Abstract
Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of vitamin E in the forms of tocopherol extracts from vegetable oils, tocopherol‐rich extracts from vegetable oils (delta rich) and alpha‐tocopherol, as technological feed additives for all animal species. The additives are already authorised for use in all animal species without a specified minimum or maximum level. The applicant provided evidence that the additives currently on the market comply with the existing conditions of authorisation. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additives remain safe for the target species, the consumer and the environment. Regarding user safety, the additives should be considered skin and respiratory sensitisers. Exposure of users by inhalation and dermal routes is considered a risk. The FEEDAP Panel cannot conclude on the eye irritation potential due to the lack of data. There is no need to assess the efficacy of the additives in the context of the renewal of the authorisation.
Keywords: all animal species, antioxidant, efficacy, safety, technological additives, tocopherol
1. INTRODUCTION
1.1. Background and Terms of Reference
Regulation (EC) No 1831/2003 1 establishes the rules governing the Community authorisation of additives for use in animal nutrition. In particular, Article 14(1) of that Regulation lays down that an application for renewal shall be sent to the Commission at the latest 1 year before the expiry date of the authorisation.
The European Commission received a request from ADM International Sàrl represented in the EU by ADM speciality Ingredients (Europe) B.V., DSM Nutritional Products Ltd. represented in the EU by DSM Nutritional Products Sp. Z.o.o., Europe‐Asia Import Export GmbH, Vitiva d.o.o., Kaesler Nutrition GmbH, Kemin Nutrisurance Europe SRL, Lucta S.A. and Vitae Caps S.A.U (Kensing) 2 for the renewal of the authorisation of the additives tocopherol extracts from vegetable oils, tocopherol‐rich extracts from vegetable oils (delta rich) and alpha‐tocopherol, when used as feed additives for all animal species (category: technological additives; functional group: antioxidants).
According to Article 7(1) of Regulation (EC) No 1831/2003, the Commission forwarded the application to the European Food Safety Authority (EFSA) under Article 14(1) (renewal of the authorisation). The dossier was received on 31 July 2024 and the general information and supporting documentation are available at https://open.efsa.europa.eu/questions/EFSA‐Q‐2024‐00505. The particulars and documents in support of the application were considered valid by EFSA as of 12 September 2024.
According to Article 8 of Regulation (EC) No 1831/2003, EFSA, after verifying the particulars and documents submitted by the applicant, shall undertake an assessment in order to determine whether the feed additive complies with the conditions laid down in Article 5. EFSA shall deliver an opinion on the safety for the target animals, consumer, user and the environment and on the efficacy of the feed additives consisting of tocopherol extracts from vegetable oils, tocopherol‐rich extracts from vegetable oils (delta rich) and alpha‐tocopherol, when used under the proposed conditions of use (see Section 3.1.4 ).
1.2. Additional information
Tocopherols are currently authorised in the form of tocopherol extracts from vegetable oils (1b306(i)), tocopherol‐rich extracts from vegetable oils (delta rich) (1b306(ii)) and alpha‐tocopherol (1b307) for use in feed for all animal species. 3
EFSA issued two opinions on the safety and efficacy of these products when used in feed for all animal species as antioxidant (EFSA FEEDAP Panel, 2012a,b).
2. DATA AND METHODOLOGIES
2.1. Data
The present assessment is based on data submitted by the applicant in the form of a technical dossier 4 in support of the authorisation request for the use of vitamin E in the form of tocopherol extracts from vegetable oils, tocopherol‐rich extracts from vegetable oils (delta rich) and alpha‐tocopherol as a feed additive.
In accordance with Article 38 of the Regulation (EC) No 178/2002 5 and taking into account the protection of confidential information and of personal data in accordance with Articles 39 to 39e of the same Regulation, and of the Decision of EFSA's Executive Director laying down practical arrangements concerning transparency and confidentiality, 6 a non‐confidential version of the dossier has been published on Open.EFSA.
According to Article 32c(2) of Regulation (EC) No 178/2002 and to the Decision of EFSA's Executive Director laying down the practical arrangements on pre‐submission phase and public consultations, EFSA carried out a public consultation on the non‐confidential version of the technical dossier from 28 January to 18 February 2025 for which no comments were received.
The confidential version of the technical dossier was subject to a target consultation of the interested Member States from 18 September 2024 to 18 December 2024; the comments received were considered for the assessment.
The FEEDAP Panel used the data provided by the applicant together with data from other sources, such as previous risk assessments by EFSA or other expert bodies, peer‐reviewed scientific papers, other scientific reports and experts' knowledge, to deliver the present output.
The European Union Reference Laboratory (EURL) considered that the conclusions and recommendations reached in the previous assessment regarding the methods used for the control of the tocopherol extracts from vegetable oils, tocopherol‐rich extracts from vegetable oils (delta rich) and alpha‐tocopherol in animal feed are valid and applicable for the current application. 7
2.2. Methodologies
The approach followed by the FEEDAP Panel to assess the safety and the efficacy of vitamin E in the form of tocopherol extracts from vegetable oils, tocopherol‐rich extracts from vegetable oils (delta rich) and alpha‐tocopherol is in line with the principles laid down in Regulation (EC) No 429/2008 8 and the relevant guidance documents: Guidance on the renewal of the authorisation of feed additives (EFSA FEEDAP Panel, 2021).
3. ASSESSMENT
The additives tocopherol extracts from vegetable oils (1b306(i)), tocopherol‐rich extracts from vegetable oils (delta rich) (1b306(ii)) and alpha‐tocopherol (1b307) are currently authorised as technological additives (functional group: antioxidants) for use in feed for all animal species. 9
The authorisation also states that tocopherol extracts from vegetable oils, tocopherol‐rich extracts from vegetable oils (delta rich) and alpha‐tocopherol may be placed on the market and used as additives consisting of a preparation. The applicants indicated that with the present application, they are seeking the renewal of the authorisation for tocopherol extracts from vegetable oils (≥ 30% total tocopherol), tocopherol‐rich extracts from vegetable oils (delta rich) (≥ 80% total tocopherol, ≥ 70% delta‐tocopherol) and alpha‐tocopherol (≥ 96%) posed of the active substance only. The applicants stated that the renewal application does not cover the use of preparations.
The data supporting the application for tocopherol extracts from vegetable oils were generated by six companies while the data supporting the application for tocopherol‐rich extracts from vegetable oils (delta rich) and alpha‐tocopherol were submitted by two companies.
3.1. Characterisation
3.1.1. Tocopherol extracts from vegetable oils
Tocopherol extracts from vegetable oils (1b306(i)) are liquid oily extracts of natural origin and consist of a mixture of alpha‐tocopherol (molecular formula C29H50O2, Chemical Abstract Service (CAS) No. 59‐02‐9, European Commission (EC) No. 200‐412‐2), beta‐tocopherol (molecular formula C28H48O2, CAS No. 16698‐35‐4), 10 gamma‐tocopherol (molecular formula C28H48O2, CAS No. 54‐28‐4, EC No. 200‐201‐5) and delta‐tocopherol (molecular formula C27H46O2, CAS No. 119‐13‐1, EC No. 204‐299‐0). Tocopherol extracts from vegetable oils are currently authorised with a minimum content of 30% total tocopherols (alpha‐, beta‐, gamma‐ and delta‐tocopherols). The applicants state that no changes have been introduced in the manufacturing process or in the composition since the last authorisation.
The applicants described different products, all complying with the authorised specifications (minimum 30% total tocopherols), with minimum contents of 50%, 70% or ≥ 90% total tocopherols (alpha‐, beta‐, gamma‐ and delta‐tocopherols). The data provided by the applicants on the batch‐to‐batch variation 11 and residual solvents 12 of the additive are reported in Table 1.
TABLE 1.
Data on the batch‐to‐batch variation and residual solvents of tocopherol extracts from vegetable oils. The data presented are average values and (range) for batch‐to‐batch variation, and ranges for all other parameters. The number of batches analysed per parameter or group of parameters are indicated in [].
| Company | A | D | E | F | G | H | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Specifications 1 | |||||||||||
| Total tocopherols (alpha‐, beta‐, gamma‐ and delta‐tocopherol) (%) | ≥ 30 | ||||||||||
| ≥ 50% | ≥ 70% | ≥ 90% | ≥ 70% | ≥ 50% | ≥ 70% | ≥ 90% | ≥ 50% | ≥ 90% | ≥ 50% | ≥ 70% | |
| Batch‐to‐batch variation (%), [] * | [5] | [6] | [6] | [5] | [5] | [5] | [5] | [4] | [3] | [5] | [5] |
| Total tocopherols | 54.6 (53.6–56.6) | 72.3 (71.3–73.7) | 93.7 (92.6–95.5) | 71 (70–73) | 50.7 (50.6–50.9) | 71.3 (70.1–76.9) [8] | 90.9 (90.6–91.5) | 50.4 (50.2–50.6) [5] | 90.6 (90.2–91.3) [7] | 50.5 (50.3–50.9) | 72.2 (71.2–72.6) |
| Alpha‐tocopherol | 7.92 (6–9.6) | 8 (1.23–9.9) | 12.9 (9.3–15.2) | – | 10.2 (9.9–10.5) | 11.9 (10.4–12.0) | 10.4 (9.9–10.8) | 9.39 (9.28–9.62) | 87.3 (85.1–90.4) [7] | 16.3 (14.5–17.9) | 16.22 (12.8–17.8) |
| Beta‐tocopherol | 1.1 (1–1.3) | 1.38 (1–1.8) | 1.76 (1.6–2.4) | – | 0.94 (0.9–1.02) | 1.29 (0.97–1.5) | 1.62 (1.5–1.7) | 0.81 (0.79–0.85) | 16.6 (10.4–13.6) | 2.28 [1] | 2.46 (2.2–3.0) |
| Gamma‐tocopherol | 32.1 (31.6–32.5) | 44.4 (42.3–47.3) | 63.8 (61.2–66.3) | – | 30.6 (30.1–31.2) | 46.3 (44.3–47.6) | 55.96 (55.4–57.2) | 31.21 (30.9–31.4) | 1.73 (1.65–1.81) | 56.96 [1] | 60.1 (58.1–62.4) |
| Delta‐tocopherol | 13.44 (12.1–14.4) | 16.8 (16.0–19.0) | 15.2 (13.7 + 19.1) | – | 9.2 (8.51–9.64) | 10.9 (9.13–14.8) | 22.9 (21.2–23.6) | 9.06 (8.9–9.3) | 55.7 (55.2–56.5) | 21.7 (20.7–22.8) | 21.3 (17.5–25.8) |
| Residual solvents (mg/kg), [] * | [1] | [4] | [4] | [3] | [3] | [3] | [3] | [5] | [1] | [2] | |
| Methyl alcohol | – | – | – | – | < 10 | < 10 | < 10 | – | < 20 [4] | 171 | < 10 |
| n‐Hexane | – | – | – | – | < 2.5 | < 2.5 | ‐ | < 1 [2] | – | – | < 1 |
| Heptane | – | – | – | – | – | – | – | – | – | 153 | – |
| Ethanol | < 0.1 | < 0.1 | < 0.1 | – | < 2.5–2.7 | < 2.5 | < 10 | < 10–4.19 | < 1–< 10 2 | – | < 10 [1] |
| Physical form | Oil | Oil | Oil | Oil | Oil | Oil | Oil | Oil | Oil | Oil | Oil |
Note: <: means below the limit of quantification. –: not analysed.
Specifications set in Regulation (EU) No 2025/1152.
Two methods with a different limit of quantification were applied.
Number of batches analysed per group of parameters, unless otherwise indicated.
The applicant provided multiresidue analyses of pesticides (data not shown). Data on other impurities 13 are reported in Appendix A.
No new data has been submitted regarding the physico‐chemical properties of the additive. Considering that the manufacturing process and the composition of the additive have not been modified, the FEEDAP Panel considers that the conclusions reached in the previous opinion still apply (EFSA FEEDAP Panel, 2012a,b).
The data provided by the applicant showed compliance with the specifications set in the authorising regulation for total tocopherols (alpha‐, beta‐, gamma‐ and delta‐tocopherols).
The Panel considers that the levels of the impurities analysed are of no concern, except for zearalenone levels analysed by Company F for the product containing tocopherol at ≥ 90% (Table A1, Appendix A). The FEEDAP Panel noted that the levels measured are above the guidance values recommended by the EC. 14 The levels of the residual solvents are below the VICH limits (EMA CVMP, 2023).
3.1.2. Tocopherol‐rich extracts from vegetable oils (delta rich)
Tocopherol‐rich extracts from vegetable oils (delta rich) (1b306(ii)) are liquid oily extracts of natural origin and consist of a mixture of alpha‐tocopherol (molecular formula C29H50O2, CAS No. 59‐02‐9), beta‐tocopherol (molecular formula C28H48O2, CAS No. 16698‐35‐4), 15 gamma‐tocopherol (molecular formula C28H48O2, CAS No. 54‐28‐4) and delta‐tocopherol (molecular formula C27H46O2, CAS No. 119‐13‐1). Tocopherol extracts from vegetable oils are currently authorised for use as feed additive with a minimum content of 80% total tocopherols (alpha‐, beta‐, gamma‐ and delta‐tocopherols) with a minimum of 70% delta‐tocopherol. The applicants state that no changes have been introduced in the manufacturing process or in the composition since the last authorisation.
The data provided by the applicants on the batch‐to‐batch variation 16 and residual solvents 17 of the additive are reported in Table 2. Data on impurities 18 and other parameters is reported in Appendix B.
TABLE 2.
Data on the batch‐to‐batch variation and residual solvents of tocopherol‐rich extracts from vegetable oils (delta rich). The data presented are average values and (range) for batch‐to‐batch variation, and ranges for all other parameters. The number of batches analysed per parameter or group of parameters are indicated in [].
| Company | E | F |
|---|---|---|
| Specifications 1 | ||
| Total tocopherols (alpha‐, beta‐, gamma‐ and delta‐tocopherols) (%) | ≥ 80 | |
| Delta‐tocopherol (%) | ≥ 70 | |
| Batch‐to‐batch variation (%), [] * | [5] | [7] |
| Total tocopherols | 82.7 (80.4–84.07) [8] | 81.4 (80.9–82.1) |
| Delta‐tocopherol | 70.84 (70.77–70.9) | 72.1 (71.5–72.6) |
| Alpha‐tocopherol | 0.76 (0.68–0.83) | 1.1 (0.8–1.4) |
| Gamma‐tocopherol | 12.44 (12.37–12.53) | 8.2 (7.8–8.8) |
| Residual solvents (mg/kg) | [3] | [3] |
| Ethanol | < 10 | < 1 |
| Methanol | < 10 | 1.03–1.27 |
| Physical form | Oil | Oil |
Note: <: means below the limit of quantification.
Specifications set in Regulation (EU) No 2015/1152.
Number of batches analysed per group of parameters, unless otherwise indicated.
No new data has been submitted regarding the physico‐chemical properties of the additive. Considering that the manufacturing process and the composition of the additive have not been modified, the FEEDAP Panel considers that the conclusions reached in the previous opinion still apply (EFSA FEEDAP Panel, 2012a,b).
The data provided by the applicant showed compliance with the specifications set in the authorising regulation for total tocopherols (alpha‐, beta‐, gamma‐ and delta‐tocopherols) and delta‐tocopherol. The Panel considers that the levels of the impurities analysed (Table B1, Appendix B) are of no concern. The levels of the residual solvents are below the VICH limits (EMA CVMP, 2023).
3.1.3. Alpha‐tocopherol
Alpha‐Tocopherol (all‐rac‐alpha‐tocopherol) (1b307) is an oily liquid synthetically produced, and its molecular formula is C29H50O2 and the CAS No. is 10191‐41‐0. It is currently authorised with a purity of a minimum of 96%. The applicants state that no changes have been introduced in the manufacturing process or in the composition since the last authorisation.
The data provided by the applicants on the batch‐to‐batch variation 19 and residual solvents 20 of the additive are reported in Table 3. Data on impurities and other parameters 21 are reported in Appendix C.
TABLE 3.
Data on the batch‐to‐batch variation and impurities of alpha‐tocopherol. The data presented are average values and (range) for batch‐to‐batch variation, and ranges for all other parameters. The number of batches analysed, or group of parameters are indicated in [].
| Company | B | C |
|---|---|---|
| Specifications 1 | ||
| Alpha‐tocopherol (%) | ≥ 96 | |
| Batch‐to‐batch variation (%), [] * | [7] | [7] |
| Alpha‐tocopherol | 99.3 (98.7–99.6) | 100.2 (99.8–100.4) |
| Loss on drying | – | 0.053 (0.05–0.06) [3] |
| Sulphated ash | < 0.1 [4] | – |
| Residual solvents (mg/kg) | [4] | [3] |
| Benzene | < 2 | – |
| Toluene | < 20 | – |
| Diethyl carbonate | – | < 5 |
| Physical form | Oil | Oil |
Note: <: means below the limit of quantification. –: not analysed.
Specifications set in Regulation (EU) No 2015/1152.
Number of batches analysed per group of parameters, unless indicated.
No new data has been submitted regarding the physico‐chemical properties of the additive. Considering that the manufacturing process and the composition of the additive have not been modified, the FEEDAP Panel considers that the conclusions reached in the previous opinion still apply (EFSA FEEDAP Panel, 2012a,b).
The data provided by the applicant showed compliance with the specifications set in the authorising regulation for the active substance alpha‐tocopherol. The Panel considers that the levels of the impurities analysed (Table C1, Appendix C) are of no concern. The levels of the residual solvents are below the VICH limits (EMA CVMP, 2023).
3.1.4. Conditions of use
The additives are currently authorised for use in feed for all animal species without a specified minimum or maximum level.
Under ‘other provisions’, it is stated:
Tocopherol extracts from vegetable oils/Tocopherol‐rich extracts from vegetable oils (delta rich)/Alpha‐tocopherol may be placed on the market and used as an additive consisting of a preparation.
In the directions for use of the additive, indicate the storage and stability conditions, and for the premixtures, the storage conditions.
The applicant did not request any changes in the current conditions of authorisation.
3.2. Safety
The safety of vitamin E in the form of tocopherol extracts from vegetable oils, tocopherol‐rich extracts from vegetable oils (delta rich) and alpha‐tocopherol, was evaluated in previous opinions in which no safety concerns were expected for target species, the consumer, the users and the environment.
For the current assessment, the applicant declared that no incidents or safety issues for the target species, consumers, users and the environment have been documented or reported regarding the additives since their authorisation. 22
In addition, the applicant conducted a literature search to identify any new available information since the previous assessment.
3.2.1. Literature search
In support of the safety of the additive, the applicants submitted the results of three literature searches performed in accordance with the requirements of the Guidance on the renewal of the authorisation of feed additives (EFSA FEEDAP Panel, 2021). The first search period covered the period from 2014 to 2024, the second from 2012 to 2014 and the third from 2012 to 2024. 23
Several databases and platforms were used (e.g. LIVIVO, OVID, PubMed, Springer, Elsevier, MDPI, Ingenta, Kluwer/LWW). For the third search, Google Scholar was applied. A total of 101 references were selected by the applicants as relevant for the current assessment. A total of, 35 papers were related to the safety for the target species, 42 on the safety for the consumers, 13 on the safety for the users and one paper on the environment were found. All the papers were reviewed, and the FEEDAP Panel considered that none of them reported new information related to safety for the target species, consumer and user that would change the conclusions previously reached.
3.2.2. Safety for the target species and the environment
Considering that the manufacturing process and the composition of the additive have not been modified since the previous authorisation and no relevant new information was found in the literature search, the Panel concludes that the additives remain safe for the target species and the environment under the current conditions of the authorisation.
3.2.3. Safety for the consumer
3.2.3.1. Reassessment of the consumer exposure
In 2003, the Scientific Committee on Food (SCF) established a tolerable upper intake level (UL) for vitamin E for adults as 300 mg/day (European Commission, 2003). Based on the body weight (bw), the UL for children (1–3 years) and adolescents was set at 100 and 260 mg/day, respectively.
More recently, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) revised the UL for vitamin E and considered that the ULs, which were previously established by the SCF, can be retained for all population groups, i.e. 300 mg/day for adults (including pregnant and lactating women), 100 mg/day for children aged 1–3 years, 120 mg/day for 4–6 years, 160 mg/day for 7–10 years, 220 mg/day for 11–14 years and 260 mg/day for 15–17 years. In addition, ULs of 50 and 60 mg/day have been newly established for infants aged 4–6 months and for infants aged 7–11 months, respectively (EFSA NDA Panel, 2024).
In the previous FEEDAP Panel opinion (EFSA FEEDAP Panel, 2010), a ‘worst‐case scenario’ exposure assessment for the consumer, based on the consumption model described in Regulation (EC) No 429/2008 and on data from literature on vitamin E content in edible tissues and products from animals treated with vitamin E at levels far higher than the practical use (1000 mg/kg feed), indicated that the theoretical exposure of consumers amounted to about 45% of the UL (300 mg alpha‐tocopherol equivalents/day).
In more recent assessments of consumer exposure to vitamin E used as nutritional additive in all animal species (EFSA FEEDAP Panel, 2021b, 2021c, 2021d, 2021e), the FEEDAP Panel performed an updated exposure assessment following the methodology described in the Guidance on consumer safety (EFSA FEEDAP Panel, 2017), using literature residue data provided by the applicant (Kidane et al., 2015; Ouraji et al., 2011; Song et al., 2014) and some residue data already available for the 2010 assessment. The FEEDAP Panel considered that the contribution to the consumer exposure to vitamin E from products of animals fed with the additive ranged from 9.5% (in ‘adults’) to 15.3% (in ‘other children’) of the ULs.
In the current assessment, no new papers were retrieved by the applicants, from the literature searches conducted, that would lead to a change of the conclusions previously reached on the consumer exposure assessment and safety (EFSA FEEDAP Panel, 2021b, 2021c, 2021d, 2021e).
However, considering the new establishment of ULs for infants aged 4–6 months and for infants aged 7–11 months, the FEEDAP Panel recalculated the exposure assessment for the population category ‘infants 4–12 months’, following the methodology described in the Guidance on consumer safety (EFSA FEEDAP Panel, 2017) and using the same residue data used the previous assessments (EFSA FEEDAP Panel, 2021b, 2021c, 2021d, 2021e). The highest reliable percentile (HRP) calculated for the population category ‘Infants 4–12 months’ was 0.43 mg vitamin E/kg bw per day which would correspond to 3.5 mg vitamin E/day, considering an average bw of 7.9 kg. 24 The contribution to the consumer exposure to vitamin E from products of animals fed with the additive for the population category ‘Infants 7–11 months’ is 5.8% of the UL (60 mg/day).
3.2.3.2. Conclusions on safety for the consumer
The FEEDAP Panel concludes that there is no safety concern for the consumer resulting from the intake of food from all animal species fed with vitamin E in the form of tocopherol extracts from vegetable oils, tocopherol‐rich extracts from vegetable oils (delta rich) and alpha‐tocopherol under the conditions of the existing authorisation.
3.2.4. Safety for the users
In the previous assessments, the Panel concluded that no safety concern is expected from the use of the active substances in feed additives.
For the current assessment, no data in support of the safety for the users was submitted.
Based on the information present in the safety data sheet, the additives are dermal and respiratory sensitisers. 25
The additives should be considered skin and respiratory sensitisers. Exposure of users by inhalation and dermal routes is considered a risk. The FEEDAP Panel cannot conclude on the eye irritation potential due to the lack of data.
3.3. Efficacy
The present application for renewal of the authorisation does not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additive. Therefore, there is no need for assessing the efficacy of the additives in the context of the renewal of the authorisation.
4. CONCLUSIONS
The applicants provided evidence that the additives currently in the market comply with the existing conditions of the authorisation.
The FEEDAP Panel concludes that the use of vitamin E in the form of tocopherol extracts from vegetable oils, tocopherol‐rich extracts from vegetable oils (delta rich) and alpha‐tocopherol under the current authorised conditions remains safe for the target species, the consumers and the environment.
The additives should be considered skin and respiratory sensitisers. Exposure of users by inhalation and dermal routes is considered a risk. The FEEDAP Panel cannot conclude on the eye irritation potential due to the lack of data.
There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.
5. RECOMMENDATIONS
The FEEDAP Panel notes that the values found for zearalenone analysed by Company F for tocopherol extracts from vegetable oils containing tocopherol at ≥ 90% (Appendix A) are high and deserve attention/monitoring during the production process.
ABBREVIATIONS
- BW
body weight
- CAS
Chemical Abstracts Service
- CFU
colony forming unit
- DM
dry matter
- EURL
European Union Reference Laboratory
- FEEDAP
EFSA Scientific Panel on Additives and Products or Substances used in Animal Feed
- HRP
highest reliable percentile
- LOD
limit of detection
- LOQ
limit of quantification
- MNP
most probable number
- MW
molecular weight
- NDA
EFSA Panel on Nutrition, Novel Foods and Food Allergens
- nDL‐PCBs
non‐dioxin‐like PCBs
- PCBs
polychlorinated biphenyls
- PCDDs
polychlorinated dibenzo‐p‐dioxins
- PCDFs
polychlorinated dibenzofurans
- SCF
Scientific Committee on Food
- TEQ
toxic equivalent factors
- UL
tolerable upper intake level
- WHO
World Health Organization
REQUESTOR
European Commission
QUESTION NUMBER
EFSA‐Q‐2024‐00505
COPYRIGHT FOR NON‐EFSA CONTENT
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PANEL MEMBERS
Roberto Edoardo Villa, Giovanna Azimonti, Eleftherios Bonos, Henrik Christensen, Mojca Durjava, Birgit Dusemund, Ronette Gehring, Boet Glandorf, Maryline Kouba, Marta López‐Alonso, Francesca Marcon, Carlo Nebbia, Alena Pechová, Miguel Prieto‐Maradona and Katerina Theodoridou.
ACKNOWLEDGEMENTS
The Panel wishes to thank the following for the support provided to this scientific output: Laura Iancu.
APPENDIX A.
TABLE A1.
Data on the impurities and physical properties of tocopherol extracts from vegetable oils. The data presented are ranges for all parameters. The number of batches analysed per parameter or group of parameters are indicated in [].
| Company | A | D | E | F | G | H | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Impurities [] * | |||||||||||
| Elemental impurities (μg/kg) | [1] | [4] | [4] | [4] | [2] | [3] | [3] | [4] | [6] | [3] | [5] |
| Arsenic | < 10 | < 10–22 | < 10–14.9 | < 2 | < 5–6.8 | < 5 | < 5 | < 10–< 30 1 | < 10–< 10,000 1 | < 10,000 | < 0.005–0.012 |
| Cadmium | < 5 | < 5 | < 5 | < 1 | < 5 | < 3–5.4 | < 3 | < 5–< 100 1 | < 5–< 20 1 | < 0.01 | < 0.005 |
| Lead | < 5 | < 5 | < 0.02–5 | < 5 | < 5 | < 5 | < 5 | < 4–< 10 1 | < 5–< 100 1 | < 0.05 | < 5–14 |
| Mercury | < 5 | < 5 | < 0.01–5 | < 0.1 | < 3 | < 3 | < 3 | < 5–< 10 1 | < 3–< 10 1 | < 0.005 | < 0.005 |
| Polycyclic aromatic hydrocarbons (PAHs) (μg/kg) | [3] | [4] | [3] | [5] | [3] | [5] | [5] | ||||
| Benzo(a)pyrene | – | – | – | < 0.05–0.8 | < 1–< 2 1 | < 0.5 | < 0.5 | < 1 | < 0.625–< 1 | – | < 0.4–0.6 |
| Sum of four PAHs (PAH4) 2 | – | – | – | < 0.05–3.8 | 4 [1] | – | – | 1.6–4.0 | < 1–5.7 | – | < 0.4–5.3 |
| Dioxins and furans (upper bound) 3 | [1] | [5] | [4] | [4] | [3] | [2] | [3] | [7] | [4] | [3] | [3] |
| PCDD/Fs (ng WHO2005‐TEQ/kg) | 0.659 | 0.302–0.88 | 0.284–0.571 | 0.331–0.323 | 0.14 | 0.318–0.346 | 0.135–0.137 | 0.137–0.59 | 0.078–0.093 | 0.85–1.01 | 0.158–0.166 |
| PCDD/Fs + PCBs (ng WHO2005‐TEQ/kg) | 0.805 | 0.467–1.06 | 0.454–0.771 | 0.529–0.538 | 0.272 | 0.509–0.551 | 0.204–0.207 | 0.271–1.14 | 0.088–0.269 | 1.38–1.47 | 0.271–0.306 |
| nDL‐PCBs (μg/kg) | 1.41 | 1.43–1.75 | 1.62–1.74 | 1.88–1.93 | 3 | 1.85–1.97 | 1.47–1.48 | 1.82–6.0 | 0.06–3.0 | 2.27–2.57 | 0.60–1.0 |
| Mycotoxins (μg/kg) | [1] | [4] | [4] | [3] | [1] | [5] | [3] | [5] | [2] | [3] | |
| Aflatoxins B1, B2, G1 and G2 (individually and sum) (μg/kg) | < 5 | < 5 | < 5 | < 0.05 | < 1 | < 0.1 | < 0.01 | < 1 |
< 1 [3] < 0.5 [1] < 0.3 [1] |
< 1 | < 0.05 |
| Fumonisin B1, B2 (individual) | – | – | – | < 10 | – | – | < 20 | < 10 [1] | – | – | – |
| Zearalenone | – | – | – | < 5 | – | – | 130–150 | – | 113–4400 [2] | – | – |
| Alpha‐zearalenol | – | – | – | < 5 | – | – | – | – | – | – | – |
| Beta‐zearalenol | – | – | – | < 5 | – | – | – | – | – | – | – |
| Ochratoxin A | – | – | – | < 0.1 | – | – | < 10 | – | – | – | – |
| Deoxynivalenol | – | – | – | < 5 | – | – | < 20 | < 5 [1] | – | – | – |
| HT‐2 Toxin | – | – | – | < 5 | – | – | < 1 | – | – | – | – |
| T‐2 Toxin | – | – | – | < 5 | – | – | < 3 | – | – | – | – |
| Microbial contamination [] * | [4] | [2] | [3] | [1] | [3] | [4] | [3] | [2] | |||
| Salmonella spp. (per 25g) | – | – | – | n.d. | n.d. | n.d. | n.d. |
n.d. [3] < 100 [1] |
n.d. [6] | n.d. | n.d. |
| Enterobacteriaceae (CFU/g) | – | – | < 10 | – | – | – | < 10 | < 10 [6] | < 10 | < 10 [2] | |
| Bacillus cereus (CFU/g) | – | – | – | < 10 | – | – | – | – | – | – | – |
| Shigella (per 25g) | – | – | – | – | – | – | n.d. | – | – | – | n.d. |
| Clostridium perfringens (CFU/g) | – | – | – | – | – | – | – | – | – | < 10 | |
| Staphilococcus aureus (per 25g) | – | – | – | – | n.d. | n.d. | n.d. | – | n.d. (in 10g) | – | – |
| Escherichia coli (CFU/g) | – | – | – | n.d. | – | – | – | < 10 [2] | < 10 | – | < 10 |
| Coliforms (MNP/g) | – | – | – | < 10 | < 10 | < 10 | < 10 | – | – | – | – |
| Yeast and moulds (CFU/g) | – | – | – | < 100 | < 10 | < 10 | < 10 | < 10 | < 10 | < 10 | < 10 [3] |
| Total plate count (CFU/g) | – | – | – | < 1000 | < 10 | < 10 | < 10 | < 10 [2] | < 10 | < 10 | < 10 |
| Physical properties | [5] | [8] | [5] | [5] | [7] | [5] | [5] | ||||
| Optical rotation (°) | – | – | – | – | 25.1 (21.9–26.6) | 30.4 (21.0–47.2) | 22.5 (20.9–23.4) | 23.1 (20.5–26.6) | 25.3 (23.7–28.0) | – | – |
| Specific gravidity (kg/m3) | – | – | – | – | – | – | – | – | – | 945 | 950 |
Note: <: means below the limit of quantification. –: not analysed. n.d.: not detected.
Abbreviations: CFU, colony forming unit; MNP, most probable number; nDL‐PCBs, non‐dioxin‐like PCBs; PCBs, polychlorinated biphenyls; PCDDs, polychlorinated dibenzo‐p‐dioxins; PCDFs, polychlorinated dibenzofurans; TEQ, toxic equivalent factors for dioxins, furans and dioxin‐like PCBs established by WHO in 2005 (Van den Berg et al., 2006); WHO, World Health Organization.
Two methods with a different limit of quantification were applied.
PAH4: Sum of benzo(a)pyrene, benzo(a)anthracene, benzo(b)fluoranthene and chrysene.
Upper bound concentrations are calculated on the assumption that all values of the different congeners below the limit of quantification are equal to the limit of quantification. Values are expressed per kg of additive with 88% dry matter content.
Number of batches analysed per group of parameters, unless otherwise indicated.
APPENDIX B.
TABLE B1.
Data on the impurities and physical properties of tocopherol‐rich extracts from vegetable oils (delta rich). The data presented are ranges for all parameters. The number of batches analysed per parameter or group of parameters are indicated in [].
| Company E | Company F | |
|---|---|---|
| Impurities [] * | ||
| Elemental impurities (mg/kg) | [3] | [3] |
| Arsenic | < 0.01 | < 0.01 |
| Cadmium | < 0.04 | < 0.05 |
| Lead | < 0.05 | < 0.05 |
| Mercury | < 0.03 | < 0.05 |
| Polycyclic aromatic hydrocarbons (PAHs) (μg/kg) | [3] | [3] |
| Benzo(a)pyrene | < 0 | < 2–1 |
| Benzo(a)anthracene | – | < 2 |
| Benzo(b)fluoranthene | – | < 2 |
| Benzo(k)fluoranthene | – | < 2 |
| Indeno(1,2,3‐cd)pyrene | – | < 2 |
| Dibenzo(a,h)anthracene | – | < 2 |
| Benzo(g,h,i)perylene | – | < 2 |
| Benzo(e)pyrene | – | < 2 |
| Chrysene | – | < 2 |
| Sum of 8 PAH | – | < 2 |
| Dioxins and furans (upper bound) 1 | [3] | [4] |
| PCDD/Fs (ng WHO2005‐TEQ/kg) | < 0.137–0.359 | 0.07–0.184 |
| PCDD/Fs + PCBs (ng WHO2005‐TEQ/kg) | < 0.269–0.619 | 0.076–0.192 |
| nDL‐PCBs (μg/kg) | 3 | 0.05–0.429 |
| Mycotoxins (μg/kg) | [1] | |
| Aflatoxins B1, B2, G1, G2 (individually and sum) | – | < 1 [3] |
| Fumonisins B1, B2 (individual) | < 20 | |
| Deoxynivalenol | – | < 40 |
| HT‐2 Toxin | – | < 10 |
| T‐2 Toxin | – | < 5 |
| Microbial contamination, [] * | [3] | [2] |
| Salmonella spp. (per 25g) | n.d. | n.d. [3] |
| Staphylococcus aureus (per 25g) | n.d. | – |
| Enterobacteriaceae (CFU/g) | – | < 10 |
| Listeria monocytogenes (per 25g) | – | n.d. [1] |
| Escherichia coli (CFU/g) | – | < 10 |
| Coliforms (MNP/g) | < 10 | < 10 [1] |
| Yeast and moulds (CFU/g) | < 10 | < 10 [3] |
| Total aerobic counts (CFU/g) | < 10 | < 10 |
| Physical properties | [3] | [7] |
| Optical rotation (°) | 27.7–28.1 | 24.3–27.3 |
Note: <: means below the limit of quantification. –: not analysed. n.d.: not detected.
Abbreviations: CFU, colony forming unit; MNP, most probable number; nDL‐PCBs, non‐dioxin‐like PCBs; PCBs, polychlorinated biphenyls; PCDDs, polychlorinated dibenzo‐p‐dioxins; PCDFs, polychlorinated dibenzofurans; TEQ, toxic equivalent factors for dioxins, furans and dioxin‐like PCBs established by WHO in 2005 (Van den Berg et al., 2006); WHO, World Health Organization.
Number of batches analysed per group of parameters, unless otherwise indicated.
Upper bound concentrations are calculated on the assumption that all values of the different congeners below the limit of quantification are equal to the limit of quantification. Values are expressed per kg of additive with 88% dry matter content.
APPENDIX C.
TABLE C1.
Data on impurities and physical properties of alpha‐tocopherol. The data presented are ranges for all parameters. The number of batches analysed are indicated in [].
| Company B | Company C | |
|---|---|---|
| Impurities [] * | ||
| Substance‐related impurities % | [7] | [7] |
| Impurity A (all‐rac‐trans‐2,3,4,6,7‐pentamethyl‐2‐(4,8,12‐trimethyltridecyl)‐2,3‐dihydrobenzofuran‐5‐ol) | 0.1–0.2 | < 0.1 |
| Impurity B (all‐rac‐cis‐2,3,4,6,7‐pentamethyl‐2‐(4,8,12‐trimethyltridecyl)‐2,3‐dihydrobenzofuran‐5‐ol | 0.4 | 0.1–0.16 |
| Impurity C (4‐methoxy‐2,3,6‐trimethyl‐5‐[(all‐RS,E)‐3,7,11,15‐tetramethylhexadec‐2‐enyl]phenol + Impurity D ((all‐RS, all‐E)‐2,6,10,14,19,23,27,31‐octamethyldotriaconta‐12,14,18‐triene) | 0.3–0.4 | < 0.10 |
| Any other impurity 1 | 0.05–0.25 | – |
| Any other impurity 2 | 0.05–0.21 | – |
| Any other impurity 3 | 0.05–0.09 | – |
| Any other impurity 4 | 0.06–0.09 | – |
| Any other impurity 5 | 0.07 [1] | – |
| Any other impurity 6 | 0.06 [1] | – |
| Any other impurities | – | 0.09–0.23 |
| Total impurities | 1.3–1.7 | 0.32–0.53 |
| Elemental impurities (mg/kg) | [4] | [3] |
| Arsenic | < 1 | < 1 |
| Cadmium | < 0.5 | – |
| Copper | < 2 | – |
| Iron | < 2 | – |
| Lead | < 2 | < 0.1 |
| Mercury | < 0.1 | – |
| Microbial contamination | [3] | |
| Salmonella spp. (per 25g) | – | n.d. |
| Staphylococcus aureus (per 25g) | – | n.d. |
| Escherichia coli (CFU/g) | – | < 10 |
| Coliforms (MNP/g) | – | < 3 |
| Yeast and moulds (CFU/g) | – | < 10 |
| Total aerobic counts (CFU/g) | – | < 10 |
| Physical properties | [7] | [7] |
| Optical rotation (°) | 0–0.01 | |
| Refractive index (589 nm, 20°C) | 1.506 | 1.505–1.506 |
Note: <: means below the limit of quantification. –: not analysed. n.d.: not detected.
Abbreviations: CFU, colony forming unit; MNP, most probable number.
Number of batches analysed per group of parameters, unless otherwise indicated.
EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed) , Villa, R. E. , Azimonti, G. , Bonos, E. , Christensen, H. , Durjava, M. , Dusemund, B. , Gehring, R. , Glandorf, B. , Kouba, M. , López‐Alonso, M. , Marcon, F. , Nebbia, C. , Pechová, A. , Prieto‐Maradona, M. , Theodoridou, K. , Galobart, J. , Manini, P. , Valeri, P. , Vettori, M. V. , & Pizzo, F. (2026). Assessment of the feed additives tocopherol extracts from vegetable oils (1b306(i)), tocopherol‐rich extracts from vegetable oils (delta rich) (1b306(ii)) and alpha‐tocopherol (1b307) for all animal species for the renewal of their authorisation (ADM International Sàrl, DSM Nutritional Products Ltd., Europe‐Asia Import Export GmbH., Vitiva d.o.o., Kaesler Nutrition GmbH, Kemin Nutrisurance Europe SRL, LUCTA S.A., Vitae Caps S.A.U/Kensing). EFSA Journal, 24(2), e9917. 10.2903/j.efsa.2026.9917
Adopted: 27 January 2026
Correspondence: Ask a Question
The declarations of interest of all scientific experts active in EFSA's work are available at https://open.efsa.europa.eu/experts.
Notes
Regulation (EC) No 1831/2003 of the European Parliament and of the council of 22 September 2003 on the additives for use in animal nutrition. OJ L 268, 18.10.2003, p. 29.
Company A: ADM International Sàrl, A One business Center, La Pièce 3, 1180, Rolle, Switzerland, represented in the EU by ADM speciality Ingredients (Europe) B.V.; Company B: DSM Nutritional Products Ltd., Wurmisweg 576, 4303, Kaiseraugst, Switzerland, represented in the EU by DSM Nutritional Products Sp. z o.o., DSM Nutritional Products Sp. z o.o., Tarczyńska 113, 96–320, Mszczonów, Poland; Company C: Europe‐Asia Import Export GmbH, Neuer Wall 40, 20,354, Hamburg, Germany; Company D: Vitiva d.o.o., Nova vas pri Markovcih 98, 2281, Markovci, Slovenia; Company E: Kaesler Nutrition GmbH, Zeppelinstrasse 3, 27,472, Cuxhaven, Germany; Company F: Kemin Nutrisurance Europe SRL Società Unipersonale, via Della Tecnica, 11, 37,040, Veronella (VR), Italy; Company G: Lucta S.A., Calle Serrano 110, 1 (despacho 2), 28,006, Madrid, Spain and Company H: Vitae Caps S.A.U (Kensing), C/Gutenberg 356. Pol Ind Torrehierro, 45,600, Talavera de la Reina, Toledo, Spain.
Commission Implementing Regulation (EU) 2015/1152 of 14 July 2015 concerning the authorisation of tocopherol extracts from vegetable oils, tocopherol‐rich extracts from vegetable oils (delta rich) and alpha‐tocopherol as feed additives for all animal species (Text with EEA relevance). 15.7.2015. OJ L 187/5.
Dossier reference: FEED‐2024‐28017.
Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. OJ L 31, 1.2.2002, pp. 1–48.
Decision available at: https://www.efsa.europa.eu/en/corporate‐pubs/transparency‐regulation‐practical‐arrangements.
Evaluation report available on the EU Science Hub https://joint‐research‐centre.ec.europa.eu/eurl‐fa‐eurl‐feed‐additives/eurl‐fa‐authorisation/eurl‐fa‐evaluation‐reports_en.
Commission Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives. OJ L 133, 22.5.2008, p. 1.
Commission Implementing Regulation (EU) 2015/1152 of 14 July 2015 concerning the authorisation of tocopherol extracts from vegetable oils, tocopherol‐rich extracts from vegetable oils (delta rich) and alpha‐tocopherol as feed additives for all animal species. OJ L 187, 15.07.2015, p. 5.
The CAS No. 490‐23‐3 used in the authorising regulation refers to beta‐tocotrienol and should be replaced by the CAS No 16698‐35‐4 and EC number 240‐747‐1, associated to natural (R)‐beta tocopherol. The other CAS No 146‐03‐8 and EC number 205‐708‐5 are associated to beta‐tocopherol (racemic/synthetic).
Annex_II‐1_Batch_CoA_A_conf.pdf, Annex_II‐29_Batch_CoA_D_conf.pdf, Annex_II_2024‐11‐29‐RFIreply_Identification_Process_D Annex_II‐4_Batch_CoA_E_conf.pdf, Annex_II 5_Batch_CoA_F_conf.pdf, Annex_II‐6_Batch_CoA_G_conf.pdf, Annex_II 7_Batch_CoA_H.pdf.
Annex_II‐8_Impurities_A_conf.pdf, Annex_II_2024‐11‐29‐RFI‐reply_Identification_Process_A_conf.pdf, Annex_II‐11_Impurities_D_conf.pdf, Annex_II_2024‐11‐29‐RFI‐reply_Identification_Process_D_conf.pdf, Annex_II‐12_Impurities_E_conf.pdf, Annex_II_2024‐11‐29‐RFI‐reply_Identification_Process_E_conf.pdf, Annex_II‐13_Impurities_F_conf.pdf, Annex_II_2024‐11‐29‐RFI‐reply_Identification_Process_F_conf.pdf, Annex_II‐14_Impurities_G_conf.pdf, Annex_II_2024‐11‐29‐RFI‐reply_Identification_Process_G_conf.pdf, Annex_II‐15_Impurities_H_conf.pdf, Annex_II_2024‐11‐29‐RFI reply_Identification_Process_H_conf.pdf.
Annex_II‐8_Impurities_A_conf.pdf, Annex_II_2024‐11‐29‐RFI‐reply_Identification_Process_A_conf.pdf, Annex_II‐11_Impurities_D_conf.pdf, Annex_II_2024‐11‐29‐RFI‐reply_Identification_Process_D_conf.pdf, Annex_II‐12_Impurities_E_conf.pdf, Annex_II_2024‐11‐29‐RFI‐reply_Identification_Process_E_conf.pdf, Annex_II‐13_Impurities_F_conf.pdf, Annex_II_2024‐11‐29‐RFI‐reply_Identification_Process_F_conf.pdf, Annex_II‐14_Impurities_G_conf.pdf, Annex_II_2024‐11‐29‐RFI‐reply_Identification_Process_G_conf.pdf, Annex_II‐15_Impurities_H_conf.pdf, Annex_II_2024‐11‐29‐RFI reply_Identification_Process_H_conf.pdf.
Commission Recommendation of 17 August 2006 on the presence of deoxynivalenol, zearalenone, ochratoxin A, T‐2 and HT‐2 and fumonisins in products intended for animal feeding (2006/576/EC). OJ L 229 23.8.2006, p. 7.
The CAS No. 490‐23‐3 used in the authorising regulation refers to beta‐tocotrienol and should be replaced by the CAS No 16698‐35‐4 and EC number 240‐747‐1, associated to natural (R)‐beta tocopherol. The other CAS No 146‐03‐8 and EC number 205‐708‐5 are associated to beta‐tocopherol (racemic/synthetic).
Annex_II‐4_Batch_CoA_E_conf, Annex_II‐5_Batch_CoA_F_conf; Annex_II_2024‐11‐29‐RFI‐reply_Identification_Process_E_conf.pdf.
Annex_II_2024‐11‐29‐RFI‐reply_Identification_Process_E_conf.pdf, Annex_II‐13_Impurities_F_conf.pdf.
Annex_II_2024‐11‐29‐RFI‐reply_Identification_Process_E_conf.pdf, Annex_II‐13_Impurities_F_conf.pdf.
Annex_II‐2_Batch_CoA_B_conf, Annex_II‐3_Batch_CoA_C_conf.
Annex_II_2024‐11‐29‐RFI‐reply_Identification_Process_B_conf.pdf, Annex_II‐9_Impurities_B_conf.pdf, Annex_II‐10_Impurities_C, Annex_II_2024‐11‐29‐RFIreply_Identification_Process_C.
Annex_II_2024‐11‐29‐RFI‐reply_Identification_Process_B_conf.pdf, Annex_II‐9_Impurities_B_conf.pdf, Annex_II‐10_Impurities_C, Annex_II_2024‐11‐29‐RFIreply_Identification_Process_C.
Annex_III‐5_Monitoring of adverse events_conf.pdf.
Annex_III‐3_Extensive_literature_search_conf_revised.pdf.
The average body weight (bw) for the population category ‘Infants 7–11 months’ has been calculated considering the following body weights reported in the NDA Panel opinion (EFSA NDA Panel, 2024): ‘Infants 4–6 months’ 7.2 kg and ‘Infants 7–11 months’ 8.6 kg.
Annex_III‐9_EDQM_202200322_1.0_SDS_EN.pdf.
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