EUROPEAN COMMISSION IMPLEMENTING REGULATION

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COMMISSION IMPLEMENTING REGULATION (EU) 2017/66

of 14 December 2016

concerning the authorisation of tannic acid as a feed additive for all animal species

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,

Whereas:

饲用单宁酸

(1)	Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

(2)	Tannic acid was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for all animal species. That product was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.

(3)

In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of tannic acid as a feed additive for all animal species. The applicant requested that additive to be classified in the additive category ‘sensory additives’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

(4)

The European Food Safety Authority (‘the Authority’) concluded in its opinion of 11 September 2014 (3) that, under the proposed conditions of use in feed this substance does not have adverse effects on animal health, human health or the environment. The Authority further concluded that the function of tannic acid in feed is similar to that on food. The Authority has already concluded that for food tannic acid is efficacious, as it increases the food smell or palatability. Therefore, that conclusion can be extrapolated for feed.

(5)

Restrictions and conditions should be provided for to allow better control. Since safety reasons do not require the setting of a maximum content and taking into account the re-evaluation performed by the Authority, a recommended content should be indicated on the label of the additive. Where such content is exceeded, certain information should be indicated on the label of premixtures, compound feeds and feed materials.

(6)

The Authority concluded that in the absence of data on user safety tannic acid should be considered as potentially hazardous to the respiratory tract, skin, eyes and mucous membranes. Consequently, appropriate protective measures should be taken. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(7)	The assessment of the substance concerned shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of tannic acid should be authorised as specified in the Annex to this Regulation.

(8)	Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for tannic acid, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

(9)	The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Authorisation

The substance specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, is authorised as a feed additive in animal nutrition subject to the conditions laid down in that Annex.

Article 2

Transitional measures

1. The substance specified in the Annex and premixtures containing those substances, which are produced and labelled before 6 August 2017 in accordance with the rules applicable before 6 February 2017 may continue to be placed on the market and used until the existing stocks are exhausted.

2. Compound feed and feed materials containing the substance as specified in the Annex which are produced and labelled before 6 February 2018 in accordance with the rules applicable before 6 February 2017 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.

3. Compound feed and feed materials containing the substance as specified in the Annex which are produced and labelled before 6 February 2019 in accordance with the rules applicable before 6 February 2017 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.

Article 3

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 14 December 2016.

For the Commission

The President

Jean-Claude JUNCKER

(1) OJ L 268, 18.10.2003, p. 29.

(2) Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).

(3) EFSA Journal 2014;12(10):3828.

ANNEX

ANNEX
Identification number of the additive

Name of the holder of authorisation

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation
mg of active substance/kg of complete feedingstuff with a moisture content of 12 %
Category: Sensory additives. Functional group: Flavouring compounds
2b16080

Tannic acid

Additive composition
Tannic acid
Characterisation of the active substance
Tannic acid
Produced by extraction from different plants.
Purity: min. 93 % on dry matter basis
Chemical formula: C76H52O46
CAS number 72401-53-7
FLAVIS No: 16.080
Method of analysis (1)
For the determination of tannic acid, in the feed additive:
Qualitative colorimetric or precipitation tests (Ph. Eur. 6th edition, monograph 1477) and quantitative gravimetric method (FAO JECFA tannic acid monograph).
For the identification of tannic acid (as gallic acid) in the premixture of flavourings:
Reversed Phase High Performance Liquid Chromatography coupled to UV detector(RP-HPLC-UV).

All animal species

The additive shall be incorporated into the feed in the form of a premixture.
2.

In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.
3.

The recommended maximum content of the active substance shall be: 15 mg/kg of complete feedingstuff with a moisture content of 12 %.
4.

On the label of the additive, the following shall be indicated:
‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %:15 mg/kg’.
5.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 15 mg/kg.饲用单宁酸
6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including safety glasses and gloves.

(1) Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports

17_0927_00_e

The Effects of Tannins in Monogastric Animals with Special Reference to Alternative Feed Ingredients

2021年1月3日没有评论

饲用单宁酸Abstract: Over recent years, the monogastric animal industry has witnessed an increase in feed prices due to several factors, and this trend is likely to continue. The hike in feed prices is mostly due to extreme competition over commonly used conventional ingredients. For this trend to be subdued, alternative ingredients of both plant and animal origin need to be sourced. These types of ingredients are investigated with the aim of substituting all or some of the conventional compounds. However, alternative ingredients often have a double-edged sword effect, in that they can supply animals with the necessary nutrients although they contain antinutritional factors such as tannins. Tannins are complex secondary metabolites commonly present in the plant kingdom, known to bind with protein and make it unavailable; however, recently they have been proven to have the potential to replace conventional ingredients, in addition to their health benefits, particularly the control of zoonotic pathogens such as Salmonella. Thus, the purpose of this review is to (1) classify the types of tannins present in alternative feed ingredients, and (2) outline the effects and benefits of tannins in monogastric animals. Several processing methods have been reported to reduce tannins in diets for monogastric animals; furthermore, these need to be cost-effective. It can thus be concluded that the level of inclusion of tannins in diets will depend on the type of ingredient and the animal species.单宁酸

单宁酸产品特性

2021年1月3日没有评论

来源于天然植物提取的单宁酸，具有良好的抗腹泻、抗菌、抗氧化、抗寄生虫等功效，能够改善畜禽生长性能，提高饲料利用率，减少抗生素和氧化锌的使用，提高动物整体的健康程度及动物性产品的安全性。

What is tannic acid?

2021年1月3日没有评论

单宁酸具有抗氧化作用，是一种天然的防腐剂，能有效避免红酒被氧化变酸，使长期储存的红酒能保持最佳状态。最近的研究发现，单宁对预防和治疗心血管疾病有较好的效果。心脑血管疾病仍是威胁人类健康的头号杀手，所以中老年人坚持每天喝适量的葡萄酒进行自我保健是一个很好的方法。另外，现在很多年轻人工作压力大，精神压力大，很多人都处于亚健康状态。因此，年轻人最好也养成喝红酒的习惯，这样可以安抚神经，缓解压力。

单宁酸及其与不同有机氮化合物和酶的复杂相互作用:旧的范式与新的进展对比

2020年5月28日没有评论

单宁与蛋白质之间的相互作用已经研究了50多年，因为其独特的特性和在食品工业和药理学中的潜在用途。然而，随着单宁酸浓度对酶的调控以及与其他非蛋白氮化合物的潜在相互作用的新见解的提出，未来的研究还需要进行。应特别注意使用纯化和表征良好的单宁，因为植物提取物中多酚的化学成分和其他化合物的存在可能会显著影响单宁与氮化合物的相互作用。后续研究的目的应该是将这些结果推导到更复杂的、异质的、现实的体系中。总之，研究单宁酸与蛋白质之间的相互作用，以及其他有机化合物之间的相互作用的研究很可能会引起人们的极大关注，因为人们对多酚类化合物在人类健康和疾病治疗方面的普遍兴趣，同时也对其在饮料和食品工业中的作用产生了浓厚的兴趣。

Tannins and Their Complex Interaction with Different Organic Nitrogen Compounds and Enzymes: Old Paradigms versus Recent Advances

2020年5月28日没有评论

Interactions between tannins and proteins have been studied for more than 50 years, because of their unique characteristics and potential use in food industry and pharmacology. However, with the new insights regarding regulation of enzymes by tannin concentration and the potential interaction with other non‐protein N compounds, future studies are needed. Special attention should be paid to the use of well‐purified and characterized tannins, because the chemistry of polyphenols and the presence of other compounds in plant extracts may significantly affect tannin interactions with N compounds. Follow‐up studies should aim to extrapolate these results to more complex, heterogenic, realistic systems. In conclusion, studies investigating the interactions between tannins and proteins, but also other organic compounds, are likely to attract significant attention due to the general interest in polyphenols with regard to human health and disease treatment, but also their role in the beverage and food industry.

水解单宁对常见鱼类病原体的体外活性

2020年5月17日没有评论

这项体外研究表明，Silvafeed TSP(饲用单宁酸）对常见的细菌鱼病原体（如李斯特菌，鼠疫耶尔森菌和沙门氏菌气单胞菌）具有很强的抗菌作用，在所有研究的剂量水平下，对沙门氏杆菌都有较强的抗菌效果，而对水生单胞菌有中等的效果，在较高的剂量范围内（0.40％和0.50％），对乳球菌和鲑鱼阴道球菌有轻微的效果。