a Margin of Exposure (‘MOE’) above 10 000 is required for the exposure to be of low concern. Taking into account the BMDL10, the minimum MOE of 10 000, a 20 % allocation to account for the contribution of exposure to hexavalent chromium from sources other than plastic materials and articles intended to come into contact with food, and taking into account conventional exposure assumptions for food contact materials, the migration of hexavalent chromium from plastic materials and articles intended to come into contact with foods should not exceed the level of 0,0012 mg hexavalent chromium/kg food or food simulant to exclude adverse health effects. However, according to the EURL-FCM reliable detection of total chromium in food or food simulant has not been tested among National Reference Laboratories below the limit of detection as laid down in Article 11(4) to the Regulation. Therefore it advised to retain the detection limit for chromium of 0,01 mg/kg food instead.

| (20) | There is a large difference in toxicity between trivalent and hexavalent chromium and it is difficult to distinguish between the two chromium species without using burdensome analytical methods. Therefore, verifying compliance with the Regulation of plastic materials and articles that may contain chromium should be done on the basis of hexavalent Chromium as this is the most toxic species. Annex II of the Regulation should therefore be amended to include the detection limit as the limit for chromium migration into food or food simulant. The migration of all chromium, regardless of its oxidation state, from plastic materials and articles intended to come into contact with foods, should therefore not be detectable in food or food simulant above the level of 0,01 mg/kg food or food simulant. However, if the business operator placing the material on the market can prove on the basis of pre-existing documentary evidence that the presence of hexavalent chromium in the material can be excluded because it is not used or formed during the entire production process, the migrating species should be considered trivalent chromium only and therefore a migration limit of 3,6 mg/kg food should apply in accordance with the second subparagraph of Article 11(4) of the Regulation. It is therefore appropriate to amend Annex II to the Regulation. |
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(20)

There is a large difference in toxicity between trivalent and hexavalent chromium and it is difficult to distinguish between the two chromium species without using burdensome analytical methods. Therefore, verifying compliance with the Regulation of plastic materials and articles that may contain chromium should be done on the basis of hexavalent Chromium as this is the most toxic species. Annex II of the Regulation should therefore be amended to include the detection limit as the limit for chromium migration into food or food simulant. The migration of all chromium, regardless of its oxidation state, from plastic materials and articles intended to come into contact with foods, should therefore not be detectable in food or food simulant above the level of 0,01 mg/kg food or food simulant. However, if the business operator placing the material on the market can prove on the basis of pre-existing documentary evidence that the presence of hexavalent chromium in the material can be excluded because it is not used or formed during the entire production process, the migrating species should be considered trivalent chromium only and therefore a migration limit of 3,6 mg/kg food should apply in accordance with the second subparagraph of Article 11(4) of the Regulation. It is therefore appropriate to amend Annex II to the Regulation.

| (21) | The Authority adopted an opinion on the risks to public health related to the presence of lead in food (13). It determined the 95th percentile lower confidence limit of the benchmark dose (BMD) of 1 % extra risk (BMDL01) of 0,5 μg lead/kg body weight as a reference point for the risk characterisation of lead when assessing the risk of intellectual deficits in children measured by the Full Scale IQ score. A 1 % increase of systolic blood pressure (SBP) annually or on average in the whole population was considered a public health issue. On this basis the Authority calculated a mean BMDL01 for SBP of 36 μg/L, corresponding to 1,5 μg lead/kg body weight per day for effects on systolic blood pressure. It also calculated a BMDL10 value (at 90 % confidence limit) of 0,63 μg lead/kg body weight per day for effects on prevalence of chronic kidney disease. The Authority concluded that in adults, children, and infants, the margins of exposure were such that the possibility of an effect from lead in some consumers, particularly in children, cannot be excluded at any level of exposure, and a health based guidance value could therefore not be derived. The Authority also concluded that protection of children against the potential risk of neurodevelopmental effects would be protective for all other adverse effects of lead, in all populations. |
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(21)

The Authority adopted an opinion on the risks to public health related to the presence of lead in food (13). It determined the 95th percentile lower confidence limit of the benchmark dose (BMD) of 1 % extra risk (BMDL01) of 0,5 μg lead/kg body weight as a reference point for the risk characterisation of lead when assessing the risk of intellectual deficits in children measured by the Full Scale IQ score. A 1 % increase of systolic blood pressure (SBP) annually or on average in the whole population was considered a public health issue. On this basis the Authority calculated a mean BMDL01 for SBP of 36 μg/L, corresponding to 1,5 μg lead/kg body weight per day for effects on systolic blood pressure. It also calculated a BMDL10 value (at 90 % confidence limit) of 0,63 μg lead/kg body weight per day for effects on prevalence of chronic kidney disease. The Authority concluded that in adults, children, and infants, the margins of exposure were such that the possibility of an effect from lead in some consumers, particularly in children, cannot be excluded at any level of exposure, and a health based guidance value could therefore not be derived. The Authority also concluded that protection of children against the potential risk of neurodevelopmental effects would be protective for all other adverse effects of lead, in all populations.

| (22) | Lead should not be used intentionally to manufacture a plastic material, but it can be present as an impurity. As its presence cannot be fully prevented, and it can cause health effects at any level of exposure, there should be uniform rules to ensure its presence can be controlled. It is therefore appropriate to establish a common limit for its migration from plastic materials. In absence of a health based guidance value the BMDL01 value of 0,5 μg lead/kg body weight per day is used as basis for that limit. Lead exposure however occurs from many sources other than from articles and materials intended to come into contact with food. To derive a limit for the migration of lead from plastic materials and articles intended to come into contact with food, it is therefore appropriate to apply a conventional allocation factor of 10 %, to account for the contribution of lead from materials and articles intended to come into contact with food to the total lead exposure. Taking into account conventional exposure assumptions for such materials and articles, and assuming an average body weight of 60 kg, the migration of lead from plastic materials and articles intended to come into contact with food should not exceed 0,003 mg/kg food in food or food simulant in order to reduce the probability of adverse health effects to a minimum. However, according to the EURL-FCM reliable detection of lead in food or food simulant has not been tested among National Reference Laboratories below the limit of detection as laid down in Article 11(4) to the Regulation. Therefore, it advised to assign a detection limit for lead at 0,01 mg/kg food instead. It is therefore appropriate to amend Annex II of the Regulation accordingly. |
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(22)

Lead should not be used intentionally to manufacture a plastic material, but it can be present as an impurity. As its presence cannot be fully prevented, and it can cause health effects at any level of exposure, there should be uniform rules to ensure its presence can be controlled. It is therefore appropriate to establish a common limit for its migration from plastic materials. In absence of a health based guidance value the BMDL01 value of 0,5 μg lead/kg body weight per day is used as basis for that limit. Lead exposure however occurs from many sources other than from articles and materials intended to come into contact with food. To derive a limit for the migration of lead from plastic materials and articles intended to come into contact with food, it is therefore appropriate to apply a conventional allocation factor of 10 %, to account for the contribution of lead from materials and articles intended to come into contact with food to the total lead exposure. Taking into account conventional exposure assumptions for such materials and articles, and assuming an average body weight of 60 kg, the migration of lead from plastic materials and articles intended to come into contact with food should not exceed 0,003 mg/kg food in food or food simulant in order to reduce the probability of adverse health effects to a minimum. However, according to the EURL-FCM reliable detection of lead in food or food simulant has not been tested among National Reference Laboratories below the limit of detection as laid down in Article 11(4) to the Regulation. Therefore, it advised to assign a detection limit for lead at 0,01 mg/kg food instead. It is therefore appropriate to amend Annex II of the Regulation accordingly.

| (23) | The Authority adopted an opinion on the risks to public health related to the presence of mercury and methyl mercury in food (14) in which it identified a TWI of 4,0 μg of inorganic mercury (expressed as elemental mercury)/kg body weight for kidney toxicity. The Authority concluded that the estimated exposure to inorganic mercury in Europe from the diet alone does not exceed the TWI. Based on the TWI, on a 20 % allocation factor to account for the contribution of exposure to mercury from sources other than plastic materials and articles intended to come into contact with food, and taking into account conventional exposure assumptions for food contact materials, the migration of mercury from plastic materials and articles intended to come into contact with food, should not exceed the level of 0,007 mg/kg food or food simulant. However, according to the EURL-FCM reliable detection of mercury in food or food simulant has not been tested among National Reference Laboratories below the limit of detection as laid down in Article 11(4) to the Regulation. Therefore, it advised to retain the detection limit for mercury of 0,01 mg/kg food instead. It is therefore appropriate to amend Annex II of the Regulation accordingly. |
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(23)

The Authority adopted an opinion on the risks to public health related to the presence of mercury and methyl mercury in food (14) in which it identified a TWI of 4,0 μg of inorganic mercury (expressed as elemental mercury)/kg body weight for kidney toxicity. The Authority concluded that the estimated exposure to inorganic mercury in Europe from the diet alone does not exceed the TWI. Based on the TWI, on a 20 % allocation factor to account for the contribution of exposure to mercury from sources other than plastic materials and articles intended to come into contact with food, and taking into account conventional exposure assumptions for food contact materials, the migration of mercury from plastic materials and articles intended to come into contact with food, should not exceed the level of 0,007 mg/kg food or food simulant. However, according to the EURL-FCM reliable detection of mercury in food or food simulant has not been tested among National Reference Laboratories below the limit of detection as laid down in Article 11(4) to the Regulation. Therefore, it advised to retain the detection limit for mercury of 0,01 mg/kg food instead. It is therefore appropriate to amend Annex II of the Regulation accordingly.

| (24) | Primary aromatic amines (‘PAAs’) may be used in plastic food contact materials as colorants or may be present as not intentionally added substances in accordance with Article 6 of the Regulation. PAAs are a large family of compounds, some of which are carcinogens, while others are suspected carcinogens. Certain PAAs may have adverse effects at any migration level, therefore they should not migrate into the food. However, it is not possible to exclude their migration analytically, as analytical methods can only exclude migration above their limit of detection. For the purpose of compliance verification, and to ensure legal certainty, the migration of PAAs into food has been restricted to a specified level that is not detectable in the food or food simulant by means of commonly used analytical methods. However, according to the EURL-FCM advances in analytical capabilities ensure that equipment is now commonly available that allows to lower the detection limit of 0,01 mg/kg food or food simulant that the Regulation presently assigns to the detection of individual PAAs to a new detection limit of 0,002 mg/kg food or food simulant. Therefore that lower detection limit should be defined in the Regulation as the detection limit for individual PAAs. |
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(24)

Primary aromatic amines (‘PAAs’) may be used in plastic food contact materials as colorants or may be present as not intentionally added substances in accordance with Article 6 of the Regulation. PAAs are a large family of compounds, some of which are carcinogens, while others are suspected carcinogens. Certain PAAs may have adverse effects at any migration level, therefore they should not migrate into the food. However, it is not possible to exclude their migration analytically, as analytical methods can only exclude migration above their limit of detection. For the purpose of compliance verification, and to ensure legal certainty, the migration of PAAs into food has been restricted to a specified level that is not detectable in the food or food simulant by means of commonly used analytical methods. However, according to the EURL-FCM advances in analytical capabilities ensure that equipment is now commonly available that allows to lower the detection limit of 0,01 mg/kg food or food simulant that the Regulation presently assigns to the detection of individual PAAs to a new detection limit of 0,002 mg/kg food or food simulant. Therefore that lower detection limit should be defined in the Regulation as the detection limit for individual PAAs.

| (25) | At present, the restriction on PAAs in Annex II applies to all PAAs that are not listed in Table 1 of Annex I to the Regulation. Applying the new low detection limit that this Regulation now assigns would require testing for a large number of substances, and, not all PAAs would adversely affect health above that detection limit. The most problematic PAAs are listed in entry 43 of Appendix 8 to Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council (15), ‘the Azocolourants entry’. It is therefore appropriate to apply the new detection limit only to these substances, given their established toxicity. Other PAAs for which no limit is laid down in Annex I should be assessed in accordance with Article 19 of the Regulation. However, to avoid their combined toxicity may cause adverse health problems, it is appropriate to limit their total migration to a maximum of 0,01 mg/kg food or food simulant. |
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(25)

At present, the restriction on PAAs in Annex II applies to all PAAs that are not listed in Table 1 of Annex I to the Regulation. Applying the new low detection limit that this Regulation now assigns would require testing for a large number of substances, and, not all PAAs would adversely affect health above that detection limit. The most problematic PAAs are listed in entry 43 of Appendix 8 to Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council (15), ‘the Azocolourants entry’. It is therefore appropriate to apply the new detection limit only to these substances, given their established toxicity. Other PAAs for which no limit is laid down in Annex I should be assessed in accordance with Article 19 of the Regulation. However, to avoid their combined toxicity may cause adverse health problems, it is appropriate to limit their total migration to a maximum of 0,01 mg/kg food or food simulant.

| (26) | Point 2 of Annex II to the Regulation requires that the sum of PAAs does not exceed 0,01 mg/kg food or food simulant, to avoid that their collective presence can cause adverse health effects. As the limit of detection is now lowered to 0,002 mg/kg food or food simulant for all PAAs listed in the Azocolourants entry, the sum would not require evaluation if such a PAA is detected because the material would not be in compliance with the Regulation anyway in this case. However, when it is known or suspected that certain PAAs not listed in Annex I or in the Azocolourants entry may be present, their presence can be assessed on the basis of migration testing and modelling considerations. Therefore, it is appropriate to maintain the provision that the sum of those PAAs does not exceed 0,01 mg/kg food or food simulant. |
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(26)

Point 2 of Annex II to the Regulation requires that the sum of PAAs does not exceed 0,01 mg/kg food or food simulant, to avoid that their collective presence can cause adverse health effects. As the limit of detection is now lowered to 0,002 mg/kg food or food simulant for all PAAs listed in the Azocolourants entry, the sum would not require evaluation if such a PAA is detected because the material would not be in compliance with the Regulation anyway in this case. However, when it is known or suspected that certain PAAs not listed in Annex I or in the Azocolourants entry may be present, their presence can be assessed on the basis of migration testing and modelling considerations. Therefore, it is appropriate to maintain the provision that the sum of those PAAs does not exceed 0,01 mg/kg food or food simulant.

| (27) | The new or updated restrictions on substances in Annex II require clear communication in the supply chain to ensure that adequate information on the presence of these substances is available to business operators which use products from intermediate stages in the supply chain or final articles or materials in which these substances may be contained. When such information is not provided they cannot be certain on the presence and amount of these substances and they would need to test more frequently than would be needed if that information was provided. However, if the presence and amount of these substances is known to these business operators, in many cases simple calculation techniques can suffice to establish whether a limit could be exceeded, and analytical testing would not be required at all. Moreover, communication of the amounts of substances is also required to communicate on the presence of these substances to later stages of the supply chain. Therefore, it is appropriate to amend point 6 of Annex IV to the Regulation to clarify that the amount of substances subject to limits under Annex II should be included in the declaration of compliance. |
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(27)

The new or updated restrictions on substances in Annex II require clear communication in the supply chain to ensure that adequate information on the presence of these substances is available to business operators which use products from intermediate stages in the supply chain or final articles or materials in which these substances may be contained. When such information is not provided they cannot be certain on the presence and amount of these substances and they would need to test more frequently than would be needed if that information was provided. However, if the presence and amount of these substances is known to these business operators, in many cases simple calculation techniques can suffice to establish whether a limit could be exceeded, and analytical testing would not be required at all. Moreover, communication of the amounts of substances is also required to communicate on the presence of these substances to later stages of the supply chain. Therefore, it is appropriate to amend point 6 of Annex IV to the Regulation to clarify that the amount of substances subject to limits under Annex II should be included in the declaration of compliance.

| (28) | Before placing an intermediate or final product on the market, the manufacturer of that product needs to assess whether it complies with Article 3 of Regulation (EC) No 1935/2004, and/or complies with Article 19 of the Regulation. Various and complementary approaches should be used in such assessment. A common and cost efficient testing approach is to determine only the safety of substances that are present above a concentration of 10 ppb by using migration testing with a food simulant. Substances that do not exceed this limit are then considered safe. However, the migration of substances at a level of 10 ppb can only be considered safe provided that their genotoxicity can be ruled out. Therefore, the use of such a testing technique should always be complemented by an assessment of whether substances that could be genotoxic are present. Therefore, it should be communicated to downstream users of an intermediate or final material that it may contain substances of which the genotoxicity has not been ruled out. Producers of intermediate materials know that these substances can be present in their products as they use preparations that contain them, or should obtain that information from their suppliers. Therefore, point 6 of Annex IV should also be clarified to require information on substances present in a material or article, of which genotoxicity has not been ruled out. |
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(28)

Before placing an intermediate or final product on the market, the manufacturer of that product needs to assess whether it complies with Article 3 of Regulation (EC) No 1935/2004, and/or complies with Article 19 of the Regulation. Various and complementary approaches should be used in such assessment. A common and cost efficient testing approach is to determine only the safety of substances that are present above a concentration of 10 ppb by using migration testing with a food simulant. Substances that do not exceed this limit are then considered safe. However, the migration of substances at a level of 10 ppb can only be considered safe provided that their genotoxicity can be ruled out. Therefore, the use of such a testing technique should always be complemented by an assessment of whether substances that could be genotoxic are present. Therefore, it should be communicated to downstream users of an intermediate or final material that it may contain substances of which the genotoxicity has not been ruled out. Producers of intermediate materials know that these substances can be present in their products as they use preparations that contain them, or should obtain that information from their suppliers. Therefore, point 6 of Annex IV should also be clarified to require information on substances present in a material or article, of which genotoxicity has not been ruled out.

| (29) | Point 2.1.6 of Annex V to the Regulation requires three subsequent tests for articles and materials that are placed in repeated contact with food. The results of the third migration test should be used to verify compliance with the migration limits. However, if the migration was to increase between the first, second and third test, the tests would not be suitable to verify compliance even in cases where the specific migration limit is not exceeded in any of the three tests, as they will not adequately predict the final migration level after continued contact with food. Thereto the migration should be strictly decreasing in subsequent tests. While this principle is already reflected in the second subparagraph of point 2.1.6 on conditions to use the results of the first test, as well as in point 3.3.2 on overall migration testing, a requirement that the migration should not increase between subsequent tests was not specified in the first paragraph of point 2.1.6. It would therefore be appropriate to amend the Regulation and add this requirement. However, in some instances, such as when migration is low relative to the measurement error, it may be difficult to establish a decreasing trend analytically and it would require complex rules. Therefore it is appropriate to only require that a the migration established in a subsequent test does not exceed that of the previous test, to clarify this principle in the Regulation, and to establish that a material that shows increasing migration over the subsequent tests should never be considered compliant. |
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(29)

Point 2.1.6 of Annex V to the Regulation requires three subsequent tests for articles and materials that are placed in repeated contact with food. The results of the third migration test should be used to verify compliance with the migration limits. However, if the migration was to increase between the first, second and third test, the tests would not be suitable to verify compliance even in cases where the specific migration limit is not exceeded in any of the three tests, as they will not adequately predict the final migration level after continued contact with food. Thereto the migration should be strictly decreasing in subsequent tests. While this principle is already reflected in the second subparagraph of point 2.1.6 on conditions to use the results of the first test, as well as in point 3.3.2 on overall migration testing, a requirement that the migration should not increase between subsequent tests was not specified in the first paragraph of point 2.1.6. It would therefore be appropriate to amend the Regulation and add this requirement. However, in some instances, such as when migration is low relative to the measurement error, it may be difficult to establish a decreasing trend analytically and it would require complex rules. Therefore it is appropriate to only require that a the migration established in a subsequent test does not exceed that of the previous test, to clarify this principle in the Regulation, and to establish that a material that shows increasing migration over the subsequent tests should never be considered compliant.

| (30) | Annex V provides rules for the tests to demonstrate the compliance of migration from plastic materials and articles intended to come into contact with food with the migration limits referred to in Articles 11 and 12 of the Regulation. Certain types of plastic materials and articles are intended to come to contact with food only at cold or ambient temperatures and for a short duration (less than 30 minutes). While conditions for the specific migration testing for such intended contact are available, corresponding conditions for the overall migration testing are not assigned in Table 3 of Annex V of the Regulation. The Overall Migration (OM) testing condition 2 (OM2), which requires testing at 40 °C for 10 days, and the OM3, which requires testing at 70 °C for two hours, are the two OM test conditions which come close in simulating the intended food contact conditions for these types of kitchenware but they are significantly more severe than the real life conditions which could foreseeably occur during actual use of such kitchenware. Therefore it is appropriate to amend Table 3 of Annex V of the Regulation and the relevant text below that table to introduce overall migration conditions of 30 minutes at 40 °C designated as OM0 for the overall migration testing of plastic kitchenware materials and articles only at cold or ambient temperatures and for a short duration. |
| --- | --- |

(30)

Annex V provides rules for the tests to demonstrate the compliance of migration from plastic materials and articles intended to come into contact with food with the migration limits referred to in Articles 11 and 12 of the Regulation. Certain types of plastic materials and articles are intended to come to contact with food only at cold or ambient temperatures and for a short duration (less than 30 minutes). While conditions for the specific migration testing for such intended contact are available, corresponding conditions for the overall migration testing are not assigned in Table 3 of Annex V of the Regulation. The Overall Migration (OM) testing condition 2 (OM2), which requires testing at 40 °C for 10 days, and the OM3, which requires testing at 70 °C for two hours, are the two OM test conditions which come close in simulating the intended food contact conditions for these types of kitchenware but they are significantly more severe than the real life conditions which could foreseeably occur during actual use of such kitchenware. Therefore it is appropriate to amend Table 3 of Annex V of the Regulation and the relevant text below that table to introduce overall migration conditions of 30 minutes at 40 °C designated as OM0 for the overall migration testing of plastic kitchenware materials and articles only at cold or ambient temperatures and for a short duration.

| (31) | Migration testing at 100 °C can be technically difficult in some situations because of high evaporation of water. In order to overcome this difficulty and to ensure that migration testing can be properly conducted, a reflux condition may be used as an alternative to test for specific and overall migration at 100 °C. Such a reflux condition is provided for as an option in the OM5 and OM6 test conditions in Table 3 of Annex V of the Regulation which require testing at 100 °C. A reflux alternative testing condition is not provided for the OM4 test condition which also requires testing at 100 °C. It is therefore appropriate to amend the OM4 entry in Table 3 of Annex V of the Regulation to provide for the reflux condition as an option when testing at 100 °C is technically difficult. |
| --- | --- |

(31)

Migration testing at 100 °C can be technically difficult in some situations because of high evaporation of water. In order to overcome this difficulty and to ensure that migration testing can be properly conducted, a reflux condition may be used as an alternative to test for specific and overall migration at 100 °C. Such a reflux condition is provided for as an option in the OM5 and OM6 test conditions in Table 3 of Annex V of the Regulation which require testing at 100 °C. A reflux alternative testing condition is not provided for the OM4 test condition which also requires testing at 100 °C. It is therefore appropriate to amend the OM4 entry in Table 3 of Annex V of the Regulation to provide for the reflux condition as an option when testing at 100 °C is technically difficult.

| (32) | Migration testing using the whole equipment or appliance for food processing and/or food production is presently not allowed under the Regulation. However, when food processing equipment or appliances are made of multiple plastic parts, or contain plastic parts as well as other materials, it may be burdensome and in some cases impossible to verify compliance of these plastic parts with the Regulation. It should therefore be possible to verify compliance by conducting migration tests in the food or food simulant produced or processed using the whole equipment or appliance, or assemblies or modules thereof, in accordance with the operating instructions, instead of trying to establish the migration from each individual plastic part or material used in the equipment or appliance. If such a migration test is done under the worst foreseeable use conditions in the food, or when appropriate, in a food simulant, which can be achieved in accordance with the operating instructions, and the transfer of constituents from the equipment or appliance as a whole does not exceed the specific migration limits, the plastic parts of the food processing equipment should be considered to comply with the requirements of Article 11(1) of the Regulation if the plastic parts comply with the compositional provisions set out in the Regulation. It is therefore appropriate to amend Annex V of the Regulation to introduce provisions that will allow for the migration testing with the whole equipment or appliance for food processing and/or food production, instead of verifying the compliance of each of its individual parts. |
| --- | --- |

(32)

Migration testing using the whole equipment or appliance for food processing and/or food production is presently not allowed under the Regulation. However, when food processing equipment or appliances are made of multiple plastic parts, or contain plastic parts as well as other materials, it may be burdensome and in some cases impossible to verify compliance of these plastic parts with the Regulation. It should therefore be possible to verify compliance by conducting migration tests in the food or food simulant produced or processed using the whole equipment or appliance, or assemblies or modules thereof, in accordance with the operating instructions, instead of trying to establish the migration from each individual plastic part or material used in the equipment or appliance. If such a migration test is done under the worst foreseeable use conditions in the food, or when appropriate, in a food simulant, which can be achieved in accordance with the operating instructions, and the transfer of constituents from the equipment or appliance as a whole does not exceed the specific migration limits, the plastic parts of the food processing equipment should be considered to comply with the requirements of Article 11(1) of the Regulation if the plastic parts comply with the compositional provisions set out in the Regulation. It is therefore appropriate to amend Annex V of the Regulation to introduce provisions that will allow for the migration testing with the whole equipment or appliance for food processing and/or food production, instead of verifying the compliance of each of its individual parts.

| (33) | Applying the whole equipment or appliance in accordance with its operating instructions to prepare the food, or parts thereof may not be representative for all of its parts. Certain parts will be subject to different contact conditions, in particular those parts that are used for storage, in some cases long term, such as containers, reservoirs, capsules, and pads. Those parts would need to be tested also separately to ensure they are safe for those storage conditions as well. |
| --- | --- |

(33)

Applying the whole equipment or appliance in accordance with its operating instructions to prepare the food, or parts thereof may not be representative for all of its parts. Certain parts will be subject to different contact conditions, in particular those parts that are used for storage, in some cases long term, such as containers, reservoirs, capsules, and pads. Those parts would need to be tested also separately to ensure they are safe for those storage conditions as well.

| (34) | Migration testing of food processing and/or food producing equipment or appliance can only establish the compliance of the equipment with the Regulation. However, in case a non-compliant migration is observed when testing food processing and/or food producing equipment or appliances, it should be verified that this migration does not originate from materials not subject to the Regulation. Therefore, it is appropriate to require to establish whether the source of the non-compliance is a plastic part of the equipment or appliance, or whether it is another material not subject to the Regulation. The non-compliance of the equipment with the Regulation should then only be established if that non-compliance is due to a plastic part. |
| --- | --- |

(34)

Migration testing of food processing and/or food producing equipment or appliance can only establish the compliance of the equipment with the Regulation. However, in case a non-compliant migration is observed when testing food processing and/or food producing equipment or appliances, it should be verified that this migration does not originate from materials not subject to the Regulation. Therefore, it is appropriate to require to establish whether the source of the non-compliance is a plastic part of the equipment or appliance, or whether it is another material not subject to the Regulation. The non-compliance of the equipment with the Regulation should then only be established if that non-compliance is due to a plastic part.

| (35) | The first paragraph of Chapter 3.2 of Annex V of the Regulation sets out conditions for the substitution of food simulant D2 with 95 % ethanol and isooctane in the overall migration (OM) tests 1-6 referred to in Table 3 of Annex V, when it is not technically feasible to perform one or more of the OM tests 1-6 with the simulant D2. The third sentence of that paragraph erroneously makes reference to specific migration rather than to overall migration. It is therefore necessary to correct that sentence. |
| --- | --- |

(35)

The first paragraph of Chapter 3.2 of Annex V of the Regulation sets out conditions for the substitution of food simulant D2 with 95 % ethanol and isooctane in the overall migration (OM) tests 1-6 referred to in Table 3 of Annex V, when it is not technically feasible to perform one or more of the OM tests 1-6 with the simulant D2. The third sentence of that paragraph erroneously makes reference to specific migration rather than to overall migration. It is therefore necessary to correct that sentence.

| (36) | The second paragraph of Chapter 3.2 of Annex V of the Regulation sets out conditions for the substitution of the overall migration (OM) test 7 with the OM tests 8 or 9 when it is not technically feasible to perform the OM test 7 with simulant D2. The wording of that paragraph does not clearly specify by which test OM 7 should be substituted, and makes reference to the highest overall migration in the last sentence, which could be erroneously interpreted in such a way that more than two OM tests should be conducted. It is therefore appropriate to clarify the paragraph by laying down that one test should be selected and by referring to the higher overall migration obtained under the two testing conditions required in that test. |
| --- | --- |

(36)

The second paragraph of Chapter 3.2 of Annex V of the Regulation sets out conditions for the substitution of the overall migration (OM) test 7 with the OM tests 8 or 9 when it is not technically feasible to perform the OM test 7 with simulant D2. The wording of that paragraph does not clearly specify by which test OM 7 should be substituted, and makes reference to the highest overall migration in the last sentence, which could be erroneously interpreted in such a way that more than two OM tests should be conducted. It is therefore appropriate to clarify the paragraph by laying down that one test should be selected and by referring to the higher overall migration obtained under the two testing conditions required in that test.

| (37) | Regulation (EU) No 10/2011 should therefore be amended and corrected accordingly. |
| --- | --- |

(37)

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

| (38) | Plastic materials and articles complying with Regulation (EU) No 10/2011, as applicable before the date of the entry into force of this Regulation, and which were also placed on the market before that date, should be allowed to be placed on the market for two more years and remain on the market until the exhaustion of stocks. However, this long period should not be used to develop new materials and articles which had not yet been placed on the market at the time of entry into force of this Regulation, and are not yet compliant with it. Business operators may not be able to fully anticipate the entry into force of this Regulation when they would have been already planning to place such new materials on the market before the entry into force of this Regulation. Therefore it is appropriate to allow such placing on the market of new materials and articles based on the old rules for six months after the entry into force of this Regulation. |
| --- | --- |

(38)

Plastic materials and articles complying with Regulation (EU) No 10/2011, as applicable before the date of the entry into force of this Regulation, and which were also placed on the market before that date, should be allowed to be placed on the market for two more years and remain on the market until the exhaustion of stocks. However, this long period should not be used to develop new materials and articles which had not yet been placed on the market at the time of entry into force of this Regulation, and are not yet compliant with it. Business operators may not be able to fully anticipate the entry into force of this Regulation when they would have been already planning to place such new materials on the market before the entry into force of this Regulation. Therefore it is appropriate to allow such placing on the market of new materials and articles based on the old rules for six months after the entry into force of this Regulation.

| (39) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(39)

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

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

| (1) | in Article 6(3), point (a) is replaced by the following:






  ‘(a) | all salts of substances for which “yes” is indicated in column 2 in Table 1 of Annex II of authorised acids, phenols or alcohols, and subject to the restrictions set out in column 3 and 4 of that table’; |
| --- | --- | --- |

(1)

in Article 6(3), point (a) is replaced by the following:

‘(a)

all salts of substances for which “yes” is indicated in column 2 in Table 1 of Annex II of authorised acids, phenols or alcohols, and subject to the restrictions set out in column 3 and 4 of that table’;

| (2) | Annexes I, II, IV and V are amended in accordance with the Annex to this Regulation. |
| --- | --- |

(2)

Annexes I, II, IV and V are amended in accordance with the Annex to this Regulation.

Article 2

Plastic materials and articles complying with Regulation (EU) No 10/2011 as applicable before the entry into force of this Regulation, and which were first placed on the market before 23 March 2021 may continue to be placed on the market until 23 September 2022 and remain on the market until the 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, 2 September 2020.

For the Commission

The President

Ursula VON DER LEYEN

---

(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)  
  EFSA Journal 2018; 16(11)5449.

3

EFSA Journal

(4)  
  EFSA Journal 2009; 7(10):1364.

4

EFSA Journal

(5)  
  EFSA Journal 2019; 17(1):5552.

5

EFSA Journal

(6)  
  EFSA Journal 2019; 17(5):5679.

6

EFSA Journal

(7)  
  EFSA Journal 2019; 17(6):5737.

7

EFSA Journal

(8)  EFSA Journal 2004; 24 (1-13):2903.

8

(9)  Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (OJ L 95, 7.4.2017, p. 1).

9

(10)  
  EFSA Journal 2009; 7(10):1351.

10

EFSA Journal

(11)  
  EFSA Journal 2009; 980 (1-131).

11

EFSA Journal

(12)  
  EFSA Journal 2014;12(3):3595.

12

EFSA Journal

(13)  
  EFSA Journal 2010; 8(4):1570.

13

EFSA Journal

(14)  
  EFSA Journal 2012;10(12):2985.

14

EFSA Journal

(15)  Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).

15

---

ANNEX

Annexes I, II, IV, and V to Regulation (EU) No 10/2011 are amended as follows:

| (1) | Annex I is amended as follows:






  (a) | in point 1, Table 1 is amended as follows:






  (i) | entry 236 on 1,3-phenylenediamine is replaced by the following:















  ‘236 | 23050 | 0000108-45-2 | 1,3-phenylenediamine | no | yes | no | ND | | | (28)’ |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

(1)

Annex I is amended as follows:

(a)

in point 1, Table 1 is amended as follows:

(i)

entry 236 on 1,3-phenylenediamine is replaced by the following:

‘236

23050

0000108-45-2

1,3-phenylenediamine

no

yes

no

ND

(28)’

| (ii) | entry 398 on antimony trioxide is replaced by the following:















  ‘398 | 35760 | 0001309-64-4 | antimony trioxide | yes | no | no | | | | (6)’ |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

(ii)

entry 398 on antimony trioxide is replaced by the following:

‘398

35760

0001309-64-4

antimony trioxide

yes

no

no

(6)’

| (iii) | the following entries are inserted in numerical order:















  ‘1075 | | | Montmorillonite clay modified with hexadecyltrimethylammonium bromide | yes | no | no | | | Only to be used as additive at up to 4,0 % w/w in polylactic acid plastics intended for long-term storage of water at ambient temperature or below.
  Can form platelets in the nanoform that are in one or two dimensions thinner than 100 nm. Such platelets shall be oriented parallel to the polymer surface and shall be fully embedded in the polymer. | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 1076 | | 1227937-46-3 | Phosphorous acid, triphenyl ester, polymer with alpha-hydro-omega-hydroxypoly[oxy(methyl-1,2-ethanediyl)], C10-16 alkyl ester | yes | no | no | 0,05 | | Only to be used as an additive at up to 0,2 % w/w in high impact polystyrene materials and articles intended contact with food at room temperature and below, including hot-fill and/or heating up to 100 °C for up to 2 hours. It shall not be used in contact with foods for which simulant C and/or D1 is assigned in Annex III. | |
| 1077 | | | Titanium dioxide surface-treated with fluoride-modified alumina | yes | no | no | | | Only to be used at up to 25,0 % w/w, including in the nanoform. | 29’ |

(iii)

the following entries are inserted in numerical order:

‘1075

Montmorillonite clay modified with hexadecyltrimethylammonium bromide

yes

no

no

Only to be used as additive at up to 4,0 % w/w in polylactic acid plastics intended for long-term storage of water at ambient temperature or below.

Can form platelets in the nanoform that are in one or two dimensions thinner than 100 nm. Such platelets shall be oriented parallel to the polymer surface and shall be fully embedded in the polymer.

1076

1227937-46-3

Phosphorous acid, triphenyl ester, polymer with alpha-hydro-omega-hydroxypoly[oxy(methyl-1,2-ethanediyl)], C10-16 alkyl ester

yes

no

no

0,05

Only to be used as an additive at up to 0,2 % w/w in high impact polystyrene materials and articles intended contact with food at room temperature and below, including hot-fill and/or heating up to 100 °C for up to 2 hours. It shall not be used in contact with foods for which simulant C and/or D1 is assigned in Annex III.

1077

Titanium dioxide surface-treated with fluoride-modified alumina

yes

no

no

Only to be used at up to 25,0 % w/w, including in the nanoform.

29’

| (b) | in point 3 of Table 3, the following entries are added:






  ‘28 | A detection limit of 0,002 mg/kg food or food simulant applies |
| --- | --- | --- |
| 29 | In polar polymers which swell in contact with foods for which simulant B is assigned in Annex III, there is a risk that under severe contact conditions the migration limits for aluminium and fluoride are exceeded. Under contact conditions above 4 hours at 100 °C this exceedance can be high.’ |

(b)

in point 3 of Table 3, the following entries are added:

‘28

A detection limit of 0,002 mg/kg food or food simulant applies

29

In polar polymers which swell in contact with foods for which simulant B is assigned in Annex III, there is a risk that under severe contact conditions the migration limits for aluminium and fluoride are exceeded. Under contact conditions above 4 hours at 100 °C this exceedance can be high.’

| (2) | Annex II is replaced in its entirety by the following:


  ‘ANNEX II

  Restrictions on plastic materials and articles

  The following restrictions on plastic materials and articles apply:






  1. | Plastic materials and articles shall not release the substances in Table 1 below in quantities exceeding the specific migration limits expressed in mg/kg food or simulant specified in column (3), and subject to the remarks in Column (4).
  Substances listed in Table 1 shall only be used in accordance with the compositional requirements set out in Chapter II. If Chapter II does not provide a basis for the authorised use of such a substance, that substance may only be present as an impurity subject to the restrictions specified in Table 1.

  Table 1


  General list of migration limits for substances migrating from plastic materials and articles









  (1) | (2) | (3) | (4) |
| --- | --- | --- | --- | --- | --- |
| Name | Salts allowed in accordance with Article 6(3)(a) | SML [mg/kg food or food simulant] | Remark |
| Aluminium | yes | 1 | |
| Ammonium | yes | - | (1) |
| Antimony | no | 0,04 | (2) |
| Arsenic | no | ND | |
| Barium | yes | 1 | |
| Cadmium | no | ND (LOD 0,002) | |
| Calcium | yes | - | (1) |
| Chromium | no | ND | (3) |
| Cobalt | yes | 0,05 | |
| Copper | yes | 5 | |
| Europium | yes | 0,05 | (4) |
| Gadolinium | yes | 0,05 | (4) |
| Iron | yes | 48 | |
| Lanthanum | yes | 0,05 | (4) |
| Lead | no | ND | |
| Lithium | yes | 0,6 | |
| Magnesium | yes | - | (1) |
| Manganese | yes | 0,6 | |
| Mercury | no | ND | |
| Nickel | no | 0,02 | |
| Potassium | yes | - | (1) |
| Sodium | yes | - | (1) |
| Terbium | yes | 0,05 | (4) |
| Zinc | yes | 5 | |
| ND: | Not Detectable; detection limit assigned in accordance with second subparagraph of Article 11(4); LOD: specified Limit of Detection. |

(2)

Annex II is replaced in its entirety by the following:

‘ANNEX II

Restrictions on plastic materials and articles

The following restrictions on plastic materials and articles apply:

1.

Plastic materials and articles shall not release the substances in Table 1 below in quantities exceeding the specific migration limits expressed in mg/kg food or simulant specified in column (3), and subject to the remarks in Column (4).

Substances listed in Table 1 shall only be used in accordance with the compositional requirements set out in Chapter II. If Chapter II does not provide a basis for the authorised use of such a substance, that substance may only be present as an impurity subject to the restrictions specified in Table 1.

Table 1

General list of migration limits for substances migrating from plastic materials and articles

(1)

(2)

(3)

(4)

Name

Salts allowed in accordance with Article 6(3)(a)

SML [mg/kg food or food simulant]

Remark

Aluminium

yes

1

Ammonium

yes

-

(1)

Antimony

no

0,04

(2)

Arsenic

no

ND

Barium

yes

1

Cadmium

no

ND (LOD 0,002)

Calcium

yes

-

(1)

Chromium

no

ND

(3)

Cobalt

yes

0,05

Copper

yes

5

Europium

yes

0,05

(4)

Gadolinium

yes

0,05

(4)

Iron

yes

48

Lanthanum

yes

0,05

(4)

Lead

no

ND

Lithium

yes

0,6

Magnesium

yes

-

(1)

Manganese

yes

0,6

Mercury

no

ND

Nickel

no

0,02

Potassium

yes

-

(1)

Sodium

yes

-

(1)

Terbium

yes

0,05

(4)

Zinc

yes

5

ND:

Not Detectable; detection limit assigned in accordance with second subparagraph of Article 11(4); LOD: specified Limit of Detection.

Remarks

| (1) | The migration is subject to Article 11(3) and Article 12 |
| --- | --- |

(1)

The migration is subject to Article 11(3) and Article 12

| (2) | The note in Annex I, Table 1, FCM No 398 applies: SML might be exceeded at very high temperature |
| --- | --- |

(2)

The note in Annex I, Table 1, FCM No 398 applies: SML might be exceeded at very high temperature

| (3) | To verify compliance with the Regulation, the detection limit of 0,01 mg/kg shall apply for total chromium. However if the operator that placed the material on the market can prove on the basis of pre-existing documentary evidence that the presence of hexavalent chromium in the material is excluded because it is not used or formed or during the entire production process, a limit for the total chromium of 3,6 mg/kg food shall apply. |
| --- | --- |

(3)

To verify compliance with the Regulation, the detection limit of 0,01 mg/kg shall apply for total chromium. However if the operator that placed the material on the market can prove on the basis of pre-existing documentary evidence that the presence of hexavalent chromium in the material is excluded because it is not used or formed or during the entire production process, a limit for the total chromium of 3,6 mg/kg food shall apply.

| (4) | The lanthanide substances europium, gadolinium, lanthanum, and/or terbium can be used in accordance with Article 6(3)(a) provided that:






  (a) | The sum of all lanthanide substances migrating to the food or food simulant does not exceed the specific migration limit of 0,05 mg/kg; and |
| --- | --- | --- |

(4)

The lanthanide substances europium, gadolinium, lanthanum, and/or terbium can be used in accordance with Article 6(3)(a) provided that:

(a)

The sum of all lanthanide substances migrating to the food or food simulant does not exceed the specific migration limit of 0,05 mg/kg; and

| (b) | analytical evidence using a well described methodology demonstrating that the lanthanide substance(s) used are present in dissociated ionic form in the food or the food simulant, forms part of the documentation referred to in Article 16. |
| --- | --- |

(b)

analytical evidence using a well described methodology demonstrating that the lanthanide substance(s) used are present in dissociated ionic form in the food or the food simulant, forms part of the documentation referred to in Article 16.

| 2. | Primary aromatic amines (“PAAs”) listed in entry 43 to Appendix 8 of Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council (*1) and for which no migration limit is specified in Table 1 of Annex I shall not migrate or shall not otherwise be released from plastic materials and articles into food or food simulant. They shall not be detectable using analytical equipment with a limit of detection of 0,002 mg/kg food or food simulant applied to each individual primary aromatic amine (“PAA”), in accordance with Article 11(4).
  For PAAs not listed in entry 43 to Appendix 8 of Annex XVII to Regulation (EC) No 1907/2006, but for which no specific migration limit is specified in Annex I, compliance with Article 3 of Regulation (EC) No 1935/2004 shall be verified in accordance with Article 19. The sum of those PAAs shall however not exceed 0,01 mg/kg in food or food simulant. |
| --- | --- |

2.

Primary aromatic amines (“PAAs”) listed in entry 43 to Appendix 8 of Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council (*1) and for which no migration limit is specified in Table 1 of Annex I shall not migrate or shall not otherwise be released from plastic materials and articles into food or food simulant. They shall not be detectable using analytical equipment with a limit of detection of 0,002 mg/kg food or food simulant applied to each individual primary aromatic amine (“PAA”), in accordance with Article 11(4).

For PAAs not listed in entry 43 to Appendix 8 of Annex XVII to Regulation (EC) No 1907/2006, but for which no specific migration limit is specified in Annex I, compliance with Article 3 of Regulation (EC) No 1935/2004 shall be verified in accordance with Article 19. The sum of those PAAs shall however not exceed 0,01 mg/kg in food or food simulant.

(*1)  Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).;"

*1

| (3) | in Annex IV, point 6 is replaced by the following:






  ‘(6) | adequate information relative to the substances used or products of degradation thereof for which restrictions and/or specifications are set out in Annex I and II to the Regulation to allow the downstream business operators to ensure compliance with the Regulation.
  At intermediate stages, this information shall include the identification and amount of substances in the intermediate material,






  — | that are subject to restrictions in Annex II, or |
| --- | --- | --- | --- |

(3)

in Annex IV, point 6 is replaced by the following:

‘(6)

adequate information relative to the substances used or products of degradation thereof for which restrictions and/or specifications are set out in Annex I and II to the Regulation to allow the downstream business operators to ensure compliance with the Regulation.

At intermediate stages, this information shall include the identification and amount of substances in the intermediate material,

—

that are subject to restrictions in Annex II, or

| — | for which genotoxicity has not been ruled out, and which originate from an intentional use during a manufacturing stage of that intermediate material and which could be present in an amount that foreseeably gives rise to a migration from the final material exceeding 0,00015 mg/kg food or food simulant.’; |
| --- | --- |

—

for which genotoxicity has not been ruled out, and which originate from an intentional use during a manufacturing stage of that intermediate material and which could be present in an amount that foreseeably gives rise to a migration from the final material exceeding 0,00015 mg/kg food or food simulant.’;

| (4) | Annex V is amended as follows:






  (a) | Chapter 2 is amended as follows:






  (i) | in the second paragraph of point 2.1.3, the following subparagraph is added:






  ‘(iv) | if the plastic material or article intended to come into contact with food of which the compliance must be verified becomes in its final application part of a food processing equipment or an appliance, or a part thereof, the migration tests may be carried out by determining the specific migration into the food or food simulant produced or processed by the whole equipment or appliance, or the part thereof, as appropriate, subject to the following conditions:






  — | the food or food simulant is processed during testing by the equipment or part thereof in accordance with the worst foreseeable conditions that can be achieved if the equipment or its part is operated in accordance with its operating instructions, and |
| --- | --- | --- | --- | --- | --- |

(4)

Annex V is amended as follows:

(a)

Chapter 2 is amended as follows:

(i)

in the second paragraph of point 2.1.3, the following subparagraph is added:

‘(iv)

if the plastic material or article intended to come into contact with food of which the compliance must be verified becomes in its final application part of a food processing equipment or an appliance, or a part thereof, the migration tests may be carried out by determining the specific migration into the food or food simulant produced or processed by the whole equipment or appliance, or the part thereof, as appropriate, subject to the following conditions:

—

the food or food simulant is processed during testing by the equipment or part thereof in accordance with the worst foreseeable conditions that can be achieved if the equipment or its part is operated in accordance with its operating instructions, and

| — | the migration from parts used for storage such as from reservoirs, containers, or capsules or pads which are part of the equipment during the processing of the food, is determined using conditions representative for their use, unless the applied testing conditions for the whole tested equipment or appliance are representative also of their use. |
| --- | --- |

—

the migration from parts used for storage such as from reservoirs, containers, or capsules or pads which are part of the equipment during the processing of the food, is determined using conditions representative for their use, unless the applied testing conditions for the whole tested equipment or appliance are representative also of their use.

When migration testing is done under the above conditions, and the transfer of constituents from the equipment or appliance as a whole does not exceed the migration limits, the plastic parts or materials present in the equipment or appliance shall be considered to comply with Article 11(1).

The testing of the parts used for storage or supply such as reservoirs, containers, capsules or pads shall be under conditions representative of their use, and shall include the foreseeable storage conditions of the food in these parts.

The supporting documentation referred to in Article 16 shall clearly document the testing on the whole food processing and/or food producing equipment or appliance, or on parts thereof. It shall demonstrate that the testing was representative of its foreseeable use, and shall indicate for which substances migration testing was carried out and provide all testing results. The manufacturer of individual plastic parts shall ensure the absence of migration for substances for which the Regulation specifies that their migration shall not be detectable at a specified level of detection in accordance with Article 11(4).

Compliance documentation supplied in accordance with the Regulation to the producer of the final equipment or appliance, or part thereof, shall list all substances subject to migration limits that might be exceeded under the foreseeable use of the supplied part or material.

When the result is not in compliance with the Regulation it shall be determined whether the source of the non-compliance is a plastic part subject to the Regulation or a part made from another material not subject to the Regulation on the basis of documentary evidence or analytical testing. Without prejudice to Article 3 of Regulation (EU) No 1935/2004, non-compliance to the Regulation shall only be established if the migration originates from a plastic part.’;

| (ii) | point 2.1.6, is replaced in its entirety by the following:






  ‘2.1.6. | Repeated use materials and articles

  If the material or article is intended to come into repeated contact with foods, the migration test(s) shall be carried out three times on a single sample using another portion of food simulant on each occasion. The specific migration in the second test shall not exceed the level observed in the first test, and the specific migration in the third test shall not exceed the level observed in the second test.
  Compliance of the material or article shall than be verified on the basis of the level of the migration found in the third test and on the basis of the stability of the material or article from the first to the third migration test. The stability of the material shall be considered insufficient if migration is observed above the level of detection in any of the three migration tests, and increases from the first migration test to the third migration test. In case of insufficient stability, compliance of the material shall not be established even in case the specific migration limit is not exceeded in any of the three tests.
  However, if there is conclusive scientific proof that the level of the migration decreases in the second and third tests and if the migration limits are not exceeded on the first test, no further test is necessary.
  Irrespective of the above rules, a material or article shall never be considered to comply with this Regulation if in the first test a substance that is prohibited from migrating or from being released in detectable quantities under Article 11(4) is detected.’; |
| --- | --- | --- |

(ii)

point 2.1.6, is replaced in its entirety by the following:

‘2.1.6.

Repeated use materials and articles

Repeated use materials and articles

If the material or article is intended to come into repeated contact with foods, the migration test(s) shall be carried out three times on a single sample using another portion of food simulant on each occasion. The specific migration in the second test shall not exceed the level observed in the first test, and the specific migration in the third test shall not exceed the level observed in the second test.

Compliance of the material or article shall than be verified on the basis of the level of the migration found in the third test and on the basis of the stability of the material or article from the first to the third migration test. The stability of the material shall be considered insufficient if migration is observed above the level of detection in any of the three migration tests, and increases from the first migration test to the third migration test. In case of insufficient stability, compliance of the material shall not be established even in case the specific migration limit is not exceeded in any of the three tests.

However, if there is conclusive scientific proof that the level of the migration decreases in the second and third tests and if the migration limits are not exceeded on the first test, no further test is necessary.

Irrespective of the above rules, a material or article shall never be considered to comply with this Regulation if in the first test a substance that is prohibited from migrating or from being released in detectable quantities under Article 11(4) is detected.’;

| (b) | Chapter 3 is amended as follows:






  (i) | in point 3.1, Table 3 and the four paragraphs below Table 3 are replaced by the following:

  ‘Table 3


  Standardised conditions for testing the overall migration








  Column 1 | Column 2 | Column 3 |
| --- | --- | --- | --- | --- |
| Test number | Contact time in days [d] or hours [h] at Contact temperature in [°C] for testing | Intended food contact conditions |
| OM0 | 30 min at 40 °C | Any food contact at cold or ambient temperatures and for a short duration (≤ 30 minutes). |
| OM1 | 10 d at 20 °C | Any food contact at frozen and refrigerated conditions |
| OM2 | 10 d at 40 °C | Any long-term storage at room temperature or below, including when packaged under hot-fill conditions, and/or heating up to a temperature T where 70 °C ≤ T ≤ 100 °C for a maximum of t = 120/2^((T-70)/10) minutes. |
| OM3 | 2 h at 70 °C | Any food contact conditions that include hot-fill and/or heating up to a temperature T where 70 °C ≤ T ≤ 100 °C for maximum of t = 120/2^((T-70)/10) minutes, which are not followed by long-term room temperature or refrigerated storage. |
| OM4 | 1 h at 100 °C or at reflux | High temperature applications for all types of food at temperature up to 100 °C. |
| OM5 | 2 h at 100 °C or at reflux or alternatively 1 h at 121 °C | High temperature applications up to 121 °C. |
| OM6 | 4 h at 100 °C or at reflux | Any food contact conditions at a temperature exceeding 40 °C, and with foods for which point 4 of Annex III assigns simulants A, B, C or D1. |
| OM7 | 2 h at 175 °C | High temperature applications with fatty foods exceeding the conditions of OM5. |
| Test OM 7 covers also food contact conditions described for OM0, OM1, OM2, OM3, OM4, OM5. It represents the worst case conditions for fatty food simulants in contact with non-polyolefins. In case it is technically not feasible to perform OM 7 with food simulant D2 the test can be replaced as set out in paragraph 3.2.
  Test OM 6 covers also food contact conditions described for OM0, OM1, OM2, OM3, OM4 and OM5. It represents worst case conditions for food simulants A, B and C in contact with non-polyolefins.
  Test OM 5 covers also food contact conditions described for OM0, OM1, OM2, OM3, OM4. It represents the worst case conditions for all food simulants in contact with polyolefins.
  Test OM 2 covers also food contact conditions described for OM0, OM1 and OM3.’ |

(b)

Chapter 3 is amended as follows:

(i)

in point 3.1, Table 3 and the four paragraphs below Table 3 are replaced by the following:

‘Table 3

‘Table 3

Standardised conditions for testing the overall migration

Standardised conditions for testing the overall migration

Column 1

Column 2

Column 3

Test number

Contact time in days [d] or hours [h] at Contact temperature in [°C] for testing

Intended food contact conditions

OM0

30 min at 40 °C

Any food contact at cold or ambient temperatures and for a short duration (≤ 30 minutes).

OM1

10 d at 20 °C

Any food contact at frozen and refrigerated conditions

OM2

10 d at 40 °C

Any long-term storage at room temperature or below, including when packaged under hot-fill conditions, and/or heating up to a temperature T where 70 °C ≤ T ≤ 100 °C for a maximum of t = 120/2^((T-70)/10) minutes.

OM3

2 h at 70 °C

Any food contact conditions that include hot-fill and/or heating up to a temperature T where 70 °C ≤ T ≤ 100 °C for maximum of t = 120/2^((T-70)/10) minutes, which are not followed by long-term room temperature or refrigerated storage.

OM4

1 h at 100 °C or at reflux

High temperature applications for all types of food at temperature up to 100 °C.

OM5

2 h at 100 °C or at reflux or alternatively 1 h at 121 °C

High temperature applications up to 121 °C.

OM6

4 h at 100 °C or at reflux

Any food contact conditions at a temperature exceeding 40 °C, and with foods for which point 4 of Annex III assigns simulants A, B, C or D1.

OM7

2 h at 175 °C

High temperature applications with fatty foods exceeding the conditions of OM5.

Test OM 7 covers also food contact conditions described for OM0, OM1, OM2, OM3, OM4, OM5. It represents the worst case conditions for fatty food simulants in contact with non-polyolefins. In case it is technically not feasible to perform OM 7 with food simulant D2 the test can be replaced as set out in paragraph 3.2.

Test OM 6 covers also food contact conditions described for OM0, OM1, OM2, OM3, OM4 and OM5. It represents worst case conditions for food simulants A, B and C in contact with non-polyolefins.

Test OM 5 covers also food contact conditions described for OM0, OM1, OM2, OM3, OM4. It represents the worst case conditions for all food simulants in contact with polyolefins.

Test OM 2 covers also food contact conditions described for OM0, OM1 and OM3.’

| (ii) | in point 3.2, the paragraphs before the table are replaced by the following:

  ‘If it is not technically feasible to perform one or more of the tests OM0 to OM6 in food simulant D2, migration tests shall be done using ethanol 95 % and isooctane. In addition a test shall be done using food simulant E in case the worst foreseeable conditions of use exceed 100 °C. The test that results in the highest overall migration shall be used to establish compliance with the Regulation.
  In case it is technically not feasible to perform OM7 with food simulant D2, either test OM8 or test OM9 shall be selected as a replacement test by selecting the most appropriate of these two tests on the basis of the intended and the foreseeable use of the material or article that is being tested. Subsequently, a migration test shall be done at each of the two test conditions specified for the selected test, using a new test sample for each test condition. The test condition that results in the higher overall migration shall be used to establish compliance with the Regulation.’; |
| --- | --- |

(ii)

in point 3.2, the paragraphs before the table are replaced by the following:

‘If it is not technically feasible to perform one or more of the tests OM0 to OM6 in food simulant D2, migration tests shall be done using ethanol 95 % and isooctane. In addition a test shall be done using food simulant E in case the worst foreseeable conditions of use exceed 100 °C. The test that results in the highest overall migration shall be used to establish compliance with the Regulation.

In case it is technically not feasible to perform OM7 with food simulant D2, either test OM8 or test OM9 shall be selected as a replacement test by selecting the most appropriate of these two tests on the basis of the intended and the foreseeable use of the material or article that is being tested. Subsequently, a migration test shall be done at each of the two test conditions specified for the selected test, using a new test sample for each test condition. The test condition that results in the higher overall migration shall be used to establish compliance with the Regulation.’;

| (iii) | point 3.3.2 is replaced in its entirety by the following:






  ‘3.3.2. | Repeated use articles and materials

  The applicable overall migration test shall be carried out three times on a single sample using another portion of food simulant on each occasion. The migration shall be determined using an analytical method in accordance with the requirements of Article 34 of Regulation (EU) 2017/625 of the European Parliament and of the Council (*2). The overall migration in the second test shall be lower than in the first test, and the overall migration in the third test shall be lower than in the second test. Compliance with the overall migration limit shall be verified on the basis of the level of the overall migration found in the third test.
  If it is not technically feasible to test the same sample three times, such as when testing in vegetable oil, the overall migration test can be carried out by testing different samples for three different periods of time lasting one, two and three times the applicable contact test time. The difference between the third and the second test results shall be considered to represent the overall migration. Compliance shall be verified on the basis of this difference, which shall not exceed the overall migration limit. In addition, the difference between the second and the first test results shall be lower than the first test results and the difference between the third and the second test results shall be lower than the difference between the second and the first test results.
  By derogation from the first paragraph, if, on the basis of scientific evidence, it is established that for the material or article being tested the overall migration decreases in the second and third tests and if the overall migration limit is not exceeded in the first test, the first test alone shall be sufficient. |
| --- | --- | --- |

(iii)

point 3.3.2 is replaced in its entirety by the following:

‘3.3.2.

Repeated use articles and materials

Repeated use articles and materials

The applicable overall migration test shall be carried out three times on a single sample using another portion of food simulant on each occasion. The migration shall be determined using an analytical method in accordance with the requirements of Article 34 of Regulation (EU) 2017/625 of the European Parliament and of the Council (*2). The overall migration in the second test shall be lower than in the first test, and the overall migration in the third test shall be lower than in the second test. Compliance with the overall migration limit shall be verified on the basis of the level of the overall migration found in the third test.

*2

If it is not technically feasible to test the same sample three times, such as when testing in vegetable oil, the overall migration test can be carried out by testing different samples for three different periods of time lasting one, two and three times the applicable contact test time. The difference between the third and the second test results shall be considered to represent the overall migration. Compliance shall be verified on the basis of this difference, which shall not exceed the overall migration limit. In addition, the difference between the second and the first test results shall be lower than the first test results and the difference between the third and the second test results shall be lower than the difference between the second and the first test results.

By derogation from the first paragraph, if, on the basis of scientific evidence, it is established that for the material or article being tested the overall migration decreases in the second and third tests and if the overall migration limit is not exceeded in the first test, the first test alone shall be sufficient.

(*2)  Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, p. 1).’
  "

*2

---

(*1)  Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).;

*1

(*2)  Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, p. 1).’
  ”

*2

---

| 3.9.2020 | EN | Official Journal of the European Union | L 288/18 |
| --- | --- | --- | --- |

3.9.2020

EN

Official Journal of the European Union

L 288/18

---

COMMISSION IMPLEMENTING REGULATION (EU) 2020/1246

of 2 September 2020

concerning the non-renewal of the approval of the active substance fenamiphos, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011

(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 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 20(1) and Article 78(2) thereof,

Whereas:

| (1) | Commission Directive 2006/85/EC (2) included fenamiphos as an active substance in Annex I to Council Directive 91/414/EEC (3). |
| --- | --- |

(1)

Commission Directive 2006/85/EC (2) included fenamiphos as an active substance in Annex I to Council Directive 91/414/EEC (3).

| (2) | Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4). |
| --- | --- |

(2)

Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4).

| (3) | The approval of the active substance fenamiphos, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 July 2021. |
| --- | --- |

(3)

The approval of the active substance fenamiphos, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 July 2021.

| (4) | An application for the renewal of the approval of the active substance fenamiphos was submitted in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) within the time period provided for in that Article. |
| --- | --- |

(4)

An application for the renewal of the approval of the active substance fenamiphos was submitted in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) within the time period provided for in that Article.

| (5) | The applicant submitted the supplementary dossiers required in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be complete by the rapporteur Member State. |
| --- | --- |

(5)

The applicant submitted the supplementary dossiers required in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be complete by the rapporteur Member State.

| (6) | The rapporteur Member State prepared a renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (‘the Authority’) and the Commission on 2 October 2017. |
| --- | --- |

(6)

The rapporteur Member State prepared a renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (‘the Authority’) and the Commission on 2 October 2017.

| (7) | The Authority made the supplementary summary dossier available to the public. The Authority also circulated the renewal assessment report to the applicants and to the Member States for comments and launched a public consultation on it. The Authority forwarded the comments received to the Commission. |
| --- | --- |

(7)

The Authority made the supplementary summary dossier available to the public. The Authority also circulated the renewal assessment report to the applicants and to the Member States for comments and launched a public consultation on it. The Authority forwarded the comments received to the Commission.

| (8) | On 10 December 2018, the Authority communicated to the Commission its conclusion (6) on whether fenamiphos can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. |
| --- | --- |

(8)

On 10 December 2018, the Authority communicated to the Commission its conclusion (6) on whether fenamiphos can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

| (9) | The Authority identfied a number of concerns. In particular, the overall consumer risk assessment was considered to be provisional since the data package for metabolities M01 and M02 on genotoxicity was incomplete, leading to a provisional residue definition for risk assessment for crops on which fenamiphos is intended to be used. However, even if the consumer risk assessment could not be finalised, an acute risk for consumers was identified for all the representative uses concerning fruiting vegetables. |
| --- | --- |

(9)

The Authority identfied a number of concerns. In particular, the overall consumer risk assessment was considered to be provisional since the data package for metabolities M01 and M02 on genotoxicity was incomplete, leading to a provisional residue definition for risk assessment for crops on which fenamiphos is intended to be used. However, even if the consumer risk assessment could not be finalised, an acute risk for consumers was identified for all the representative uses concerning fruiting vegetables.

| (10) | Additionally, for the chronic intake consumer exposure, if the calculated maximum residue levels (MRLs) resulting from the available residue dataset submitted for the renewal process are used in the exposure assessment, the maximum theoretical daily intake (TMDI) would account for 172 % of the acceptable daily intake (ADI). |
| --- | --- |

(10)

Additionally, for the chronic intake consumer exposure, if the calculated maximum residue levels (MRLs) resulting from the available residue dataset submitted for the renewal process are used in the exposure assessment, the maximum theoretical daily intake (TMDI) would account for 172 % of the acceptable daily intake (ADI).

| (11) | Furthermore, as regards the remaining uses of the substance on ornamentals and nursery stock, given that those plants can be grown in rotation with food crops, an acute consumer risk deriving from these uses could not be excluded considering the possible uptake of residues in rotational crops. |
| --- | --- |

(11)

Furthermore, as regards the remaining uses of the substance on ornamentals and nursery stock, given that those plants can be grown in rotation with food crops, an acute consumer risk deriving from these uses could not be excluded considering the possible uptake of residues in rotational crops.

| (12) | Finally, the risk assessment to unique human metabolities could not be finalised since an in vitro comparative metabolism study was not submitted. |
| --- | --- |

(12)

Finally, the risk assessment to unique human metabolities could not be finalised since an in vitro comparative metabolism study was not submitted.

| (13) | The Commission invited the applicant to submit its comments on the conclusion of the Authority. Furthermore, in accordance with the third subparagraph of Article 14(1) of Implementing Regulation (EU) No 844/2012, the Commission invited the applicant to submit comments on the renewal report. The applicant submitted its comments, which have been carefully examined. |
| --- | --- |

(13)

The Commission invited the applicant to submit its comments on the conclusion of the Authority. Furthermore, in accordance with the third subparagraph of Article 14(1) of Implementing Regulation (EU) No 844/2012, the Commission invited the applicant to submit comments on the renewal report. The applicant submitted its comments, which have been carefully examined.

| (14) | However, despite the arguments put forward by the applicant, the concerns regarding the active substance could not be eliminated. |
| --- | --- |

(14)

However, despite the arguments put forward by the applicant, the concerns regarding the active substance could not be eliminated.

| (15) | Consequently, it has not been established with respect to one or more representative uses of at least one plant protection product that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate not to renew the approval of the active substance fenamiphos in accordance with Article 20(1)(b) of that Regulation. |
| --- | --- |

(15)

Consequently, it has not been established with respect to one or more representative uses of at least one plant protection product that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate not to renew the approval of the active substance fenamiphos in accordance with Article 20(1)(b) of that Regulation.

| (16) | Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly. |
| --- | --- |

(16)

Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

| (17) | Member States should be given sufficient time to withdraw authorisations for plant protection products containing fenamiphos. |
| --- | --- |

(17)

Member States should be given sufficient time to withdraw authorisations for plant protection products containing fenamiphos.

| (18) | For plant protection products containing fenamiphos, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should not exceed 12 months from the date of entry into force of this Regulation. |
| --- | --- |

(18)

For plant protection products containing fenamiphos, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should not exceed 12 months from the date of entry into force of this Regulation.

| (19) | Commission Implementing Regulation (EU) 2020/869 (7) extended the approval period of fenamiphos to 31 July 2021 in order to allow the renewal process to be completed before the expiry of the approval period of that substance. However, given that a decision on the non-renewal of the approval is being taken ahead of the expiry of that extended approval period, this Regulation should apply as soon as possible. |
| --- | --- |

(19)

Commission Implementing Regulation (EU) 2020/869 (7) extended the approval period of fenamiphos to 31 July 2021 in order to allow the renewal process to be completed before the expiry of the approval period of that substance. However, given that a decision on the non-renewal of the approval is being taken ahead of the expiry of that extended approval period, this Regulation should apply as soon as possible.

| (20) | This Regulation does not prevent the submission of a further application for the approval of fenamiphos pursuant to Article 7 of Regulation (EC) No 1107/2009. |
| --- | --- |

(20)

This Regulation does not prevent the submission of a further application for the approval of fenamiphos pursuant to Article 7 of Regulation (EC) No 1107/2009.

| (21) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(21)

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

Non-renewal of the approval of the active substance

The approval of the active substance fenamiphos is not renewed.

Article 2

Amendment to Implementing Regulation (EU) No 540/2011

In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 141, on fenamiphos, is deleted.

Article 3

Transitional measures

Member States shall withdraw authorisations for plant protection products containing fenamiphos as an active substance by 23 March 2021.

Article 4

Grace period

Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) No 1107/2009 shall expire by 23 September 2021.

Article 5

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.

Official Journal of the European Union

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

Done at Brussels, 2 September 2020.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  
  OJ L 309, 24.11.2009, p. 1.

1

(2)  Commission Directive 2006/85/EC of 23 October 2006 amending Council Directive 91/414/EEC to include fenamiphos and ethephon as active substances (OJ L 293, 24.10.2006, p. 3).

2

(3)  Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).

3

(4)  Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).

4

(5)  Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 252, 19.9.2012, p. 26).

5

(6)  EFSA (European Food Safety Authority) 2019. Conclusion on the peer review of the pesticide risk assessment of the active substance fenamiphos. EFSA Journal 2019;17(1):5557, 26 pp. https://doi.org/10.2903/j.efsa.2019.5557

6

EFSA Journal

(7)  Commission Implementing Regulation (EU) 2020/869 of 24 June 2020 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances beflubutamid, benalaxyl, benthiavalicarb, bifenazate, boscalid, bromoxynil, captan, cyazofamid, dimethomorph, ethephon, etoxazole, famoxadone, fenamiphos, flumioxazine, fluoxastrobin, folpet, formetanate, metribuzin, milbemectin, Paecilomyces lilacinus strain 251, phenmedipham, phosmet, pirimiphos-methyl, propamocarb, prothioconazole and S-metolachlor (OJ L 201, 25.6.2020, p. 7).

7

---

| 3.9.2020 | EN | Official Journal of the European Union | L 288/21 |
| --- | --- | --- | --- |

3.9.2020

EN

Official Journal of the European Union

L 288/21

---

COMMISSION IMPLEMENTING REGULATION (EU) 2020/1247

of 2 September 2020

operating deductions from fishing quotas available for certain stocks in 2020 on account of overfishing in the previous years

THE EUROPEAN COMMISSION,

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

Having regard to Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Union control system for ensuring compliance with the rules of the common fisheries policy, amending Regulations (EC) No 847/96, (EC) No 2371/2002, (EC) No 811/2004, (EC) No 768/2005, (EC) No 2115/2005, (EC) No 2166/2005, (EC) No 388/2006, (EC) No 509/2007, (EC) No 676/2007, (EC) No 1098/2007, (EC) No 1300/2008, (EC) No 1342/2008 and repealing Regulations (EEC) No 2847/93, (EC) No 1627/94 and (EC) No 1966/2006 (1), and in particular Article 105(1), (2) and (3) thereof,

Whereas:

| (1) | Fishing quotas for the year 2019 have been established by:






  — | Council Regulation (EU) 2018/1628 (2), |
| --- | --- | --- |

(1)

Fishing quotas for the year 2019 have been established by:

—

Council Regulation (EU) 2018/1628 (2),

| — | Council Regulation (EU) 2018/2025 (3), |
| --- | --- |

—

Council Regulation (EU) 2018/2025 (3),

| — | Council Regulation (EU) 2018/2058 (4), and |
| --- | --- |

—

Council Regulation (EU) 2018/2058 (4), and

| — | Council Regulation(EU) 2019/124 (5). |
| --- | --- |

—

Council Regulation(EU) 2019/124 (5).

| (2) | Fishing quotas for the year 2020 have been established by:






  — | Council Regulation (EU) 2018/2025, |
| --- | --- | --- |

(2)

Fishing quotas for the year 2020 have been established by:

—

Council Regulation (EU) 2018/2025,

| — | Council Regulation (EU) 2019/1838 (6), |
| --- | --- |

—

Council Regulation (EU) 2019/1838 (6),

| — | Council Regulation (EU) 2019/2236 (7), and |
| --- | --- |

—

Council Regulation (EU) 2019/2236 (7), and

| — | Council Regulation (EU) 2020/123 (8). |
| --- | --- |

—

Council Regulation (EU) 2020/123 (8).

| (3) | Pursuant to Article 105(1) of Regulation (EC) No 1224/2009, when the Commission has established that a Member State has exceeded the fishing quotas which have been allocated to it, the Commission is to operate deductions from future fishing quotas of that Member State. |
| --- | --- |

(3)

Pursuant to Article 105(1) of Regulation (EC) No 1224/2009, when the Commission has established that a Member State has exceeded the fishing quotas which have been allocated to it, the Commission is to operate deductions from future fishing quotas of that Member State.

| (4) | Article 105(2) and (3) of Regulation (EC) No 1224/2009 provides that such deductions have to be operated in the following year or years by applying the respective multiplying factors as set out therein. |
| --- | --- |

(4)

Article 105(2) and (3) of Regulation (EC) No 1224/2009 provides that such deductions have to be operated in the following year or years by applying the respective multiplying factors as set out therein.

| (5) | Certain Member States have exceeded their fishing quotas for the year 2019. It is therefore appropriate to operate deductions on the fishing quotas allocated to them in 2020 and, where relevant, in subsequent years, for the overfished stocks. |
| --- | --- |

(5)

Certain Member States have exceeded their fishing quotas for the year 2019. It is therefore appropriate to operate deductions on the fishing quotas allocated to them in 2020 and, where relevant, in subsequent years, for the overfished stocks.

| (6) | Commission Implementing Regulation (EU) 2019/1726 (9) and Commission Implementing Regulation (EU) 2020/112 (10) have set out deductions from fishing quotas for certain Member States and species for 2019. However, for certain Member States, the deductions to be applied for some species were higher than the respective quotas available in 2019 and could therefore not be operated entirely in that year. To ensure that in such cases the full amount for the respective stocks be deducted, the remaining quantities should be taken into account when establishing deductions for 2020 and, where appropriate, from subsequent quotas. |
| --- | --- |

(6)

Commission Implementing Regulation (EU) 2019/1726 (9) and Commission Implementing Regulation (EU) 2020/112 (10) have set out deductions from fishing quotas for certain Member States and species for 2019. However, for certain Member States, the deductions to be applied for some species were higher than the respective quotas available in 2019 and could therefore not be operated entirely in that year. To ensure that in such cases the full amount for the respective stocks be deducted, the remaining quantities should be taken into account when establishing deductions for 2020 and, where appropriate, from subsequent quotas.

| (7) | Deductions from fishing quotas, as provided for by this Regulation, should apply without prejudice to deductions applicable to 2020 quotas pursuant to Commission Implementing Regulation (EU) No 185/2013 (11). |
| --- | --- |

(7)

Deductions from fishing quotas, as provided for by this Regulation, should apply without prejudice to deductions applicable to 2020 quotas pursuant to Commission Implementing Regulation (EU) No 185/2013 (11).

| (8) | Since quotas are expressed in tonnes, overfishing involving quantities of less than one tonne should not be considered, |
| --- | --- |

(8)

Since quotas are expressed in tonnes, overfishing involving quantities of less than one tonne should not be considered,

HAS ADOPTED THIS REGULATION:

Article 1

1.   The fishing quotas fixed in Regulations (EU) 2018/2025, (EU) 2019/1838, (EU) 2019/2236 and (EU) 2020/123 for the year 2020 shall be reduced as set out in the Annex to this Regulation.

2.   Paragraph 1 shall apply without prejudice to deductions provided for in Implementing Regulation (EU) No 185/2013.

Article 2

This Regulation shall enter into force on the seventh 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, 2 September 2020.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  
  OJ L 343, 22.12.2009, p. 1.

1

(2)  Council Regulation (EU) 2018/1628 of 30 October 2018 fixing for 2019 the fishing opportunities for certain fish stocks and groups of fish stocks applicable in the Baltic Sea and amending Regulation (EU) 2018/120 as regards certain fishing opportunities in other waters (OJ L 272, 31.10.2018, p. 1).

2

(3)  Council Regulation (EU) 2018/2025 of 17 December 2018 fixing for 2019 and 2020 the fishing opportunities for Union fishing vessels for certain deep-sea fish stocks (OJ L 325, 20.12.2018, p. 7).

3

(4)  Council Regulation (EU) 2018/2058 of 17 December 2018 fixing for 2019 the fishing opportunities for certain fish stocks and groups of fish stocks in the Black Sea (OJ L 329, 27.12.2018, p. 8).

4

(5)  Council Regulation (EU) 2019/124 of 30 January 2019 fixing for 2019 the fishing opportunities for certain fish stocks and groups of fish stocks, applicable in Union waters and, for Union fishing vessels, in certain non-Union waters (OJ L 29, 31.1.2019, p. 1).

5

(6)  Council Regulation (EU) 2019/1838 of 30 October 2019 fixing for 2020 the fishing opportunities for certain fish stocks and groups of fish stocks applicable in the Baltic Sea and amending Regulation (EU) 2019/124 as regards certain fishing opportunities in other waters (OJ L 281, 31.10.2019, p. 1).

6

(7)  Council Regulation (EU) 2019/2236 of 16 December 2019 fixing for 2020 the fishing opportunities for certain fish stocks and groups of fish stocks applicable in the Mediterranean and Black Seas (OJ L 336, 30.12.2019, p. 14).

7

(8)  Council Regulation (EU) 2020/123 of 27 January 2020 fixing for 2020 the fishing opportunities for certain fish stocks and groups of fish stocks, applicable in Union waters and, for Union fishing vessels, in certain non-Union waters (OJ L 25, 30.1.2020, p. 1).

8

(9)  Commission Implementing Regulation (EU) 2019/1726 of 15 October 2019 operating deductions from fishing quotas available for certain stocks in 2019 on account of overfishing in the previous years (OJ L 263, 16.10.2019, p. 3).

9

(10)  Commission Implementing Regulation (EU) 2020/112 of 22 January 2020 operating deductions from fishing quotas available for certain stocks in 2019 on account of overfishing of other stocks in the previous years and amending Implementing Regulation (EU) 2019/1726 (OJ L 21, 27.1.2020, p. 6).

10

(11)  Commission Implementing Regulation (EU) No 185/2013 of 5 March 2013 providing for deductions from certain fishing quotas allocated to Spain in 2013 and subsequent years on account of overfishing of a certain mackerel quota in 2009 (OJ L 62, 6.3.2013, p. 1).

11

---

ANNEX

DEDUCTIONS FROM FISHING QUOTAS FOR THE YEAR 2020 FOR STOCKS WHICH HAVE BEEN OVERFISHED

| Member State | Species code | Area code | Species name | Area name | Initial quota 2019 (in kilograms) | Permitted landings 2019 (Total adapted quantity in kilograms) (1) | Total catches 2019 (quantity in kilograms) | Quota consumption related to permitted landings | Overfishing related to permitted landing (quantity in kilograms) | Multiplying factor (2) | Additional Multiplying factor (3), (4) | Outstanding deductions from previous year(s) (5) (quantity in kilograms) | Deductions to apply in 2020 (quantity in kilograms) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| DE | HER | 4AB. | Herring | Union and Norwegian waters of 4 north of 53° 30′ N | 39 404 000 | 25 460 900 | 27 182 070 | 106,76 % | 1 721 170 | / | / | / | 1 721 170 |
| DE | MAC | 2CX14- | Mackerel | 3a and 4; Union waters of 2a, 3b, 3c and Subdivisions 22-32 | 441 000 | 14 859 024 | 15 542 581 | 104,60 % | 683 557 | / | / | / | 683 557 |
| DK | MAC | 2CX14- | Mackerel | 6, 7, 8a, 8b, 8d and 8e; Union and international waters of 5b; international waters of 2a, 12 and 14 | / | 2 688 463 | 2 693 920 | 100,20 % | 5 457 | / | / | / | 5 457 |
| DK | MAC | 2A34. | Mackerel | 3a and 4; Union waters of 2a, 3b, 3c and Subdivisions 22-32 | 14 480 000 | 13 330 744 | 14 022 305 | 105,19 % | 691 561 | / | / | / | 691 561 |
| DK | MAC | 2A4A-N | Mackerel | Norwegian waters of 2a and 4a | 10 242 000 | 10 252 106 | 11 197 228 | 109,22 % | 945 122 | / | / | / | 945 122 |
| DK | POK | 1N2AB. | Saithe | Norwegian waters of 1 and 2 | / | 17 000 | 50 968 | 299,81 % | 50 968 | 1,00 | / | / | 50 968 |
| ES | BET | ATLANT | Bigeye tuna | Atlantic Ocean | 9 415 300 | 8 941 151 | 9 095 090 | 101,72 % | 153 939 | / | C (6) | / | 153 939 |
| ES | COD | 1/2B. | Cod | 1 and 2b | 11 562 000 | 8 455 844 | 8 463 118 | 100,09 % | 7 274 | / | / | / | 7 274 |
| ES | GHL | 1N2AB. | Greenland halibut | Norwegian waters of 1 and 2 | / | 2 000 | 14 225 | 711,25 % | 12 225 | 1,00 | A | / | 18 338 |
| ES | OTH | 1N2AB. | Other species | Norwegian waters of 1 and 2 | / | 31 800 | 35 695 | 112,25 % | 3 895 | 1,00 | / | / | 3 895 |
| ES | POK | 1N2AB. | Saithe | Norwegian waters of 1 and 2 | / | 196 000 | 198 607 | 101,33 % | 2 607 | / | / | / | 2 607 |
| ES | RED | N3LN. | Redfish | NAFO 3LN | / | 515 100 | 517 806 | 100,53 % | 2 706 | / | / | / | 2 706 |
| ES | RJU | 9-C. | Undulate ray | Union waters of 9 | 15 000 | 15 000 | 15 511 | 103,41 % | 511 (7) | N/A | N/A | 2 067 | 2 067 |
| FR | BET | ATLANT | Bigeye tuna | Atlantic Ocean | 4 167 700 | 4 167 700 | 4 687 551 | 112,47 % | 519 851 | 1,20 | C | / | 883 747 |
| FR | RJE | 7FG. | Small-eyed ray | Union waters of 7f and 7g | 79 000 | 90 399 | 91 485 | 101,20 % | 1 086 | / | / | / | 1 086 |
| FR | RJU | 7DE. | Undulate ray | Union waters of 7d and 7e | 103 000 | 168 000 | 177 718 | 105,78 % | 9 718 | / | / | / | 9 718 |
| FR | SWO | AS05N | Swordfish | Atlantic Ocean, South of 5° N | / | / | 3 500 | N/A | 3 500 | / | / | / | 3 500 |
| GB | COD | N1GL14 | Cod | Greenland waters of NAFO 1F and Greenland waters of 5, 12 and 14 | 364 000 | 353 500 | 353 500 | 100 % | 0 | / | / | 4 167 | 4 167 |
| GB | HER | 4AB. | Herring | Union and Norwegian waters of 4 north of 53° 30′ N | 55 583 000 | 62 320 196 | 62 607 628 | 100,46 % | 287 432 | / | / | / | 287 432 |
| GB | MAC | 2CX14- | Mackerel | 6, 7, 8a, 8b, 8d and 8e; Union and international waters of 5b; international waters of 2a, 12 and 14 | 152 115 000 | 145 768 635 | 154 072 694 | 105,70 % | 8 304 059 | / | A (6) | / | 8 304 059 |
| GB | RJU | 7DE. | Undulate ray | Union waters of 7d and 7e | 58 000 | 61 200 | 63 133 | 103,16 % | 1 933 | / | / | / | 1 933 |
| EL | BFT | AE45WM | Bluefin tuna | Atlantic Ocean, east of 45° W, and Mediterranean | 285 110 | 304 110 | 312 690 | 102,82 % | 8 580 | / | C (6) | / | 8 580 |
| IE | ALB | AN05N | Northern albacore | Atlantic Ocean, north of 5° N | 2 854 300 | 3 115 420 | 3 213 170 | 103,14 % | 97 750 | / | C (6) | / | 97 750 |
| NL | HER | 4CXB7D | Herring | 4c, 7d except Blackwater stock | 18 162 000 | 19 497 305 | 19 512 481 | 100,08 % | 15 176 | / | / | / | 15 176 |
| NL | MAC | 2A34. | Mackerel | 3a and 4; Union waters of 2a, 3b, 3c and Subdivisions 22-32 | 1 342 000 | 1 494 000 | 2 012 324 | 134,69 % | 518 324 | 1,40 | / | / | 725 654 |
| PT | ALB | AN05N | Northern albacore | Atlantic Ocean, north of 5° N | 1 994 200 | 1 794 200 | 2 463 161 | 137,28 % | 668 961 | 1,40 | C | / | 1 271 026 |
| PT | ALF | 3X14- | Alfonsinos | Union and international waters of 3, 4, 5, 6, 7, 8, 9, 10, 12 and 14 | 164 000 | 149 034 | 156 756 | 105,18 % | 7 722 | / | A (6) | / | 7 722 |
| PT | BUM | ATLANT | Blue marlin | Atlantic Ocean | 50 440 | 7 076 | 18 016 | 254,61 % | 10 940 | 1,00 | A | / | 10 940 |
| PT | RJU | 9-C. | Undulate ray | Union waters of 9 | 15 000 | 21 705 | 24 589 | 113,29 % | 2 884 | 1,00 | / | / | 2 884 |
| PT | SWO | AN05N | Swordfish | Atlantic Ocean, North of 5° N | 1 010 390 | 2 410 390 | 2 414 333 | 100,16 % | 3 943 | / | / | / | 3 943 |
| SE | MAC | 2A34. | Mackerel | 3a and 4; Union waters of 2a, 3b, 3c and Subdivisions 22-32 | 4 034 000 | 2 945 203 | 3 075 839 | 104,44 % | 130 636 | / | / | / | 130 636 |

Member State

Species code

Area code

Species name

Area name

Initial quota 2019 (in kilograms)

Permitted landings 2019 (Total adapted quantity in kilograms) (1)

Total catches 2019 (quantity in kilograms)

Quota consumption related to permitted landings

Overfishing related to permitted landing (quantity in kilograms)

Multiplying factor (2)

Additional Multiplying factor (3), (4)

Outstanding deductions from previous year(s) (5) (quantity in kilograms)

Deductions to apply in 2020 (quantity in kilograms)

DE

HER

4AB.

Herring

Union and Norwegian waters of 4 north of 53° 30′ N

39 404 000

25 460 900

27 182 070

106,76 %

1 721 170

/

/

/

1 721 170

DE

MAC

2CX14-

Mackerel

3a and 4; Union waters of 2a, 3b, 3c and Subdivisions 22-32

441 000

14 859 024

15 542 581

104,60 %

683 557

/

/

/

683 557

DK

MAC

2CX14-

Mackerel

6, 7, 8a, 8b, 8d and 8e; Union and international waters of 5b; international waters of 2a, 12 and 14

/

2 688 463

2 693 920

100,20 %

5 457

/

/

/

5 457

DK

MAC

2A34.

Mackerel

3a and 4; Union waters of 2a, 3b, 3c and Subdivisions 22-32

14 480 000

13 330 744

14 022 305

105,19 %

691 561

/

/

/

691 561

DK

MAC

2A4A-N

Mackerel

Norwegian waters of 2a and 4a

10 242 000

10 252 106

11 197 228

109,22 %

945 122

/

/

/

945 122

DK

POK

1N2AB.

Saithe

Norwegian waters of 1 and 2

/

17 000

50 968

299,81 %

50 968

1,00

/

/

50 968

ES

BET

ATLANT

Bigeye tuna

Atlantic Ocean

9 415 300

8 941 151

9 095 090

101,72 %

153 939

/

C (6)

/

153 939

ES

COD

1/2B.

Cod

1 and 2b

11 562 000

8 455 844

8 463 118

100,09 %

7 274

/

/

/

7 274

ES

GHL

1N2AB.

Greenland halibut

Norwegian waters of 1 and 2

/

2 000

14 225

711,25 %

12 225

1,00

A

/

18 338

ES

OTH

1N2AB.

Other species

Norwegian waters of 1 and 2

/

31 800

35 695

112,25 %

3 895

1,00

/

/

3 895

ES

POK

1N2AB.

Saithe

Norwegian waters of 1 and 2

/

196 000

198 607

101,33 %

2 607

/

/

/

2 607

ES

RED

N3LN.

Redfish

NAFO 3LN

/

515 100

517 806

100,53 %

2 706

/

/

/

2 706

ES

RJU

9-C.

Undulate ray

Union waters of 9

15 000

15 000

15 511

103,41 %

511 (7)

N/A

N/A

2 067

2 067

FR

BET

ATLANT

Bigeye tuna

Atlantic Ocean

4 167 700

4 167 700

4 687 551

112,47 %

519 851

1,20

C

/

883 747

FR

RJE

7FG.

Small-eyed ray

Union waters of 7f and 7g

79 000

90 399

91 485

101,20 %

1 086

/

/

/

1 086

FR

RJU

7DE.

Undulate ray

Union waters of 7d and 7e

103 000

168 000

177 718

105,78 %

9 718

/

/

/

9 718

FR

SWO

AS05N

Swordfish

Atlantic Ocean, South of 5° N

/

/

3 500

N/A

3 500

/

/

/

3 500

GB

COD

N1GL14

Cod

Greenland waters of NAFO 1F and Greenland waters of 5, 12 and 14

364 000

353 500

353 500

100 %

0

/

/

4 167

4 167

GB

HER

4AB.

Herring

Union and Norwegian waters of 4 north of 53° 30′ N

55 583 000

62 320 196

62 607 628

100,46 %

287 432

/

/

/

287 432

GB

MAC

2CX14-

Mackerel

6, 7, 8a, 8b, 8d and 8e; Union and international waters of 5b; international waters of 2a, 12 and 14

152 115 000

145 768 635

154 072 694

105,70 %

8 304 059

/

A (6)

/

8 304 059

GB

RJU

7DE.

Undulate ray

Union waters of 7d and 7e

58 000

61 200

63 133

103,16 %

1 933

/

/

/

1 933

EL

BFT

AE45WM

Bluefin tuna

Atlantic Ocean, east of 45° W, and Mediterranean

285 110

304 110

312 690

102,82 %

8 580

/

C (6)

/

8 580

IE

ALB

AN05N

Northern albacore

Atlantic Ocean, north of 5° N

2 854 300

3 115 420

3 213 170

103,14 %

97 750

/

C (6)

/

97 750

NL

HER

4CXB7D

Herring

4c, 7d except Blackwater stock

18 162 000

19 497 305

19 512 481

100,08 %

15 176

/

/

/

15 176

NL

MAC

2A34.

Mackerel

3a and 4; Union waters of 2a, 3b, 3c and Subdivisions 22-32

1 342 000

1 494 000

2 012 324

134,69 %

518 324

1,40

/

/

725 654

PT

ALB

AN05N

Northern albacore

Atlantic Ocean, north of 5° N

1 994 200

1 794 200

2 463 161

137,28 %

668 961

1,40

C

/

1 271 026

PT

ALF

3X14-

Alfonsinos

Union and international waters of 3, 4, 5, 6, 7, 8, 9, 10, 12 and 14

164 000

149 034

156 756

105,18 %

7 722

/

A (6)

/

7 722

PT

BUM

ATLANT

Blue marlin

Atlantic Ocean

50 440

7 076

18 016

254,61 %

10 940

1,00

A

/

10 940

PT

RJU

9-C.

Undulate ray

Union waters of 9

15 000

21 705

24 589

113,29 %

2 884

1,00

/

/

2 884

PT

SWO

AN05N

Swordfish

Atlantic Ocean, North of 5° N

1 010 390

2 410 390

2 414 333

100,16 %

3 943

/

/

/

3 943

SE

MAC

2A34.

Mackerel

3a and 4; Union waters of 2a, 3b, 3c and Subdivisions 22-32

4 034 000

2 945 203

3 075 839

104,44 %

130 636

/

/

/

130 636

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(1)  Quotas available to a Member State pursuant to the relevant fishing opportunities Regulations after taking into account exchanges of fishing opportunities in accordance with Article 16(8) of Regulation (EU) No 1380/2013 of the European Parliament and of the Council (OJ L 354, 28.12.2013, p. 22), quota transfers from 2018 to 2019 in accordance with Article 4(2) of Council Regulation (EC) No 847/96 (OJ L 115, 9.5.1996, p. 3) and with Article 15(9) of Regulation (EU) No 1380/2013 or reallocation and deduction of fishing opportunities in accordance with Articles 37 and 105 of Regulation (EC) No 1224/2009.

(2)  As set out in Article 105(2) of Regulation (EC) No 1224/2009. Deduction equal to the overfishing * 1,00 shall apply in all cases of overfishing equal to, or less than, 100 tonnes.

(3)  As set out in Article 105(3) of Regulation (EC) No 1224/2009 and provided that the extent of overfishing exceeds 10 %.

(4)  Letter ‘A’ indicates that an additional multiplying factor of 1,5 has been applied due to consecutive overfishing in the years 2017, 2018 and 2019. Letter ‘C’ indicates that an additional multiplying factor of 1,5 has been applied as the stock is subject to a multiannual plan.

(5)  Remaining quantities from previous year(s).

(6)  Additional multiplying factor not applicable because the overfishing does not exceed 10 % of the permitted landings.

(7)  Quantities below 1 tonne are not considered.

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III Other acts

EUROPEAN ECONOMIC AREA

| 3.9.2020 | EN | Official Journal of the European Union | L 288/26 |
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3.9.2020

EN

Official Journal of the European Union

L 288/26

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EFTA SURVEILLANCE AUTHORITY DELEGATED DECISION No 47/20/COL

of 25 May 2020

authorising Norway to derogate from certain common aviation safety rules pursuant to Article 14(6) of Regulation (EC) No 216/2008 [2020/1248]

THE EFTA SURVEILLANCE AUTHORITY,

Having regard to the Act referred to at point 66n of Annex XIII to the EEA Agreement,

Having regard to Regulation (EC) No 216/2008 of the European Parliament and of the Council of 20 February 2008 on common rules in the field of civil aviation and establishing a European Aviation Safety Agency, and repealing Council Directive 91/670/EEC, Regulation (EC) No 1592/2002 and Directive 2004/36/EC (1), as amended (‘the Act’), as adapted to the EEA Agreement by Protocol 1 thereto, and by the Decision of the EEA Joint Committee No 163/2011, and in particular point 3(e) of the Annex to that Decision.

Having regard in particular to Articles 14(6) and 14(7) of the Act,

Having regard to the opinion of the EFTA Transport Committee delivered on 6 May 2020 in the form of tacit approval, the initial date for the opinion having been subject to a one-month extension on an exceptional basis as a result of the coronavirus crisis,

Whereas:

Norway notified the EFTA Surveillance Authority (‘the Authority’) and the European Aviation Safety Agency (‘the Agency’) of its intention to derogate from the requirements of FCL.905.SFI of Annex I of Commission Regulation (EU) No 1178/2011 (2) by granting Synthetic Flight Instructors (‘SFI’s) the privilege to provide instructions for applicants for an SFI certificate without meeting the requirement to have at least 3 years of experience as Type Rating Instructor (TRI).

Article 14(6) of the Act states that where an equivalent level of protection to that attained by the application of the rules implementing the Regulation can be achieved by other means, Member States may, without discrimination on grounds of nationality grant an approval derogating from those implementing rules.

Pursuant to Article 14(7) of the Act, the Authority has assessed the need for, and the level of protection emerging from, the derogation requested, based on a recommendation from the Agency, issued on 29 October 2019 (Doc No 1094402) and corrected on 6 November 2019 (Doc. No 1095781). The Authority has also taken note of a similar derogation having been positively assessed by the European Commission in Commission Decision 2014/69/EU (3) and concludes that the variation will provide for a level of protection equivalent to the one attained by the application of the common aviation safety rules, provided certain conditions are met.

Pursuant to Article 1 of EEA Joint Committee Decision No 163/2011 and adaptation (a) set out in point 3 of the Annex thereto, the term ‘Member State(s)’ is to be understood to include, in addition to its meaning in the Regulation, the EFTA States.

In accordance with Article 14(7) of the Act, a derogation granted to one EFTA State shall be notified to all EFTA States, which shall also be entitled to apply that derogation. This Decision should therefore be addressed to all EFTA States. The description of each derogation, as well as the conditions attached to it, should be such as to enable other EFTA States to apply that measure when they are in the same situation, without requiring a further approval from the Authority. Nevertheless, EFTA States should notify the application of derogations, as they may have effects outside that EFTA State.

The measures provided for in this Decision are in accordance with the opinion of the EFTA Transport Committee,

HAS ADOPTED THIS DECISION:

| 1. | Norway may derogate from the requirements in point FCL.905.SFI of Annex I of Regulation (EU) No 1178/2011, as specified in the Annex to this Decision, provided that conditions specified in point 4 of the Annex to this Decision are complied with. |
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1.

| 2. | All EFTA States shall be entitled to apply the same measure as specified in the Annex to this Decision. EFTA States shall notify the Authority, the Agency and the national aviation authorities thereof. |
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2.

| 3. | The Decision is addressed to EFTA States. It is authentic in the English language. |
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3.

| 4. | This Decision shall be notified to Norway, Iceland and Liechtenstein. |
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4.

Done at Brussels, 25 May 2020.

For the EFTA Surveillance Authority, acting under Delegation Decision No 103/13/COL

Högni KRISTJÁNSSON

Responsible College Member

Carsten ZATSCHLER

Countersigning as Director,

Legal and Executive Affairs

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(1)  
  OJ L 79, 19.3.2008, p. 1.

1

(2)  Commission Regulation (EU) No 1178/2011 of 3 November 2011 laying down technical requirements and administrative procedures related to civil aviation aircrew pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council (OJ L 311, 25.11.2011, p. 1), as adapted to the EEA Agreement by Protocol 1 thereto.

2

(3)  Commission Decision 2014/69/EU of 6 February 2014 authorising Sweden and the United Kingdom to derogate from certain common aviation safety rules pursuant to Article 14(6) of Regulation (EC) No 216/2008 of the European Parliament and of the Council (OJ L 39, 8.2.2014, p. 60).

3

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ANNEX

Derogation by EFTA States from Regulation (EU) No 1178/2011 with respect to the privileges and conditions for the Synthetic Flight Instructor

1.   Description of the request

Provision FCL.905.SFI of Annex I to Regulation (EU) No 1178/2011 establishes the privileges of the Synthetic Flight Instructor (SFI) and does not allow the SFI to provide instruction to applicants for the SFI certificate. Part-FCL gives the privilege to provide this instruction only to holders of a Type Rating Instructor (TRI) certificate, provided that they have at least 3 years of experience as TRI.

By letter dated 11 July 2019 (Doc. No 1080642), the Norwegian Government notified the Authority of its intention to derogate from the requirements of FCL.905.SFI of Annex I. The Norwegian Government notified the European Aviation Safety Agency (‘Agency’) by letter dated 20 August 2019 (Doc. No 1084282).

Norway proposed to grant SFIs the privilege to provide instructions for applicants for an SFI certificate without meeting the requirement to have at least 3 years of experience as TRI.

2.   Assessment of the request

2.1.   Need

According to Norway, the current provision of FCL.905.SFI of Annex I to Regulation (EU) No 1178/2011 does not allow an SFI to provide instruction to applicants for the SFI certificate. Part-FCL gives the privilege to provide this instruction to holders of a TRI certificate, provided that they have at least 3 years of experience as TRI. Many SFIs working as tutors in SFI courses in Norway cannot comply with the requirement to become a TRI with 3 years of experience. Such SFIs will therefore be unable to continue to act as tutors in SFI courses. Furthermore, many of the current SFIs would be unable to fulfil the TRI requirements for medical reasons.

Based on an assessment of the current situation, made by Norway, there is an insufficient number of TRIs to teach a sufficient number of applicants for an SFI certificate and to meet the industry’s training needs. As a result, there will be a shortage of qualified instructors to provide this training, which would cause a disruption to the training of pilots, particular in the business/corporate aircraft domain unless a derogation is given.

2.2.   Equivalency of the level of protection

Norway proposed to allow SFIs that do not fulfil the requirements of having at least 3 years of experience as a TRI to provide instruction for the SFI applicants. Such SFIs shall have a minimum of 3 years of experience of instruction as an SFI and have completed a specific 2-day SFI tutor course provided by an SFI tutor and have passed an assessment of competence. In addition, Norway proposed to require these SFIs to pass an assessment of competence during an SFI training course in order to maintain the validity of their SFI tutor privilege.

The Agency, agreed with Norway’s assessment that an equivalent level of protection to that attained by the application of the common aviation safety rules is achieved by the intended derogation, specifically with the additional training and checking requirements suggested.

3.   Description of the derogation

Norway may, by derogation from FCL.905.SFI of Annex I to Regulation (EU) No 1178/2011, grant the privilege to SFIs that do not fulfil the requirement of having at least 3 years of experience as TRI, to provide instruction for the SFI applicants.

4.   Conditions attached to the application of the derogation

Such SFIs shall have a minimum of 3 years of experience of instruction as an SFI, shall complete a specific 2-day SFI tutor course provided by an SFI tutor and shall pass an assessment of competence.

5.   General applicability of the derogation

All EFTA States may apply this derogation provided that the conditions described in point 4 are met.

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Corrigenda

| 3.9.2020 | EN | Official Journal of the European Union | L 288/29 |
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3.9.2020

EN

Official Journal of the European Union

L 288/29

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Corrigendum to Regulation (EU) 2018/1861 of the European Parliament and of the Council of 28 November 2018 on the establishment, operation and use of the Schengen Information System (SIS) in the field of border checks, and amending the Convention implementing the Schengen Agreement, and amending and repealing Regulation (EC) No 1987/2006

(
  Official Journal of the European Union L 312 of 7 December 2018
  )

On page 42, in Article 45(7):

for:

| ‘7. | misuse of data, Member States, Europol and the European Border and Coast Guard Agency shall ensure that penalties are imposed in accordance with Article 59’, |
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‘7.

read:

| ‘7. | Where a security incident is caused by the misuse of data, Member States, Europol and the European Border and Coast Guard Agency shall ensure that penalties are imposed in accordance with Article 59.’. |
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‘7.

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