Butylated hydroxyanisole (BHA) is a waxy solid consisting for > 98.5% of the active substance, a mixture of 3‐tert‐butyl‐4‐hydroxyanisole and 2‐tert‐butyl‐4‐hydroxyanisole. It is intended to be used as an antioxidant in feedingstuffs for all animal species and categories. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considered BHA up to 150 mg/kg complete feed as safe for all animal species except for cats, for which a safe dose could not be established from the tolerance data. BHA is rapidly absorbed from the gastrointestinal tract; it is metabolised rapidly and excreted as such and as metabolites in the urine and faeces. The proportions of the different metabolites vary depending on species and dose. No accumulation of BHA or metabolites was observed in tissues. The Panel concluded that no concern for consumer safety would arise from the use of BHA as a feed additive at the maximum concentration of 150 mg/kg feed. The additive should be considered a skin, eye irritant and a potential skin sensitiser. Exposure of the user via inhalation was considered unlikely; therefore, a risk is not expected. The use of BHA at the maximum concentration proposed is unlikely to pose a risk to the environment. BHA is authorised as an antioxidant for food use at comparable use levels, therefore, no studies were required to demonstrate the efficacy of BHA as an antioxidant in feedingstuffs for all animal species.

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of butylated hydroxyanisole (BHA) as a feed additive for all animal species.

Butylated hydroxyanisole (BHA) is a waxy solid consisting for > 98.5% of the active substance, a mixture of 3‐tert‐butyl‐4‐hydroxyanisole and 2‐tert‐butyl‐4‐hydroxyanisole. It is intended to be used as an antioxidant in feedingstuffs for all animal species and categories except dogs with a maximum content of 150 mg/kg complete feedingstuffs (alone or together with butylated hydroxytoluene (BHT) (E 321) and/or ethoxyquin (E 324)) and for dogs with a maximum content of 150 mg/kg complete feedingstuffs (alone or together with BHT (E 321))

Although (i) the classical tolerance study in chickens for fattening shows some weaknesses in experimental design and reduced sensitivity due to low body weight gain, (ii) the other studies, available only as publications and not as full report, were not designed as tolerance studies, and (iii) some uncertainties remain on the extrapolation of the data to all animal species, a weight of evidence of the limited data supports that 150 mg BHA/kg complete feed would be a safe dose for all animal species. However, a possible exception could be cat, with its known lower capacity for glucuronidation of phenolic compounds and for which no specific data were available.

BHA is rapidly absorbed from the gastrointestinal tract; it is metabolised rapidly and excreted as such and as metabolites in the urine and faeces. The proportions of the different metabolites vary depending on species and dose. No accumulation of BHA or metabolites was observed in tissues. The FEEDAP Panel retains the acceptable daily intake (ADI) of 1 mg/kg body weight (bw) proposed by the EFSA Scientific Panel on Additives and Nutrient Sources added to Food (ANS).

A highly conservative estimate of consumer exposure resulting from consumption of food from animals fed BHA at the highest feed concentration of 150 mg BHA/kg resulted in 5 mg BHA per person per day, corresponding to about 8% of the ADI. The FEEDAP Panel concludes that no concern for consumer safety would arise from the use of BHA as a feed additive at the maximum concentration of 150 mg/kg feed.

The additive should be considered a skin, eye irritant and a potential skin sensitiser. Exposure of the user via inhalation is considered unlikely; therefore, a risk is not expected.

The use of BHA at the maximum concentration proposed is unlikely to pose a risk to the environment.

Since BHA is authorised as an antioxidant for food use at comparable use levels, no studies are required to demonstrate the efficacy of BHA as an antioxidant in feedingstuffs for all animal species.

Regulation (EC) No 1831/20031 establishes the rules governing the Community authorisation of additives for use in animal nutrition. In particular, Article 10(2) of that Regulation also specifies that for existing products within the meaning of Article 10(1), an application shall be submitted in accordance with Article 7, at the latest one year before the expiry date of the authorisation given pursuant to Directive 70/524/EEC for additives with a limited authorisation period, and within a maximum of 7 years after the entry into force of this Regulation for additives authorised without a time limit or pursuant to Directive 82/471/EEC.

The European Commission received a request from FEFANA asbl2 for re‐evaluation of the authorisation of the product Butylated Hydroxy Anisole (BHA), when used as a feed additive for all animal species (category: technological additive; 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) as an application under Article 10(2) (re‐evaluation of an authorised feed additive). EFSA received directly from the applicant the technical dossier in support of this application. The particulars and documents in support of the application were considered valid by EFSA as of 13 September 2011.

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 product Butylated Hydroxy Anisole (BHA), when used under the proposed conditions of use (see Section 3.1.2).

The additive BHA is currently authorised as a technological additive in feedingstuffs for all animal species (in application of Article 9t (b) of Council Directive 70/524/EEC concerning additives in feedingstuffs (2004/C 50/01)) with a maximum content of 150 mg/kg complete feedingstuffs alone or together with butylated hydroxytoluene (BHT) (E 321) and/or ethoxyquin (E 324) (only for dogs: alone or in combination with E 321).

BHA is authorised according to Directive 95/2/EC1 as a food additive (antioxidant), up to a maximum level of 400 mg/kg.

The Scientific Committee on Food (SCF), the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and EFSA ANS Panel have delivered several opinions on the use of BHA as a food additive (JECFA, 1974, 1976, 1982, 1986, 1987, 1989, 1999, 2006; SCF, 1989; EFSA ANS Panel, 2011, 2012).

The present assessment is based on data submitted by the applicant in the form of a technical dossier3 in support of the authorisation request for the use of BHA as a feed additive. The technical dossier was prepared following the provisions of Article 7 of Regulation (EC) No 1831/2003, Regulation (EC) No 429/20084 and the applicable EFSA guidance documents.

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 and other scientific reports to deliver the present output.

EFSA has verified the European Union Reference Laboratory (EURL) report as it relates to the methods used for the control of the BHA in animal feed. The Executive Summary of the EURL report can be found in Annex A.5

The approach followed by the FEEDAP Panel to assess the safety and the efficacy of BHA is in line with the principles laid down in Regulation (EC) No 429/2008 and the relevant guidance documents: Guidance on technological additives (EFSA FEEDAP Panel, 2012a), Technical guidance: Tolerance and efficacy studies in target animals (EFSA FEEDAP Panel, 2011a), Technical Guidance for assessing the safety of feed additives for the environment (EFSA, 2008a), Guidance for the preparation of dossiers for the re‐evaluation of certain additives already authorised under Directive 70/524/EEC (EFSA, 2008b), Guidance for the preparation of dossiers for additives already authorised for use in food (EFSA FEEDAP Panel, 2012b), Guidance for establishing the safety of additives for the consumer (EFSA FEEDAP Panel, 2012c), Guidance on studies concerning the safety of use of the additive for users/workers (EFSA FEEDAP Panel, 2012d), Guidance on the assessment of additives intended to be used in pets and other non food‐producing animals (EFSA FEEDAP Panel, 2011b)and Technical Guidance: Extrapolation of data from major species to minor species regarding the assessment of additives for use in animal nutrition (EFSA, 2008c).

The additive under assessment is mainly composed of the active substance BHA. It is intended to be used as a feed additive (category: technological additives; functional group: (b) antioxidants) in feedingstuffs for all animal species.

The additive BHA is produced by the reaction of tert‐butylhydroquinone with dimethyl sulfate and sodium hydroxide; it is then purified with n‐hexane, filtered and crystallised in the form of flakes; it is a waxy solid at room temperature.

The additive is equivalent to the active substance, a mixture of 2‐tert‐butyl‐4‐hydroxyanisole and 3‐tert‐butyl‐4‐hydroxyanisole (Figures 1 and ​and2).2). It is specified to contain at least 98.5% of BHA (IUPAC name: 2‐tert‐butyl‐4‐hydroxyanisole and 3‐tert‐butyl‐4‐hydroxyanisole, Chemical Abstracts Service (CAS) number 25013‐16‐5, chemical formula C11H16O2, and molecular weight 180.25) and not less than 85% of the 3‐tert‐butyl‐4‐hydroxyanisole isomer. The same specifications are set by the Commission Regulation (EU) No 231/20126 for its use as a food additive.

3‐tert‐butyl‐4‐hydroxyanisole

2‐tert‐butyl‐4‐hydroxyanisole

The analysis of nine batches of the additive from two producers showed concentrations of BHA ≥ 99.3% of which ≥ 90.0% 3‐tert‐butyl‐4‐hydroxyanisole isomer,7 in compliance with the specifications. The impurities analysed (sulfated ash, phenolic impurities and arsenic in nine batches, and mercury in three batches)7 showed concentrations in compliance with the specifications for the food additive (sulfated ash