BETA


2024/2691(DEA) Definition of ‘engineered nanomaterials’

Progress: Procedure completed - delegated act rejected

RoleCommitteeRapporteurShadows
Lead ENVI PIETIKÄINEN Sirpa (icon: EPP EPP), SCHALDEMOSE Christel (icon: S&D S&D), RIES Frédérique (icon: Renew Renew), PAULUS Jutta (icon: Greens/EFA Greens/EFA), HAZEKAMP Anja (icon: The Left The Left)
Lead committee dossier:
Legal Basis:
R, u, l, e, s, , o, f, , P, r, o, c, e, d, u, r, e, , E, P, , 0, 1, 1, 4, -, p, 0, 3

Events

2024/08/29
   European Commission - Commission response to text adopted in plenary
Documents
2024/04/24
   EP - Decision by Parliament
Details

The European Parliament decided by 388 votes to 188, with 47 abstentions, to object to the Commission delegated regulation amending Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods as regards the definition of ‘engineered nanomaterials’.

Definition

Taking into account the possibility of food consisting of engineered nanomaterials being a novel food, Regulation (EU) 2015/2283 provides for a definition of engineered nanomaterial. Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers refers to the definition of ‘engineered nanomaterials’, in order to inform consumers of the presence of engineered nanomaterials in food.

Regulation (EU) 2015/2283 empowers the Commission to adjust and adapt the definition of ‘engineered nanomaterials’ referred to therein to technical and scientific progress or to definitions agreed at international level, by means of delegated acts, for the purposes of achieving the objectives of that Regulation.

Contradictions with recommendations and new scientific advancements

The Commission delegated regulation aims to address interpretation issues stemming from the current definition by introducing objective elements to determine whether a nanomaterial is ‘engineered’ or not, such as through replacing ‘intentionally produced [material]’ with ‘manufactured’.

The Commission delegated regulation precludes particles that are not in a solid state, such as micelles, liposomes, or nanoscale droplets in emulsion, and ingredients containing less than 50 % of particles less than 100 nm in size from being considered as nanomaterials in food.

The proposed default threshold value of 50 % or more particles at the nanoscale is arbitrary and less protective than the interpretation that has been given by some Member States, for example France of the definition in Regulation (EU) 2015/2283. That Regulation does not consider a size distribution threshold value for particles below 100 nm.

The proposed definition would potentially exclude many nano-substances from the scope of Regulation (EU) No 1169/2011, which would thus not be subject to the ‘[nano]’ labelling obligation.

The European Food Safety Authority recommended that in view of the current uncertainties over safety, a lower nanoparticle number threshold, e.g. 10 %, should be considered for food related applications instead of the currently proposed 50 % in the Recommendation.

However, according to the resolution, the nanoparticle number threshold of 50 % included in the horizontal ‘[nano]’ definition ‘is not based on sound scientific arguments’, and recommends setting a lower value for that threshold.

On this basis, Parliament objects to the Commission delegated regulation regretting that the proposed threshold of 50 % does not take into account technical and scientific progress.

Text adopted by Parliament, single reading

Documents
2024/04/24
   EP - Results of vote in Parliament
2024/04/18
   European Parliament - Motion for a resolution objecting delegated act
Documents
2024/04/10
   EP - Committee referral announced in Parliament
2024/03/22
   EP - PIETIKÄINEN Sirpa (EPP) appointed as rapporteur in ENVI
2024/03/22
   EP - SCHALDEMOSE Christel (S&D) appointed as rapporteur in ENVI
2024/03/22
   EP - RIES Frédérique (Renew) appointed as rapporteur in ENVI
2024/03/22
   EP - PAULUS Jutta (Greens/EFA) appointed as rapporteur in ENVI
2024/03/22
   EP - HAZEKAMP Anja (The Left) appointed as rapporteur in ENVI
2024/03/14
   European Commission - Non-legislative basic document
Documents
2024/03/14
   EC - Non-legislative basic document published
Documents
2024/03/14
   Initial period for examining delegated act 2.0 month(s)

Documents

Votes

B9-0225/2024 – Motion for a resolution #

2024/04/24 Outcome: +: 388, -: 188, 0: 47
FR ES PL BE EL DK IT SK AT EE HR FI PT DE IE LT LU MT RO LV NL SI SE BG CZ HU
Total
74
58
44
20
13
14
58
13
17
7
11
13
19
87
12
10
6
4
27
8
27
8
21
16
21
15
icon: S&D S&D
126

Belgium S&D

2

Greece S&D

1

Slovakia S&D

For (1)

1

Estonia S&D

2

Lithuania S&D

2

Luxembourg S&D

For (1)

1

Romania S&D

Against (1)

5

Latvia S&D

2

Slovenia S&D

2

Czechia S&D

For (1)

1
icon: Verts/ALE Verts/ALE
67

Spain Verts/ALE

3

Poland Verts/ALE

For (1)

1

Belgium Verts/ALE

3

Greece Verts/ALE

For (1)

1

Denmark Verts/ALE

2

Italy Verts/ALE

For (1)

1

Austria Verts/ALE

3

Finland Verts/ALE

3

Portugal Verts/ALE

1

Ireland Verts/ALE

2

Lithuania Verts/ALE

2

Luxembourg Verts/ALE

For (1)

1

Romania Verts/ALE

1

Netherlands Verts/ALE

3

Sweden Verts/ALE

3

Czechia Verts/ALE

3
icon: Renew Renew
95

Poland Renew

1

Greece Renew

1

Austria Renew

For (1)

1

Estonia Renew

3

Croatia Renew

For (1)

1

Finland Renew

For (1)

Against (1)

2

Ireland Renew

2

Lithuania Renew

1

Luxembourg Renew

2

Latvia Renew

For (1)

1

Slovenia Renew

2

Sweden Renew

For (1)

3

Bulgaria Renew

2

Hungary Renew

For (1)

1
icon: The Left The Left
30

Belgium The Left

For (1)

1

Greece The Left

2

Denmark The Left

1

Finland The Left

For (1)

1

Portugal The Left

2

Sweden The Left

For (1)

1

Czechia The Left

Against (1)

1
icon: ID ID
49

Denmark ID

For (1)

1
3

Estonia ID

For (1)

1

Czechia ID

Abstain (1)

1
icon: NI NI
37

France NI

For (1)

3

Belgium NI

For (1)

1

Croatia NI

Against (1)

Abstain (1)

2

Germany NI

Against (1)

3

Romania NI

For (1)

1

Latvia NI

1

Netherlands NI

Against (1)

1

Czechia NI

For (1)

1
icon: ECR ECR
61

France ECR

Against (1)

1

Greece ECR

1

Slovakia ECR

Abstain (1)

1

Croatia ECR

Against (1)

1

Finland ECR

2

Germany ECR

Against (1)

1

Lithuania ECR

1

Romania ECR

1

Latvia ECR

Abstain (1)

1

Netherlands ECR

Abstain (1)

5

Sweden ECR

3

Bulgaria ECR

2
icon: PPE PPE
158

Denmark PPE

Against (1)

1

Slovakia PPE

4

Estonia PPE

Against (1)

1

Croatia PPE

Abstain (1)

4

Finland PPE

Against (1)

3

Luxembourg PPE

2

Malta PPE

Against (1)

1

Latvia PPE

3

Slovenia PPE

4

Hungary PPE

Against (1)

1

History

(these mark the time of scraping, not the official date of the change)

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2024-04-24T00:00:00
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events/3/summary
  • The European Parliament decided by 388 votes to 188, with 47 abstentions, to object to the Commission delegated regulation amending Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods as regards the definition of ‘engineered nanomaterials’.
  • Definition
  • Taking into account the possibility of food consisting of engineered nanomaterials being a novel food, Regulation (EU) 2015/2283 provides for a definition of engineered nanomaterial. Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers refers to the definition of ‘engineered nanomaterials’, in order to inform consumers of the presence of engineered nanomaterials in food.
  • Regulation (EU) 2015/2283 empowers the Commission to adjust and adapt the definition of ‘engineered nanomaterials’ referred to therein to technical and scientific progress or to definitions agreed at international level, by means of delegated acts, for the purposes of achieving the objectives of that Regulation.
  • Contradictions with recommendations and new scientific advancements
  • The Commission delegated regulation aims to address interpretation issues stemming from the current definition by introducing objective elements to determine whether a nanomaterial is ‘engineered’ or not, such as through replacing ‘intentionally produced [material]’ with ‘manufactured’.
  • The Commission delegated regulation precludes particles that are not in a solid state, such as micelles, liposomes, or nanoscale droplets in emulsion, and ingredients containing less than 50 % of particles less than 100 nm in size from being considered as nanomaterials in food.
  • The proposed default threshold value of 50 % or more particles at the nanoscale is arbitrary and less protective than the interpretation that has been given by some Member States, for example France of the definition in Regulation (EU) 2015/2283. That Regulation does not consider a size distribution threshold value for particles below 100 nm.
  • The proposed definition would potentially exclude many nano-substances from the scope of Regulation (EU) No 1169/2011, which would thus not be subject to the ‘[nano]’ labelling obligation.
  • The European Food Safety Authority recommended that in view of the current uncertainties over safety, a lower nanoparticle number threshold, e.g. 10 %, should be considered for food related applications instead of the currently proposed 50 % in the Recommendation.
  • However, according to the resolution, the nanoparticle number threshold of 50 % included in the horizontal ‘[nano]’ definition ‘is not based on sound scientific arguments’, and recommends setting a lower value for that threshold.
  • On this basis, Parliament objects to the Commission delegated regulation regretting that the proposed threshold of 50 % does not take into account technical and scientific progress.
docs/2
date
2024-04-24T00:00:00
docs
url: https://www.europarl.europa.eu/doceo/document/TA-9-2024-0316_EN.html title: T9-0316/2024
type
Text adopted by Parliament, single reading
body
EP
events/3/summary
  • The European Parliament decided by 388 votes to 188, with 47 abstentions, to object to the Commission delegated regulation amending Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods as regards the definition of ‘engineered nanomaterials’.
  • Definition
  • Taking into account the possibility of food consisting of engineered nanomaterials being a novel food, Regulation (EU) 2015/2283 provides for a definition of engineered nanomaterial. Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers refers to the definition of ‘engineered nanomaterials’, in order to inform consumers of the presence of engineered nanomaterials in food.
  • Regulation (EU) 2015/2283 empowers the Commission to adjust and adapt the definition of ‘engineered nanomaterials’ referred to therein to technical and scientific progress or to definitions agreed at international level, by means of delegated acts, for the purposes of achieving the objectives of that Regulation.
  • Contradictions with recommendations and new scientific advancements
  • The Commission delegated regulation aims to address interpretation issues stemming from the current definition by introducing objective elements to determine whether a nanomaterial is ‘engineered’ or not, such as through replacing ‘intentionally produced [material]’ with ‘manufactured’.
  • The Commission delegated regulation precludes particles that are not in a solid state, such as micelles, liposomes, or nanoscale droplets in emulsion, and ingredients containing less than 50 % of particles less than 100 nm in size from being considered as nanomaterials in food.
  • The proposed default threshold value of 50 % or more particles at the nanoscale is arbitrary and less protective than the interpretation that has been given by some Member States, for example France of the definition in Regulation (EU) 2015/2283. That Regulation does not consider a size distribution threshold value for particles below 100 nm.
  • The proposed definition would potentially exclude many nano-substances from the scope of Regulation (EU) No 1169/2011, which would thus not be subject to the ‘[nano]’ labelling obligation.
  • The European Food Safety Authority recommended that in view of the current uncertainties over safety, a lower nanoparticle number threshold, e.g. 10 %, should be considered for food related applications instead of the currently proposed 50 % in the Recommendation.
  • However, according to the resolution, the nanoparticle number threshold of 50 % included in the horizontal ‘[nano]’ definition ‘is not based on sound scientific arguments’, and recommends setting a lower value for that threshold.
  • On this basis, Parliament objects to the Commission delegated regulation regretting that the proposed threshold of 50 % does not take into account technical and scientific progress.
docs/2
date
2024-04-24T00:00:00
docs
url: https://www.europarl.europa.eu/doceo/document/TA-9-2024-0316_EN.html title: T9-0316/2024
type
Text adopted by Parliament, single reading
body
EP
events/3/summary
  • The European Parliament decided by 388 votes to 188, with 47 abstentions, to object to the Commission delegated regulation amending Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods as regards the definition of ‘engineered nanomaterials’.
  • Definition
  • Taking into account the possibility of food consisting of engineered nanomaterials being a novel food, Regulation (EU) 2015/2283 provides for a definition of engineered nanomaterial. Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers refers to the definition of ‘engineered nanomaterials’, in order to inform consumers of the presence of engineered nanomaterials in food.
  • Regulation (EU) 2015/2283 empowers the Commission to adjust and adapt the definition of ‘engineered nanomaterials’ referred to therein to technical and scientific progress or to definitions agreed at international level, by means of delegated acts, for the purposes of achieving the objectives of that Regulation.
  • Contradictions with recommendations and new scientific advancements
  • The Commission delegated regulation aims to address interpretation issues stemming from the current definition by introducing objective elements to determine whether a nanomaterial is ‘engineered’ or not, such as through replacing ‘intentionally produced [material]’ with ‘manufactured’.
  • The Commission delegated regulation precludes particles that are not in a solid state, such as micelles, liposomes, or nanoscale droplets in emulsion, and ingredients containing less than 50 % of particles less than 100 nm in size from being considered as nanomaterials in food.
  • The proposed default threshold value of 50 % or more particles at the nanoscale is arbitrary and less protective than the interpretation that has been given by some Member States, for example France of the definition in Regulation (EU) 2015/2283. That Regulation does not consider a size distribution threshold value for particles below 100 nm.
  • The proposed definition would potentially exclude many nano-substances from the scope of Regulation (EU) No 1169/2011, which would thus not be subject to the ‘[nano]’ labelling obligation.
  • The European Food Safety Authority recommended that in view of the current uncertainties over safety, a lower nanoparticle number threshold, e.g. 10 %, should be considered for food related applications instead of the currently proposed 50 % in the Recommendation.
  • However, according to the resolution, the nanoparticle number threshold of 50 % included in the horizontal ‘[nano]’ definition ‘is not based on sound scientific arguments’, and recommends setting a lower value for that threshold.
  • On this basis, Parliament objects to the Commission delegated regulation regretting that the proposed threshold of 50 % does not take into account technical and scientific progress.
docs/2
date
2024-04-24T00:00:00
docs
url: https://www.europarl.europa.eu/doceo/document/TA-9-2024-0316_EN.html title: T9-0316/2024
type
Text adopted by Parliament, single reading
body
EP
events/3/summary
  • The European Parliament decided by 388 votes to 188, with 47 abstentions, to object to the Commission delegated regulation amending Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods as regards the definition of ‘engineered nanomaterials’.
  • Definition
  • Taking into account the possibility of food consisting of engineered nanomaterials being a novel food, Regulation (EU) 2015/2283 provides for a definition of engineered nanomaterial. Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers refers to the definition of ‘engineered nanomaterials’, in order to inform consumers of the presence of engineered nanomaterials in food.
  • Regulation (EU) 2015/2283 empowers the Commission to adjust and adapt the definition of ‘engineered nanomaterials’ referred to therein to technical and scientific progress or to definitions agreed at international level, by means of delegated acts, for the purposes of achieving the objectives of that Regulation.
  • Contradictions with recommendations and new scientific advancements
  • The Commission delegated regulation aims to address interpretation issues stemming from the current definition by introducing objective elements to determine whether a nanomaterial is ‘engineered’ or not, such as through replacing ‘intentionally produced [material]’ with ‘manufactured’.
  • The Commission delegated regulation precludes particles that are not in a solid state, such as micelles, liposomes, or nanoscale droplets in emulsion, and ingredients containing less than 50 % of particles less than 100 nm in size from being considered as nanomaterials in food.
  • The proposed default threshold value of 50 % or more particles at the nanoscale is arbitrary and less protective than the interpretation that has been given by some Member States, for example France of the definition in Regulation (EU) 2015/2283. That Regulation does not consider a size distribution threshold value for particles below 100 nm.
  • The proposed definition would potentially exclude many nano-substances from the scope of Regulation (EU) No 1169/2011, which would thus not be subject to the ‘[nano]’ labelling obligation.
  • The European Food Safety Authority recommended that in view of the current uncertainties over safety, a lower nanoparticle number threshold, e.g. 10 %, should be considered for food related applications instead of the currently proposed 50 % in the Recommendation.
  • However, according to the resolution, the nanoparticle number threshold of 50 % included in the horizontal ‘[nano]’ definition ‘is not based on sound scientific arguments’, and recommends setting a lower value for that threshold.
  • On this basis, Parliament objects to the Commission delegated regulation regretting that the proposed threshold of 50 % does not take into account technical and scientific progress.
docs/2
date
2024-04-24T00:00:00
docs
url: https://www.europarl.europa.eu/doceo/document/TA-9-2024-0316_EN.html title: T9-0316/2024
type
Text adopted by Parliament, single reading
body
EP
events/3/summary
  • The European Parliament decided by 388 votes to 188, with 47 abstentions, to object to the Commission delegated regulation amending Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods as regards the definition of ‘engineered nanomaterials’.
  • Definition
  • Taking into account the possibility of food consisting of engineered nanomaterials being a novel food, Regulation (EU) 2015/2283 provides for a definition of engineered nanomaterial. Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers refers to the definition of ‘engineered nanomaterials’, in order to inform consumers of the presence of engineered nanomaterials in food.
  • Regulation (EU) 2015/2283 empowers the Commission to adjust and adapt the definition of ‘engineered nanomaterials’ referred to therein to technical and scientific progress or to definitions agreed at international level, by means of delegated acts, for the purposes of achieving the objectives of that Regulation.
  • Contradictions with recommendations and new scientific advancements
  • The Commission delegated regulation aims to address interpretation issues stemming from the current definition by introducing objective elements to determine whether a nanomaterial is ‘engineered’ or not, such as through replacing ‘intentionally produced [material]’ with ‘manufactured’.
  • The Commission delegated regulation precludes particles that are not in a solid state, such as micelles, liposomes, or nanoscale droplets in emulsion, and ingredients containing less than 50 % of particles less than 100 nm in size from being considered as nanomaterials in food.
  • The proposed default threshold value of 50 % or more particles at the nanoscale is arbitrary and less protective than the interpretation that has been given by some Member States, for example France of the definition in Regulation (EU) 2015/2283. That Regulation does not consider a size distribution threshold value for particles below 100 nm.
  • The proposed definition would potentially exclude many nano-substances from the scope of Regulation (EU) No 1169/2011, which would thus not be subject to the ‘[nano]’ labelling obligation.
  • The European Food Safety Authority recommended that in view of the current uncertainties over safety, a lower nanoparticle number threshold, e.g. 10 %, should be considered for food related applications instead of the currently proposed 50 % in the Recommendation.
  • However, according to the resolution, the nanoparticle number threshold of 50 % included in the horizontal ‘[nano]’ definition ‘is not based on sound scientific arguments’, and recommends setting a lower value for that threshold.
  • On this basis, Parliament objects to the Commission delegated regulation regretting that the proposed threshold of 50 % does not take into account technical and scientific progress.
docs/2
date
2024-04-24T00:00:00
docs
url: https://www.europarl.europa.eu/doceo/document/TA-9-2024-0316_EN.html title: T9-0316/2024
type
Text adopted by Parliament, single reading
body
EP
events/3/summary
  • The European Parliament decided by 388 votes to 188, with 47 abstentions, to object to the Commission delegated regulation amending Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods as regards the definition of ‘engineered nanomaterials’.
  • Definition
  • Taking into account the possibility of food consisting of engineered nanomaterials being a novel food, Regulation (EU) 2015/2283 provides for a definition of engineered nanomaterial. Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers refers to the definition of ‘engineered nanomaterials’, in order to inform consumers of the presence of engineered nanomaterials in food.
  • Regulation (EU) 2015/2283 empowers the Commission to adjust and adapt the definition of ‘engineered nanomaterials’ referred to therein to technical and scientific progress or to definitions agreed at international level, by means of delegated acts, for the purposes of achieving the objectives of that Regulation.
  • Contradictions with recommendations and new scientific advancements
  • The Commission delegated regulation aims to address interpretation issues stemming from the current definition by introducing objective elements to determine whether a nanomaterial is ‘engineered’ or not, such as through replacing ‘intentionally produced [material]’ with ‘manufactured’.
  • The Commission delegated regulation precludes particles that are not in a solid state, such as micelles, liposomes, or nanoscale droplets in emulsion, and ingredients containing less than 50 % of particles less than 100 nm in size from being considered as nanomaterials in food.
  • The proposed default threshold value of 50 % or more particles at the nanoscale is arbitrary and less protective than the interpretation that has been given by some Member States, for example France of the definition in Regulation (EU) 2015/2283. That Regulation does not consider a size distribution threshold value for particles below 100 nm.
  • The proposed definition would potentially exclude many nano-substances from the scope of Regulation (EU) No 1169/2011, which would thus not be subject to the ‘[nano]’ labelling obligation.
  • The European Food Safety Authority recommended that in view of the current uncertainties over safety, a lower nanoparticle number threshold, e.g. 10 %, should be considered for food related applications instead of the currently proposed 50 % in the Recommendation.
  • However, according to the resolution, the nanoparticle number threshold of 50 % included in the horizontal ‘[nano]’ definition ‘is not based on sound scientific arguments’, and recommends setting a lower value for that threshold.
  • On this basis, Parliament objects to the Commission delegated regulation regretting that the proposed threshold of 50 % does not take into account technical and scientific progress.
docs/2
date
2024-04-24T00:00:00
docs
url: https://www.europarl.europa.eu/doceo/document/TA-9-2024-0316_EN.html title: T9-0316/2024
type
Text adopted by Parliament, single reading
body
EP
events/3/summary
  • The European Parliament decided by 388 votes to 188, with 47 abstentions, to object to the Commission delegated regulation amending Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods as regards the definition of ‘engineered nanomaterials’.
  • Definition
  • Taking into account the possibility of food consisting of engineered nanomaterials being a novel food, Regulation (EU) 2015/2283 provides for a definition of engineered nanomaterial. Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers refers to the definition of ‘engineered nanomaterials’, in order to inform consumers of the presence of engineered nanomaterials in food.
  • Regulation (EU) 2015/2283 empowers the Commission to adjust and adapt the definition of ‘engineered nanomaterials’ referred to therein to technical and scientific progress or to definitions agreed at international level, by means of delegated acts, for the purposes of achieving the objectives of that Regulation.
  • Contradictions with recommendations and new scientific advancements
  • The Commission delegated regulation aims to address interpretation issues stemming from the current definition by introducing objective elements to determine whether a nanomaterial is ‘engineered’ or not, such as through replacing ‘intentionally produced [material]’ with ‘manufactured’.
  • The Commission delegated regulation precludes particles that are not in a solid state, such as micelles, liposomes, or nanoscale droplets in emulsion, and ingredients containing less than 50 % of particles less than 100 nm in size from being considered as nanomaterials in food.
  • The proposed default threshold value of 50 % or more particles at the nanoscale is arbitrary and less protective than the interpretation that has been given by some Member States, for example France of the definition in Regulation (EU) 2015/2283. That Regulation does not consider a size distribution threshold value for particles below 100 nm.
  • The proposed definition would potentially exclude many nano-substances from the scope of Regulation (EU) No 1169/2011, which would thus not be subject to the ‘[nano]’ labelling obligation.
  • The European Food Safety Authority recommended that in view of the current uncertainties over safety, a lower nanoparticle number threshold, e.g. 10 %, should be considered for food related applications instead of the currently proposed 50 % in the Recommendation.
  • However, according to the resolution, the nanoparticle number threshold of 50 % included in the horizontal ‘[nano]’ definition ‘is not based on sound scientific arguments’, and recommends setting a lower value for that threshold.
  • On this basis, Parliament objects to the Commission delegated regulation regretting that the proposed threshold of 50 % does not take into account technical and scientific progress.
docs/2
date
2024-04-24T00:00:00
docs
url: https://www.europarl.europa.eu/doceo/document/TA-9-2024-0316_EN.html title: T9-0316/2024
type
Text adopted by Parliament, single reading
body
EP
events/3/summary
  • The European Parliament decided by 388 votes to 188, with 47 abstentions, to object to the Commission delegated regulation amending Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods as regards the definition of ‘engineered nanomaterials’.
  • Definition
  • Taking into account the possibility of food consisting of engineered nanomaterials being a novel food, Regulation (EU) 2015/2283 provides for a definition of engineered nanomaterial. Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers refers to the definition of ‘engineered nanomaterials’, in order to inform consumers of the presence of engineered nanomaterials in food.
  • Regulation (EU) 2015/2283 empowers the Commission to adjust and adapt the definition of ‘engineered nanomaterials’ referred to therein to technical and scientific progress or to definitions agreed at international level, by means of delegated acts, for the purposes of achieving the objectives of that Regulation.
  • Contradictions with recommendations and new scientific advancements
  • The Commission delegated regulation aims to address interpretation issues stemming from the current definition by introducing objective elements to determine whether a nanomaterial is ‘engineered’ or not, such as through replacing ‘intentionally produced [material]’ with ‘manufactured’.
  • The Commission delegated regulation precludes particles that are not in a solid state, such as micelles, liposomes, or nanoscale droplets in emulsion, and ingredients containing less than 50 % of particles less than 100 nm in size from being considered as nanomaterials in food.
  • The proposed default threshold value of 50 % or more particles at the nanoscale is arbitrary and less protective than the interpretation that has been given by some Member States, for example France of the definition in Regulation (EU) 2015/2283. That Regulation does not consider a size distribution threshold value for particles below 100 nm.
  • The proposed definition would potentially exclude many nano-substances from the scope of Regulation (EU) No 1169/2011, which would thus not be subject to the ‘[nano]’ labelling obligation.
  • The European Food Safety Authority recommended that in view of the current uncertainties over safety, a lower nanoparticle number threshold, e.g. 10 %, should be considered for food related applications instead of the currently proposed 50 % in the Recommendation.
  • However, according to the resolution, the nanoparticle number threshold of 50 % included in the horizontal ‘[nano]’ definition ‘is not based on sound scientific arguments’, and recommends setting a lower value for that threshold.
  • On this basis, Parliament objects to the Commission delegated regulation regretting that the proposed threshold of 50 % does not take into account technical and scientific progress.
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  • The European Parliament decided by 388 votes to 188, with 47 abstentions, to object to the Commission delegated regulation amending Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods as regards the definition of ‘engineered nanomaterials’.
  • Definition
  • Taking into account the possibility of food consisting of engineered nanomaterials being a novel food, Regulation (EU) 2015/2283 provides for a definition of engineered nanomaterial. Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers refers to the definition of ‘engineered nanomaterials’, in order to inform consumers of the presence of engineered nanomaterials in food.
  • Regulation (EU) 2015/2283 empowers the Commission to adjust and adapt the definition of ‘engineered nanomaterials’ referred to therein to technical and scientific progress or to definitions agreed at international level, by means of delegated acts, for the purposes of achieving the objectives of that Regulation.
  • Contradictions with recommendations and new scientific advancements
  • The Commission delegated regulation aims to address interpretation issues stemming from the current definition by introducing objective elements to determine whether a nanomaterial is ‘engineered’ or not, such as through replacing ‘intentionally produced [material]’ with ‘manufactured’.
  • The Commission delegated regulation precludes particles that are not in a solid state, such as micelles, liposomes, or nanoscale droplets in emulsion, and ingredients containing less than 50 % of particles less than 100 nm in size from being considered as nanomaterials in food.
  • The proposed default threshold value of 50 % or more particles at the nanoscale is arbitrary and less protective than the interpretation that has been given by some Member States, for example France of the definition in Regulation (EU) 2015/2283. That Regulation does not consider a size distribution threshold value for particles below 100 nm.
  • The proposed definition would potentially exclude many nano-substances from the scope of Regulation (EU) No 1169/2011, which would thus not be subject to the ‘[nano]’ labelling obligation.
  • The European Food Safety Authority recommended that in view of the current uncertainties over safety, a lower nanoparticle number threshold, e.g. 10 %, should be considered for food related applications instead of the currently proposed 50 % in the Recommendation.
  • However, according to the resolution, the nanoparticle number threshold of 50 % included in the horizontal ‘[nano]’ definition ‘is not based on sound scientific arguments’, and recommends setting a lower value for that threshold.
  • On this basis, Parliament objects to the Commission delegated regulation regretting that the proposed threshold of 50 % does not take into account technical and scientific progress.
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