BAKGRUNN (fra kommisjonsforordningen)

(1) Taking into account the possibility of food consisting of engineered nanomaterials being a novel food, Article 3(2), point (f), of Regulation (EU) 2015/2283 provides for a definition of engineered nanomaterial. Article 2(1), point (h), of Regulation (EU) No 1169/2011 of the European Parliament and of the Council refers to the definition of ‘engineered nanomaterials’ as established by point (f) of Article 3(2) of Regulation (EU) 2015/2283, in order to inform consumers of the presence of engineered nanomaterials in food. 

(2) On 10 June 2022, Commission Recommendation 2022/C 229/01 was adopted, updating the definition of nanomaterial set out in Commission Recommendation 2011/696/EU, in light of experience and technical and scientific progress. Recommendation 2022/C 229/01 takes into account the European Commission Joint Research Centre’s Science for Policy Reports “Towards a review of the EC Recommendation for a definition of the term “nanomaterial” Parts 1, 2, and 3 on the experience of stakeholders with the implementation of the definition and with the identification of possible points of revision, and two reports providing guidance on the implementation of the definition. It also takes into account relevant developments in standardisation by the International Organization for Standardization (ISO) and the European Committee for Standardisation (CEN), results of the NanoDefine project of the Commission’s 7th Framework Programme for Research, and the opinion of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) concerning the ‘Scientific basis for the definition of the term “Nanomaterial”. 

(3) It is therefore, appropriate to adapt the definition of engineered nanomaterial laid down in Regulation (EU) 2015/2283 taking into consideration Recommendation 2022/C 229/01, which reflects the latest technical and scientific updates in this area. 

(4) Experience with the current definition of engineered nanomaterial has shown difficulties in its implementation for both food business operators and enforcement authorities, as it allows for different interpretations as to whether a material is intentionally produced to be an engineered nanomaterial. The implementation of the current definition was hindered also by the lack of a default threshold value of particles with external dimensions in the nanoscale. It is therefore appropriate that the definition of engineered nanomaterial is adapted to include a default threshold of particles in the number-based size distribution with external dimensions in the nanoscale, present in a manufactured material, above which the material would be considered to have acquired specific functional properties and would therefore be considered as an engineered nanomaterial. 

(5) The technical and scientific elements underpinning the nanomaterial definition contained in Recommendation 2022/C 229/01 did not provide scientific evidence that the default threshold of 50% of particles with external dimensions at the nanoscale pursuant to Recommendation 2011/696/EU should be changed. It is therefore appropriate that this default threshold is included in the definition of engineered nanomaterial to ensure regulatory consistency and coherence, to avoid the possibility that a specific material could be considered a nanomaterial under one regulatory framework but not under another, and to provide objectivity and clarity in the implementation of the definition of engineered nanomaterial for the economic operators, consumers, and enforcement authorities. 

(6) Since the definition laid down in Regulation (EU) 2015/2283 refers to engineered nanomaterials and not to natural and/or incidental nanomaterials, only manufactured materials consisting of at least 50% of particles in the nanoscale should be included in that definition. 

(7) For the purposes of defining engineered nanomaterials, and to address the inherent subjectivity of the current definition in interpreting whether a material is intentionally produced to be an engineered nanomaterial or not, a description of the term ‘manufactured’ should be included in the definition to introduce existing objective technical elements that encompass the processes of manufacturing nanomaterials which are produced, synthesised or generated by physical/mechanical, and/or biological, and/or chemical processing, formulation and/or transformation of raw and/or starting materials. 

(8) The definition and its core terms should, where applicable, be based on existing scientifically defined and standardised terms adopted by the international communities (ISO, CEN). The core terms used in the definition should remain sufficiently specific and should enable the practical implementation of the definition within the context of Regulation (EU) 2015/2283. Its implementation should be supported, where applicable, by the guidance prepared by the European Commission Joint Research Centre (‘JRC’) in the context of the implementation of the definition in Recommendation 2022/C 229/01, by the guidance documents of the European Food Safety Authority (‘the Authority’) on the risk assessment of nanomaterials to be applied in the food and feed chain: human and animal health and on technical requirements for regulated food and feed applications to establish the presence of small particles including nanoparticles. These guidance documents may be further updated as a result of the evolving scientific and technical progress. 

(9) The definition of ‘engineered nanomaterial’ should cover both “particles on their own” and “identifiable constituent particles in agglomerates or aggregates”. The identification and measurement of constituent particles in agglomerates or aggregates can be very challenging. Thus, the 'identifiable' qualifier is bound by practical considerations pertaining to their identification. 

(10) The term ‘particle’ should be defined as a minute piece of matter with defined physical boundaries in line with the definition of ‘particle’ adopted in ISO 26824:2022. 

(11) As the external dimension of the constituent particles of a material is the only common feature of all nanomaterials, the definition of engineered nanomaterial should be based on the relative fraction of particles in a defined range within the particle number-based distribution of the external dimension of the constituent particles of a material. 

(12) A single molecule, including a macromolecule such as a protein that may be larger than 1 nm, should not be considered as a particle. In very specific cases, the distinction may depend on a precise understanding of the term ‘single molecule’. 

(13) Recommendation 2022/C 229/01 refers to materials consisting of particles in solid state. It is therefore appropriate that the definition of engineered nanomaterial would also refer to materials consisting of particles in solid state to exclude particles with highly dynamic external dimensions such as micelles, liposomes, or nanoscale droplets in emulsions. 

(14) The NanoDefine project demonstrated that, in a broad range of materials tested, there were no inconsistencies in classification of non-nanomaterials, based on the median value determined from the particle number-based size distributions and on the volume specific surface area being less than 6 m2 /cm3 (even if particle shape is unknown), respectively. Therefore, a material with a volume specific surface area less than 6 m2 /cm3 should not be considered a nanomaterial. 

(15) In its guidance documents on risk assessment of nanomaterials to be applied in the food and feed chain: human and animal health, and on technical requirements for regulated food and feed applications to establish the presence of small particles including nanoparticles, the Authority stated that materials should be also considered on the basis of their solubility and/or dissolution/degradation properties in water and not solely on the basis of their physical form. The Authority also identified flexible approaches, and the technical conditions that allow for a proper evaluation of the solubility and/or dissolution/degradation properties of materials in water and defined cut-off thresholds above which materials should not be considered to be nanomaterials. It is therefore appropriate that materials which exhibit solubility and/or dissolution/degradation properties in water, measured according to the approach and technical elements set out by the Authority guidance documents, above the thresholds established by the Authority, should not be considered engineered nanomaterials. 

(16) In order to provide business operators with sufficient time to comply with the requirements of this Regulation, the applicability of this Regulation should be deferred. Transitional measures for foods lawfully placed on the market and labelled before the date of application of this Regulation should be also provided in order to avoid any unnecessary food waste. Furthermore, a food lawfully placed on the market before the date of application of this Regulation and which falls within the scope of this Regulation, should in principle be allowed to continue to be placed on the market until the risk assessment and authorization procedures taking into account the definition laid down in this Regulation, have been concluded. The applications under Regulation (EU) 2015/2283 for foods falling within the scope of this Regulation for which a final decision has not been taken before the date of application of this Regulation, should be updated by the applicant in order to allow for appropriate risk assessment. Therefore, transitional provisions should be laid down to ensure a smooth transition to the application of the definition laid down in this Regulation.

(17) Regulation (EU) 2015/2283 should therefore be amended accordingly,