Safety of Allanblackia seed oil for extended uses in vegetable oils and milk and in yellow fat and cream‐based spreads up to 30% (w/w)

Abstract

In 2007, the EFSA NDA Panel concluded that Allanblackia seed oil obtained from the seeds of Allanblackia trees is safe for human consumption under the proposed conditions of use. Due to its high contents of stearic‐oleic‐stearic and stearic‐oleic‐oleic triglycerides, which made the oil suitable as a ‘hardstock’ component, the applicant applied for its use as a novel food (NF) ingredient in yellow fat and cream‐based spreads at a level of 20% (w/w). In this application, the applicant seeks (1) to increase the authorised maximum use level (i.e. 20% w/w) in yellow fat spreads and cream‐based spreads to 30% (w/w) and (2) the use of this NF in mixes of vegetable oils and milk up to a maximum use level of 30% (w/w). (3) The applicant proposes also some changes in the specifications of the NF, although he noted that the oil is collected, extracted and refined using the same processes that are currently used for other edible vegetable oils and which have been evaluated in the original application assed by EFSA in 2007. According to the information provided by the applicant, the production process and the composition of the NF do not change. The Panel notes that the revised specification limits on trans‐fatty acid (TFA), unsaponifiable matter, peroxide value are similar to those for other edible oils and fats. The applicant also indicated that he had performed an updated comprehensive literature search using several different databases, but no preclinical studies or human studies on Allanblackia seed oil were identified which have not been provided for the previous EFSA assessment in 2007. The Panel notes that the proposed extended uses would increase the potential intake of the NF, which is considered not to be nutritionally disadvantageous. The Panel concludes that Allanblackia seed oil is safe at the extended uses and use level.

Summary

Commission Decision 2008/559/EC authorised, in accordance with Regulation (EC) No 258/97 and following the European Food Safety Authority's Opinion,1 the placing on the market of Allanblackia seed oil as a novel food (NF) ingredient to be used in yellow fat spreads and cream‐based spreads.

On 22 September 2014, the company Unilever NV/Unilever PLC submitted a request to the competent authority of the Netherlands in accordance with Article 4 of Regulation (EC) No 258/97 for an extension of use and use levels of Allanblackia seed oil. The application requested to extend the use of Allanblackia seed oil to additional food categories, namely, mixtures of vegetable oil and milk. The applicant also requested to increase maximum use levels of Allanblackia seed oil for food categories already authorised by Commission Decision 2008/559/EC. The competent authority of the Netherlands forwarded to the Commission its initial assessment report. In that report, it came to the conclusion that the extension of uses and proposed maximum use levels of Allanblackia seed oil meet the criteria for NF set out in Article (3)1 of Regulation (EC) No 258/97. In accordance with Article 10(3) of Regulation (EU) 2015/2283, the European Commission asks the European Food Safety Authority to provide a scientific opinion by carrying out the additional assessment for Allanblackia seed oil as a NF.

In 2007, the EFSA NDA Panel concluded that Allanblackia seed oil obtained from the seeds of the Allanblackia trees (A. floribunda and A. stuhlmannii), is safe for human consumption under the proposed conditions of use. Due to its high contents of stearic‐oleic‐stearic and stearic‐oleic‐oleic triglycerides, which made the oil suitable as a ‘hardstock’ component, the applicant applied for its use as a NF ingredient in yellow fat and cream‐based spreads at a level of 20% (w/w). In this application, the applicant seeks (1) to increase the authorised maximum use level (i.e. 20% w/w) in yellow fat spreads and cream based spreads to 30% (w/w) and (2) the use of this NF in mixes of vegetable oils and milk up to a maximum use level of 30% (w/w). (3) The applicant proposes also some changes in the specifications of the NF, although he noted that the oil is collected, extracted and refined using the same processes that are currently used for other edible vegetable oils and which have been evaluated in the original application assed by EFSA in 2007. The applicant also indicated that he had performed an updated comprehensive literature to identify toxicological and human studies on Allanblackia seed oil which have become available since the previous EFSA assessment in 2007.

According to the information provided by the applicant, the production process and the composition of the NF do not change. The Panel notes that the revised specification limits on trans‐fatty acid (TFA), unsaponifiable matter, peroxide value are similar to those for other edible oils and fats.

The applicant also indicated that he had performed an updated comprehensive literature search using several different databases, but no preclinical studies or human studies on Allanblackia seed oil were identified which have not been provided for the previous EFSA assessment in 2007.

The Panel notes that the proposed extended uses would increase the potential intake of the NF, which is considered not to be nutritionally disadvantageous.

The Panel concludes that Allanblackia seed oil is safe at the extended uses and use level.

1. Introduction

1.1. Background and Terms of Reference as provided by the European Commission

Commission Decision 2008/559/EC2 authorised, in accordance with Regulation (EC) No 258/973 and following the European Food Safety Authority's Opinion4, the placing on the market of Allanblackia seed oil as a novel food (NF) ingredient to be used in yellow fat spreads and cream based spreads.

On 22 September 2014, the company Unilever NV/Unilever PLC submitted a request to the competent authority of the Netherlands in accordance with Article 4 of Regulation (EC) No 258/97 for an extension of use and use levels of Allanblackia seed oil. The application requested to extend the use of Allanblackia seed oil to additional food categories, namely, mixtures of vegetable oil and milk. The applicant also requested to increase maximum use levels of Allanblackia seed oil for food categories already authorised by Commission Decision 2008/559/EC.

On 18 December 2017, the competent authority of the Netherlands forwarded to the Commission its initial assessment report. In that report it came to the conclusion that the extension of uses and proposed maximum use levels of Allanblackia seed oil meet the criteria for NF set out in Article (3)1 of Regulation (EC) No 258/97.

Pursuant to Article 35(1) of Regulation (EU) 2015/2283, any request for placing a NF on the market within the Union submitted to a Member State in accordance with Article 4 of Regulation (EC) No 258/97 of the European Parliament and of the Council3 and for which the final decision has not been taken before 1 January 2018 shall be treated as an application submitted under Regulation (EU) 2015/2283.

In accordance with Article 10(3) of Regulation (EU) 2015/22835, the European Commission asks the European Food Safety Authority to provide a scientific opinion by carrying out the additional assessment for Allanblackia seed oil as a NF.

2. Data and methodologies

2.1. Data

Administrative and scientific requirements for NF applications referred to in Article 10 of Regulation (EU) 2015/2283 are listed in the Commission Implementing Regulation (EU) 2017/24696.

A common and structured format on the presentation of NF applications is described in the EFSA guidance on the preparation and presentation of a NF application7. As indicated in this guidance, it is the duty of the applicant to provide all of the available (proprietary, confidential and published) scientific data, including both data in favour and not in favour to supporting the safety of the proposed NF.

This NF application does not include a request for protection of proprietary data in accordance with Article 26 of Regulation (EU) 2015/2283.

2.2. Methodologies

The assessment follows the methodology set out in the EFSA guidance on NF applications and the principles described in the relevant existing guidance documents from the EFSA Scientific Committee. The legal provisions for the assessment are laid down in Article 11 of Regulation (EU) 2015/2283 and in Article 7 of the Commission Implementing Regulation (EU) 2017/2469.

This assessment concerns only risk that might be associated with consumption of the NF under the proposed conditions of use, and is not an assessment of the efficacy of Allanblackia seed oil with regard to any claimed benefit.

3. Assessment

In 2007, the EFSA NDA Panel concluded that Allanblackia seed oil obtained from the seeds of the Allanblackia trees (A. floribunda and A. stuhlmannii) is safe for human consumption under the proposed conditions of use (EFSA NDA Panel, 2007). Due to its high contents of stearic‐oleic‐stearic and stearic‐oleic‐oleic triglycerides, which made the oil suitable as a ‘hardstock’ component, the applicant applied for its use as a NF ingredient in yellow fat and cream‐based spreads at a level of 20% (w/w). In that opinion, intake estimates for Allanblackia seed oil were performed on the basis of margarine and yellow fat spread consumption in Germany, Sweden, the UK and the Netherlands, taking into account the maximum intended use level of 20%. Based on a 95th percentile margarine intake of 39 g/person per day across all age groups in Germany, an intake of approximately 8 g of Allanblackia seed oil/person per day was estimated. For Sweden, the UK and the Netherlands, the applicant estimated Allanblackia seed oil intakes (95th percentile) to range from 2.8 g/person per day for British toddlers to 16 g/person per day for Swedish women. The 95th percentile intake estimate for adults in the UK and the Netherlands was 11 and 14 g/person per day, respectively. In a 90‐day feeding study with rats, the administration of 20% Allanblackia seed oil did not induce any toxicologically relevant effects which were attributable to administration of Allanblackia seed oil and which are not also seen in animal studies with other high fat diets.

In this application, the applicant seeks (1) to increase the authorised maximum use level (i.e. 20% w/w) in yellow fat spreads and cream‐based spreads to 30% (w/w) and (2) the use of this NF in mixes of vegetable oils and milk up to a maximum use level of 30% (w/w). (3) The applicant proposes also some changes in the specifications of the NF, although he noted that the oil is collected, extracted and refined using the same processes that are currently used for other edible vegetable oils and which have been evaluated in the original application assed by EFSA in 2007.

The applicant also indicated that he had performed an updated comprehensive literature to identify toxicological and human studies on Allanblackia seed oil which have become available since the previous EFSA assessment in 2007.

3.1. Specifications

The applicant proposes some changes of the specifications authorised by the Commissions Decisions 2008/559/EC as outlined in Table 1. The proposals concern (1) the simplification of the notion of small amounts of the saturated fatty acids (FA), lauric‐, myristic‐ and palmitic acid to one combined parameter (i.e. C12:0–C16:0), (2) the omission of the notion of small amounts (each below 1%) of palmitoleic and arachidic acid and of the iodine value, and (3) increases of the maximum limits for the peroxide value (from ≤ 0.8 to ≤ 1.0 meq/kg), for trans‐fatty acids (TFAs) (from ≤ 0.5% to ≤ 1%) and for the unsaponifiable matter (from ≤ 0.1% to ≤ 1%).

Table 1.

Specification for refined Allanblackia seed oil

Commission Decision 2008/559/EC of 27 June 2008		Proposed changes
Lauric acid (C12:0)	< 1%	< 4% (C12:0–C16:0)
Myristic acid (C14:0)	< 1%
Palmitic acid (C16:0)	< 2%
Palmitoleic acid (C16:1)	< 1%	Omitted
Stearic acid (C18:0)a	45–58%
Oleic acid (C18:1)a	40–51%
Linoleic acid (C18:2)	< 1%	PUFAsb < 2%
γ‐Linolenic acid (C18:3)	< 1%
Arachidic acid (C20:0)		Omitted
Free fatty acidsa	Max. 0.1%
Trans‐fatty acids	Max. 0.5%	Max. 1%
Peroxide value	Max. 0.8 meq/kg	Max. 1 meq/kg
Iodine value	< 46 g/100 g	Omitted
Unsaponifiable matter	Max. 0.1%	Max. 1%
Saponification valuea	185–198 mg KOH/g

^aUnchanged.

^bPUFAs: poly unsaturated fatty acids.

In response to a question raised by the competent authority of the Netherlands regarding possible changes of the composition and/or the production process of the NF, the applicant responded that Allanblackia seed oil that is subject of this application is identical to the Allanblackia seed oil that was presented in the original application dossier assessed by EFSA in 2007 and authorised under decision 2008/559/EC.

The applicant noted that the proposed increase the limit of the unsaponifiable matter does not reflect actual changes of the composition or of the production process, but results from a review of batches tested between 2000 and 2015. The results of these analyses are provided in Table 2 which show that the unsaponifiable matter was below 1% in the tested batches.

Table 2.

Testing of batches from the years 2000–2015

Batch code	Year	Status Allanblackia seed oil	Total unsaponifiables [% w/w]	Total sterol content [% w/w]	Guttiferone [mg/kg]
BEZ200005‐299	2000	Crude	0.50	n.a.	n.a.
HSP200106‐130	2001	Crude	n.a.	0.13	< LOD*
HSP200105‐108	2001	Crude	n.a.	0.18	n.a.
FPK200407‐096	2004	Crude	0.53	0.12	n.a.
RVB201403‐152	2014	Crude	0.46	0.18	46
RVB201404‐164	2014	Crude	0.60	0.18	137
RVB201404‐167	2014	Crude	0.70	0.19	236
RVB201404‐170	2014	Crude	0.63	0.19	86
RVB201404‐173	2014	Crude	0.54	0.18	99
RVB201404‐197	2014	Crude	0.48	0.17	108
RVB201409‐479	2014	Crude	0.68	0.20	124
FPK201511‐419	2015	Crude	0.63	0.18	15
HSP200106‐122	2001	Chemically refined	n.a.	0.10	0.1
HSP200106‐123	2001	Physically refined	n.a.	0.11	< LOD*
AMR200309‐114	2003	Chemically refined	n.a.	0.11	< LOD*
AMR200306‐044	2003	Chemically refined	n.a.	0.14	< LOD*
MIB200301‐001	2003	Physically refined	n.a.	0.10	< LOD*
AMR200407‐090	2004	Chemically refined	0.33	0.10	n.a.
FPK200407‐095	2004	Chemically refined	< 0.3	0.10	n.a.
FPK200407‐106	2004	Chemically refined	n.a.	0.10	n.a.
FPK200407‐102	2004	Physically refined	0.43	0.12	n.a.
TEB201401‐050	2014	Physically refined	0.68	0.18	< LOD**

n.a. not analysed; LOD*: 0.03 ppm (Original dossier 2006); LOD**: 1 ppm (This dossier 2016).

Regarding the omitted iodine value, the Netherlands noted that this parameter would not provide added value. Considering that this value is an indirect parameter for the degree of the unsaturation, the Panel agrees with that view. Because of their low amounts present in the oil, the Panel has also no concerns regarding on the omission of palmitoleic acid (C16:1) and arachidic acid (C20:0). The same applies to the proposed small increase of the peroxid parameter.

Regarding the proposal to increase the specification limit for TFAs from max. 0.5 to max. 1%, the Panel notes that vegetable oils and liquid margarines have a low proportion of TFAs, usually below 1% (EFSA NDA Panel, 2004). The Panel notes the occurence of TFAs in dairy fat (i.e. around 3–6%) and the intended uses (replacing spreadable vegetable and dairy fats).

The Panel has no safety concerns regarding the proposed changes of specification parameters indicated in Table 1.

3.2. Anticipated intake/extent of use (extension of use)

The applicant applies for an extension of authorised uses of Allanblackia seed oil:

• to increase in the maximum use level in yellow fat spreads and cream‐based spreads from currently permitted 20% to 30% (w/w); and

• for the (new) use in mixes of vegetable oils and milk up to a maximum level of 30% (w/w).

For the intake assessment, the applicant used individual consumption data from the UK (NDNS 2008–2011; Table 3), the Netherlands (DNFCS‐Young Children 2005–2006, DNFCS Children‐Adults 2007–2010; Table 4) and summary statistics provided by the EFSA Comprehensive Food Consumption Database (EFSA, 2011; Table 5). The applicant estimated for the total population and for consumers only (‘all users’).

Table 3.

Summary of the estimated daily intake of Allanblackia seed oil from proposed food‐uses in the UK based on the NDNS (2008–2011) in all‐users only

Population group	Age group (Years)	% Users	Absolute consumption (g/day)			Per kg body weight consumption (mg/kg bw per day)
			Mean	Percentile		Mean	Percentile
				90	95		90	95
Toddlers	1–3	77.8	2.2	4.6	5.2	140.3	313.9	395.2
Children	4–10	81.4	3.2	6.3	7.8	126.6	264.7	342.0
Male teenagers	11–18	78.6	3.6	6.9	8.0	63.6	127.5	168.3
Female teenagers	11–18	74.9	3.1	6.0	8.4	55.9	110.0	145.8
Male adults	19–50	77.3	4.8	9.0	11.5	59.7	109.0	162.4
Female adults	19–50	75.6	3.8	8.1	9.8	55.8	116.1	145.2
Male older adults	51 +	83.5	5.6	11.4	13.9	68.0	146.2	175.6
Female older adults	51 +	83.2	4.0	8.3	10.9	57.9	124.2	153.7

bw: body weight.

Table 4.

Summary of the estimated daily intake of Allanblackia seed oil from proposed food‐uses in the Netherlands based on the Dutch National Food Consumption Surveys (DNFCS)

Population group	Age group (years)	% Users	Absolute consumption (g/day)			Per kg body weight consumption (mg/kg bw per day)
			Mean	Percentile		Mean	Percentile
				90	95		90	95
DNFCS in Young Children 2005–2006 for All‐Users
Female toddlers	2–3	91.0	3.3	6.0	8.1	224.6	383.3	542.5
Male toddlers	2–3	91.9	3.6	6.8	8.6	235.7	447.7	522.6
Female children	4–6	88.8	4.1	8.1	9.5	199.6	391.1	471.0
Male children	4–6	89.3	4.5	8.1	10.6	213.5	415.9	488.5
DNFCS Children‐Adults 2007–2010 for All‐Users
Children	7–10	87.3	5.4	10.8	11.6	177.7	329.0	386.5
Female teenagers	11–18	84.0	4.9	9.8	11.7	91.5	188.4	222.4
Male teenagers	11–18	83.2	7.1	14.1	17.5	126.3	263.7	326.9
Female Adults	19–50	82.7	6.0	11.6	14.8	83.8	172.6	211.1
Male adults	19–50	84.5	7.8	14.7	18.0	94.0	181.9	225.0
Female older adults	51–69	90.5	6.1	11.9	13.8	85.3	173.8	214.5
Male older adults	51–69	93.4	8.5	16.4	19.3	100.6	195.2	226.8

bw: body weight.

Table 5.

Estimated daily intake of Allanblackia seed oil from proposed use in margarine and cream for all‐users based on the EFSA Comprehensive Food Consumption Database

Population group	No. surveys	Absolute intakes (g/day)		Intakes expressed on body weight basis (mg/kg bw per day)
		Mean range	P95 rangea	Mean range	P95 rangea
Infants (≤ 11 months)	2	0.0–4.6	0.0–9.7	0.0–498.2	0.0–951.1
Toddlers (12–35 months)	9	1.3–6.1	1.3–12.2	83.5–491.2	83.5–1196.8
Other children (3–9 years)	17	3.0–8.6	6.3–17.7	137.2–413.3	279.1–911.7
Adolescents (10–17 years)	12	3.2–10.8	6.1–22.5	78.9–219.4	117.3–462.9
Adults (18–64 years)	15	4.1–12.9	8.2–30.2	61.1–171.6	130.6–434.2
Elderly (65–74 years)	7	3.9–15.1	10.2–33.6	58.8–211.7	147.2–485.8
Very elderly (≥ 75 years)	6	2.6–14.0	5.0–32.3	37.6–207.4	66.7–468.7

bw: body weight.

^aTotal 95th percentile intake was calculated by summing the higher 95th percentile intakes and adding the mean intake for the other food category.

Although Allanblackia seed oil is only intended for yellow fat spreads and cream‐based spreads, and for mixes of vegetable oils and milk, for the intake estimate based on UK consumption data (Table 3), the applicant considered that the NF may also be used by consumers to substitute cream for certain uses (for whipping cream, cooking cream, sour cream and crème fraiche) in addition to the intended uses.

For the intake estimate (Table 4) based on Dutch consumption data, the applicant considered that intakes can be also considered as a high intake estimate for European consumers because total fat spread consumption in the Netherlands is one of the highest in Europe (although no supporting reference was provided for that statement). Consumption data for fat spreads, mixes of vegetable oils and milk, and for cream consumption data were used from both DNFCS surveys (Young Children 2005–2006; Children‐Adults 2007–2010).

For the intake assessment based on the EFSA Comprehensive Food Consumption Database, the applicant used the consumption data for the aggregated food categories at level 2 (‘margarine and similar products’ and ‘cream and cream products’.)

In the application assessed by EFSA in 2007, the applicant had provided intake data for Germany, Sweden, the UK and the Netherlands. Among the adult male population of these countries, the Netherlands had the highest 95th percentile intake estimate (i.e. 14 g/day). For the proposed extended uses of the NF, the 95th percentile intake for the Dutch adult men population is estimated to increase (19.3 g/day; Table 4).

In the EFSA Opinion of 2007, 2.8 g/day of the NF was estimated to be consumed at the 95th percentile intake by toddlers in the UK vs 5.2 g/day when taking into account the proposed extended uses (Table 3).

3.2.1. Nutritional information

The Panel notes among the fats presented in Table 6, which could be considered to be partially replaced by the NF, Allanblackia seed oil has the lowest amount of the essential fatty acid linoleic acid (C18:2 n‐6). However, the Panel notes that vegetable oils such as corn oil, soybean oil, sunflower seed oil, and to a lesser extent rapeseed oil, are relevant sources of linoleic acid (EFSA NDA Panel, 2010). The Panel considers that the proposed extension of use of Allanblackia seed oil would not be nutritionally disadvantageous for the consumer.

Table 6.

Fatty acid profile (g/100 g) for a typical sample of refined Allanblackia seed oil compared to other edible oils

	Allanblackia seed oila	Palm kernel oilb	Coconut oilb	Butter fatc
SFA	55.0	79.8	90.5	66
MUFA	44.0	16.0	7.0	31
PUFA	1.0	2.5	1.5	3
C12:0	0.5	47.0	47.0	3
C14:0	0.2	15.0	18.0	11
C16:0	1.4	8.0	8.5	27
C16:1	0.02	0	0	2
C18:0	53.1	2.0	2.5	12
C18:1	43.6	16.0	7.0	29
C18:2	0.3	2.5	1.5	2
C18:3	0	0	0	1

SFA: saturated fatty acids; MUFA: monounsaturated fatty acids; PUFA: polyunsaturated fatty acids.

^aSee Appendix A for more compositional details of Allanblackia seed oil.

^bFatty acid profiles of palm oil, palm kernel oil and coconut oil were obtained from FEDIOL (2013).

^cButter fat fatty acid profile is taken from: Food Fats and Oils, Institute of Shortening and Edible Oils (2006).

4. Discussion

The applicant proposed some changes in the specifications of the authorised NF ‘Allanblackia seed oil’ and an increase of the maximum use level of Allanblackia seed oil in yellow fat spreads and cream‐based spreads from currently permitted 20% to 30% (w/w). The applicant also applies for the new use in mixes of vegetable oils and milk up to a maximum level of 30% (w/w). According to the information provided by the applicant, the production process and the composition of the NF do not change. The Panel notes that the revised specification limits on TFA, unsaponifiable matter, peroxide value are similar to those for other edible oils and fats.

The applicant also indicated that he had performed an updated comprehensive literature search using several different databases, but no preclinical studies or human studies on Allanblackia seed oil were identified which have not been provided for the previous EFSA assessment in 2007.

The Panel notes that the proposed extended uses would increase the potential intake of the NF, which is considered not to be nutritionally disadvantageous.

5. Conclusions

The Panel concludes that Allanblackia seed oil is safe at the extended uses and use level.

Documentation provided to EFSA

1. Application for an authorization of extension of use for Allanblackia Seed Oil in Mixes of Vegetable Oils and Milk and in Yellow Fat and Cream Based Spreads up to 30% (w/w).

2. Initial Assessment Report of the competent authority of The Netherlands.

3. Letter from the European Commission to the European Food Safety Authority with the request to carry out an additional assessment of extended uses of Allanblackia seed oil as a NF. Ref. Ares(2018)2192362, dated 25/04/2018.

Abbreviations

DNFCS

Dutch National Food Consumption Surveys

MUFA(s)

monounsaturated fatty acid(s)

NF

novel food

PUFA(s)

polyunsaturated fatty acid(s)

SFA(s)

saturated fatty acid(s)

TFA

trans‐fatty acid

Suggested citation: EFSA NDA Panel (EFSA Panel on Dietetic Products, Nutrition and Allergies) , Turck D, Bresson J‐L, Burlingame B, Dean T, Fairweather‐Tait S, Heinonen M, Hirsch‐Ernst KI, Mangelsdorf I, McArdle HJ, Naska A, Neuhäuser‐Berthold M, Nowicka G, Pentieva K, Sanz Y, Siani A, Sjödin A, Stern M, Tomé D, Vinceti M, Willatts P, Engel K‐H, Marchelli R, Pöting A, Poulsen M, Schlatter J, Gelbmann W and van Loveren H, 2018. Draft scientific opinion on the safety of Allanblackia seed oil for extended uses in vegetable oils and milk and in yellow fat and cream‐based spreads up to 30% (w/w). EFSA Journal 2018;16(8):5362, 11 pp. 10.2903/j.efsa.2018.5362