Committee Advice on the assessment of Schizochytrium sp. oil rich in DHA and EPA as a novel ingredient in meat and fish analogues

Reference Number RP1411

Assessment finalised: 12th of December 2023

Summary

An extension of use application was submitted to the Food Standards Agency (FSA) and Food Standards Scotland (FSS) in January 2022 from DSM Nutritional Products, Switzerland (“the applicant”) for the authorisation of Schizochytrium sp. oil rich in DHA and EPA as an ingredient in two new food categories: meat and fish analogues.

An application for one form of Schizochytrium sp. oil was originally submitted to the Food Standards Agency in 2001, subsequently receiving a positive opinion from the ACNFP in 2003, under the novel foods regulation 258/97 EC and was subject to authorisation by the EU. Since the original authorisation, a number of extension of use applications, both for the original form and two further related formulations including the one seeking an extension of use in this application, have since been submitted and approved.

To support the FSA and FSS in their evaluation of the application, the Advisory Committee on Novel Foods and Processes (ACNFP) were asked to review the safety dossier and supplementary information provided by the applicant. Please note the Committee did not consider any potential health benefits or claims arising from consuming the food, as the focus of the novel food assessment is to ensure the food is safe, and not putting consumers at a nutritional disadvantage.

The Committee concluded that the specified novel food is safe under the newly proposed uses, as an ingredient within meat and fish analogues. The additional uses were not considered to be nutritionally disadvantageous.

1. Introduction

To support the risk assessment for the extension of use request for Schizochytrium sp. oil rich in DHA and EPA, the ACNFP provided the advice outlined in this document to the FSA and FSS. This document outlines the conclusions of the ACNFP on the safety of Schizochytrium sp. oil rich in DHA and EPA under the proposed extension of use.

The evaluation by the ACNFP assessed the food safety risks of the novel ingredient and its production, in line with Article 7 of regulation (EU) 2017/2469, retained in UK law. The regulatory framework and the technical guidance put in place by the European Food Safety Authority (EFSA) for novel food applications is retained as the basis and structure for the assessment.

Following the review by the ACNFP at their meeting in February 2023, further information was requested concerning the specification, stability, and proposed uses of the novel ingredient. Further information was subsequently provided by the applicant in May 2023 and reviewed further in September 2023. The assessment was completed at the 162nd ACNFP meeting, following the review of the further information provided.

This document outlines the conclusions of the ACNFP assessment on the safety of the proposed extension of use of Schizochytrium sp. oil rich in DHA and EPA as an ingredient in meat and fish analogues.

2. Assessment

2.1. Identity of the novel ingredient

The novel ingredient is an oil which is rich in docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), derived from the heterotrophically grown marine microalgae, Schizochytrium sp. otherwise known as DHA-O. This DHA and EPA rich oil from Schizochytrium sp. (hereafter referred to as ‘DHA and EPA-rich oil’ or ‘DHA-O oil’) has a fatty acid profile that more closely represents that of common sources of long-chain omega-3 oils which are present naturally in the human diet. The DHA and EPA-rich oil contains a minimum level of 22.5% DHA and a minimum level of 10% EPA as outlined in the original UK opinion by the ACNFP in 2012, on the extension of use of Schizochytrium sp. Oil known as DHA - O with the composition as described above.

The source of the oil is a strain of Schizochytrium sp. algae. The taxonomic ranking of the source microalgae is defined below:

• Kingdom = Chromista (Stramenopilia)
• Phylum = Heterokonta
• Class = Thaustochytridae
• Order = Thaustochytriales
• Family = Thaustochytridiaceae
• Genus = Schizochytrium
• Species/Strain = DHA-O

No additional information on the identity of the novel food was provided, as it remains unchanged from the initial authorisation. Therefore, no review of information on identity was undertaken as the initial conclusions on safety remain the same.

2.2. Production Process

There are no changes to the production process of the novel ingredient since the original authorisation for DHA-O oil. DHA-O oil is produced via a self-contained fermentation process using an alga from the genus Schizochytrium. The algae are grown in a pure culture heterotrophic fed-batch fermentation process and recovered from the fermentation broth. The subsequent oil recovery stages may be applied to either the recovered, dried algae (following reconstitution in water) or the fermentation broth may be used directly in the oil recovery process, in which case a pasteurisation step may be employed. Antioxidants may be added to the fermentation broth to aid stability in processing.

Fresh Schizochytrium sp. broth or reconstituted dried algae (from Schizochytrium sp. fermentation) may be used in the process. The mixture is then heated and centrifuged to separate the oil from the aqueous phase. The oil phase is dried and stored for oil purification.

The crude oil is further refined into the finished product using process operations commonly employed in the vegetable oil industry. Approved antioxidants are added to the oil to provide stability. At this stage the DHA and EPA percentage may be standardised by the addition of food grade vegetable oil, for example high oleic sunflower oil.

No additional information was provided on production process in support of the extension of use application, therefore this was not reviewed. The conclusions remain that there are not expected to be any safety concerns related to the production process for this novel food.

2.3. Specifications and Composition

There are no changes to the specification or composition of the novel ingredient since the original authorisation for DHA-O oil. Below are the specifications set out for Schizochytrium sp. oil rich in DHA and EPA in legislation, along with quality control analyses of three independent batches of product to provide evidence of compliance to the specifications was provided in the original assessment. Analysis of three representative batches of the novel food was the standard required at the time of the assessment.

Table 1 shows the specification for DHA-O oil and the analytical results for three independent batches of the novel ingredient as provided in the original application in 2011.

Table 1: Compositional specification and analytical results for DHA-O oil

Test Parameter	Specification	Batch 1	Batch 2	Batch 3
Acid Value	≤0.5 mg KOH/g	0.4	0.2	0.5
Peroxide Value	≤5.0 meq/kg of oil	2.2	1.7	3.6
Moisture and Volatiles	≤0.05%	<0.01	0.01	<0.01
Unsaponifiable Content	≤4.5%	1.2	1.1	1.1
Trans-fatty Acids	≤1%	<0.05	<0.05	<0.05
DHA Content	≥22.5%	35.1	33.3	32.7
EPA Content	≥10%	15.9	14.9	17.7

Additional compositional analyses are provided, which cover the requirements of regulation 2015/2283, as retained in UK law. Table 2 displays residual solvents, protein, and heavy metal composition of three independent batches of the novel ingredient. Table 3 displays the mean fatty acid profile of three batches of the novel ingredient. Table 4 displays the mean unsaponifiable composition of three batches of the novel ingredient.

Table 2: Residual solvents, protein, and heavy metal composition of three independent batches of DHA-O oil

Test Parameter	Batch 1	Batch 2	Batch 3
Residual Solvent – IPA (mg/kg)	<1.0	<1.0	<1.0
Protein by Kjeldahl (%N x 6.25)	<0.02	<0.02	<0.02
Arsenic (mg/kg)	<0.2	<0.2	<0.2
Copper (mg/kg)	<0.02	<0.02	<0.02
Iron (mg/kg)	0.02	0.02	0.02
Mercury (mg/kg)	<0.04	<0.04	<0.04
Lead (mg/kg)	<0.1	<0.1	<0.1

Table 3: Mean fatty acid composition of three independent batches of DHA-O oil

Fatty Acid	Content mg free fatty acids (% w/w oil)
14:0 Myristic	1.59
14:1 Myristoleic	0.00
15:0 Pentadecanoic	0.40
16:0 Palmitic	18.56
17:0 Heptadecanoic	0.08
18:0 Stearic	1.20
18:1 (n-9)* Oleic	3.90
18:1 (n-7)* cis-vaccenic	0.03
18:2 Linoleic	0.50
18:4 Ocadecatetraenoic	0.07
20:0 Eicosanoic	0.37
20:1 Eicosenoic acid	0.01
20:3 (n-6) Eicosatrienoic	0.04
20:4 (n-6) Arachidonic	1.37
20:3 (n-3) Eicosatrienoic	0.12
20:4 (n-3) Eicosatetraenoic	0.55
20:5 (n-3) Eicosapentaenoic	16.18
22:0 Docosanoic	0.17
22:1 (n-11) Cetoleic	0.07
22:4 (n-6) Docosatetraenoic	0.23
22:5 (n-6) Docosapentaenoic	1.27
22:5 (n-3) Docosapentaenoic	3.61
24:0 Tetracosanoic	0.11
22:6 (n-3) Docosahexaneoic	33.72
Minor Components (individual fatty acids <0.005mg FFA/g)	0.12
Total Fatty Acids	84.27

Table 4: Mean unsaponifiable content of three independent batches of DHA-O oil

Sterol	Content (% w/w oil)
Cholesterol	0.182
Cholestanol	0.000
Brassicasterol	0.008
24-Methylene cholesterol	0.006
Campesterol	0.005
Campestanol	0.000
Stigmasterol	0.505
∆-7-Campesterol	0.002
∆-5,23-stigmastadienol	0.003
Clerosterol	0.015
ꞵ-sitosterol	0.033
Sitostanol	0.001
∆-5-avenasterol	0.008
∆-5,24-stigmastadienol	0.003
∆-7-stigmastenol	0.003
∆-7-avenasterol	0.001
Total Sterols	0.775

Further to the routine compositional analyses performed, the product conforms with the levels laid down in regulation 2006/1881 which sets out the maximum levels for certain contaminants in foodstuffs. This confirms the absence of significant levels of: dioxins, polycyclic aromatic hydrocarbons, pesticides, acrylamide, algal toxins, and microorganisms.

Further clarification of information was sought by the Committee in relation to how the extension of use fits within the currently authorised specifications for DHA oils. It was clarified that the application was seeking to amend  the entry in the list of authorised novel foods for ‘Schizochytrium sp. oil rich in DHA and EPA’ and its corresponding specification also known as DHA -O. There are no changes to the existing specification as part of the new evaluation.

The data provided assures no changes from the previously authorised specification for the novel food and therefore no additional safety concerns were identified from the new data provided. As such no changes to the specification were identified by the Committee.

2.4. Stability

The stability of the novel ingredient remains unchanged since the original extension of use authorisation for DHA-O oil. However, as this extension of use pertains to a change in use of the novel ingredient (addition of the novel ingredient to two new food categories; meat and fish analogues), a further consideration of stability under the newly proposed uses was made by the ACNFP. Further information and data on its stability within the new food matrices have since been provided by the applicant, which show that the novel food remains stable under the newly proposed uses: meat analogues and fish analogues. No further specific safety concerns were raised by the Committee.

2.5. History of Use

Schizochytrium sp. oil rich in DHA and EPA (DHA-O oil) is currently authorised as a novel food within the UK and EU. The original application for this form of DHA oil was received in April 2011 and subsequently authorised in 2012 under the Novel Food Regulation (EC) 258/97.  The text relates to omega-3 fatty acids which have a demonstrated history of use and natural prevalence within the human diet.

2.6. Proposed Use, Use Levels, and Anticipated Intake

The extension of use for the novel ingredient will increase the number of permitted food categories by two, to include both meat and fish analogues. These additions enable food manufacturers to deliver doses of DHA and EPA that could be found naturally in fish and meat products, in the newly proposed food categories. 
Table 5 shows the list of currently authorised food categories and their specified maximum use levels, along with the two newly proposed food categories and their proposed maximum use levels

Table 5: Authorised and newly proposed food categories for the use of Schizochytrium sp. oil rich in DHA and EPA and their maximum use levels

Specified Food Category	Maximum combined use level of DHA and EPA
Food Supplements as defined in Directive 2002/46/EC for adult population excluding pregnant and lactating women	3,000 mg/day
Food Supplements as defined in Directive 2002/46/EC for pregnant and lactating women	450 mg/day
Foods for special medical purposes as defined in Regulation (EU) No 609/2013	In accordance with the particular nutritional requirements of the persons for whom the products are intended
Total diet replacement for weight control as defined in Regulation (EU) No 609/2013 and meal replacements for weight control	250 mg/meal
Milk-based drinks and similar products intended for young children	200 mg/100 g
Processed cereal based food and baby food for infants and young children as defined in Regulation (EU) No 609/2013	200 mg/100 g
Foods intended to meet the expenditure of intense muscular effort, especially for sportsmen	200 mg/100 g
Foods bearing statements on the absence or reduced presence of gluten in accordance with the requirements of Commission Implementing Regulation (EU) No 828/2014	200 mg/100 g
Bakery Products (Breads, Rolls and Sweet Biscuits)	200 mg/100 g
Breakfast Cereals	500 mg/100 g
Cooking Fats	360 mg/100 g
Dairy Analogues except drinks	600 mg/100 g for cheese; 200 mg/ 100 g for soy and imitation milk products (excluding drinks)
Dairy Products except milk-based drinks	600 mg/100 g for cheese; 200 mg/ 100 g for milk products (including milk, fromage frais and yoghurt products; excluding drinks)
Non-alcoholic Beverages (including dairy analogue and milk-based drinks)	80 mg/100 g
Cereal/Nutrition Bars	500 mg/100 g
Spreadable Fats and Dressings	600 mg/100 g
Newly Proposed Food Categories
Fish analogues	300 mg/100g
Meat analogues	300 mg/100g

Estimates for the intakes of DHA and EPA combined from Schizochytrium sp. oil in EU Member States were conducted using the authorised and proposed food uses and use levels in combination with food consumption data from the European Food Safety Authority (EFSA) Comprehensive Food Consumption Database (hereafter referred to as the EFSA Comprehensive Database). The estimated intakes of DHA and EPA were calculated on a per person and per kilogram body weight basis and are reported for each age category for the countries examined. The calculations were based on databases including UK data and therefore were considered to appropriately estimate consumer exposure in the UK.

Table 6 reports the highest mean and highest high levels of DHA+EPA for each of the population groups covered. The table also compares the overall intakes of the existing authorisations with the overall intakes including the proposed extension, the last column showing the increase of intake in mg/day for both the mean and high values.

Table 6: Comparison of the estimated daily intake of DHA and EPA from Schizochytrium sp. Oil in different population groups from authorised and proposed food uses in the EU (EFSA Comprehensive Database, 2020)

Population Group (Age)	Number of Surveys	Mean Maximum Intake of DHA and EPA (mg/day) from Authorised Food Uses	High Level Maximum Intake of DHA and EPA (mg/day) from Authorised Food Uses	Mean Maximum Intake of DHA and EPA (mg/day) from Authorised and Proposed Food Uses	High Level Maximum Intake of DHA and EPA (mg/day) from Authorised and Proposed Food Uses	Change in Mean Maximum Intake (mg/day)	Change in High Level Maximum Intake (mg/day)
Infants (<11 months)	13 (11)	885	1523	886	1523	+1	0
Toddlers (12 to 15 months)	20 (17)	1135	2475	1142	2485	+7	+10
Other Children (3 to 9 years)	30 (30)	1495	2655	1515	2656	+20	+1
Adolescents (10 to 17 years)	30 (29)	1564	2165	1577	2175	+13	+10
Adults (18 to 64 years)	34 (34)	1698	3363	1707	3372	+9	-9
Pregnant and lactating women	7 (7)	1155	1960	1176	1981	+21	+21
Elderly (65 to 74 years)	24 (24)	1758	3373	1767	3382	+9	+9
Very Elderly (≥75 years)	17 (12)	1281	2208	1295	2220	+14	+12

Overall, the impact of including meat and fish analogues in the intake assessment of ‘DHA and EPA from Schizochytrium sp. oil’ is minimal/negligible for all target population groups (taking into account the general uncertainties related to the methodology itself). This reflects that consumers are unlikely to be eating meat and fish analogues as well as foods high in DHA and EPA in a single sitting. It is expected that therefore the new categories will not provide DHA and EPA at levels that would be considered a safety risk, nor allow for excessive consumption of DHA and EPA.

Queries were raised by the Committee in relation to the range of products subject to the new food categories. This provided a basis to establish if there could be nutritional disadvantage from consuming these products as a replacement for meat and fish. Further information was provided by the applicant which details examples of such products. It was explained that the proposed use is as an alternative to other sources in the diet and the nature of the products would suggest these are not consumed at the same eating occasion as an additional source of DHA and EPA. No safety concerns were raised to the addition of the novel food to the new food categories and the Committee does not consider there to be any nutritional disadvantage to consuming the novel food within the new food categories.

2.7. Absorption, Distribution, Metabolism, and Excretion (ADME)

There are no changes to the adsorption, distribution, metabolism, or excretion of the novel ingredient since the original authorisation for DHA-O oil. The Committee considers that previous conclusions remain appropriate for the extension of use and no further review of ADME was required.

2.8. Nutritional Information

No additional data was presented on the nutritional profile of the novel food and as such no review of nutritional information was provided. It was noted that there are specific groups of the population that do not consume fish and fish-derived products such as fish oil, or meat or meat derived products due to allergenicity or diet choices (such as in veganism or vegetarianism). The authorisation of ‘DHA and EPA-rich oil’ in these additional food categories was considered to provide alternative sources for these components of the diet for those consumers.

2.9. Toxicological Information

There are no changes to the toxicological profile of the novel ingredient since the original authorisation for DHA-O oil. A NOAEL was identified at 200g per person, per day of DHA-O or 100g per person, per day of DHA and EPA.

The original 2011 ACNFP opinion noted:

“In addition to the toxicological studies carried out on DHA and EPA-rich oil, the applicant notes that its traditional counterpart, fish oil, is widely used both in food supplements and in fortified foods in the EU without restriction.”

The toxicity of DHA and EPA-rich oils produced from different strains of Schizochytrium sp. has been extensively reviewed and investigated over the years. In all previous reviews and investigations, the competent authorities have concluded that there were no concerns with regards to genotoxicity and sub-chronic toxicity of the tested materials.

There has been no additional data produced since the previous application and the Committee considers the conclusions to remain relevant for the proposed extension of use.

2.10. Allergenicity

There have been no changes to the allergenicity of the novel food since its initial authorisation. Therefore, the Committee considers the initial conclusions on allergenicity to remain relevant for the proposed additional food categories.

3. Discussion

The application is for an extension of use of Schizochytrium sp. oil rich in DHA and EPA within two new food categories: meat and fish analogues. The specification remains unchanged from the original authorisation, where no safety concerns were raised and therefore is not expected to be of concern under the newly proposed uses.

The addition of two new food categories is not expected to have any impact on exposure to DHA and EPA based on consumption of the sources being mutually exclusive. Where consumption of one source of DHA and EPA is usually replaced with another rather than being consumed simultaneously. Any increase in exposure to the novel food is expected to be within populations who do not currently consume DHA and EPA through natural sources due to diet choices.

Consumption of the novel food is also not expected to be nutritionally disadvantageous, as the nutritional profile also remains unchanged since the initial authorisation. Consumption of the novel food under the newly proposed uses also delivers DHA and EPA at levels similar to those found naturally within a regular human diet.

4. Conclusions

The ACNFP has undertaken a safety assessment of the extension of use of Schizochytrium sp. oil rich in DHA and EPA. The extension of use for the novel ingredient will increase the number of permitted food categories by two, to include both meat and fish analogues. The overall purpose for these additions is to enable food manufacturers to deliver doses of DHA and EPA that could be found in fish and meat products and to meet the labelling requirements for “source” and “high” in Omega-3 fatty acids as specified within Commission Regulation (EU) No 116/2010 of 9 February 2010 amending Regulation (EC) No 1924/2006 of the European Parliament and of the Council with regard to the list of nutrition claims. 

No changes were made, nor additional data supplied, on identity and characterisation, production process, composition or specification of the oil itself, nutritional profile, ADME, toxicological or allergenicity data since the original authorisation for this form of DHA oil in 2012. As such no review was made of these sections and the original conclusions were considered to apply to the extension of use.

The ACNFP concluded that the specified novel food is safe under the newly proposed uses, as an ingredient within meat and fish analogues. The additional uses were not considered to be nutritionally disadvantageous.

The members of the ACNFP during the course of the assessment were; Dr Camilla Alexander White, Dr Anton Alldrick, Alison Austin, Dr Mark Berry, Professor Dimitris Charalampopoulos, Professor Susan Fairweather-Tait, Professor Paul Frazer, Dr Hamid Ghoddusi, Professor Andy Greenfield, Professor Wendy Harwood, Professor Huw Jones, Dr Ray Kemp, Dr Elizabeth Lund,  Professor Harry J McArdle, Mrs Rebecca McKenzie,  Professor Clare Mills, Dr Lesley Stanley, Professor Hans Verhagen, Dr Maureen Wakefield, and Professor Bruce Whitelaw.

ACNFP (2011) INITIAL OPINION: A DHA AND EPA RICH OIL FROM THE MICROALGAE SCHIZOCHYTRIUM; ACNFP website archive [ARCHIVED CONTENT] DHA and EPA-rich Algal Oil. EC No. 128 | Food Standards Agency (nationalarchives.gov.uk)

EFSA, 2021 EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA Panel). Guidance on the preparation and submission of an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283 (Revision 1). Published 26 March 2021. https://doi.org/10.2903/j.efsa.2011.2170 (Opens in a new window)

EU, 2017. Commission Implementing Regulation (EU) 2017/2469 of 20 December 2017 laying down administrative and scientific requirements for applications referred to in Article 10 of Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods. COMMISSION IMPLEMENTING REGULATION (EU) 2017/2469 

FSA, 2012. Authorisation letter for DHA AND EPA RICH OIL FROM THE MICROALGAE SCHIZOCHYTRIUM. ACNFP website archive [ARCHIVED CONTENT] (nationalarchives.gov.uk)

Abbreviations

ACNFP          Advisory Committee on Novel Foods and Processes

ADME           Adsorption, Distribution, Metabolism, and Excretion

DHA              Docosahexaenoic Acid

DHA-O          Novel Production Strain of Schizochytrium sp. algae

EFSA            European Food Safety Authority

EPA               Eicosapentaenoic Acid

EU                 European Union

FFA               Free Fatty Acids

FSA               Food Standards Agency

FSS               Food Standards Scotland

g                    Grams

GB                 Great Britain

kg                  Kilograms

Ltd                 Limited Company

mg                 Milligrams