Scientific Opinion on the safety and efficacy of sodium carbonate (soda ash) for all species 1

Transcription

1 SCIENTIFIC OPINION Scientific Opinion on the safety and efficacy of sodium carbonate (soda ash) for all species 1 EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) 2,3 European Food Safety Authority (EFSA), Parma, Italy SUMMARY Following a request from the European Commission, the European Food Safety Authority was asked to deliver a scientific opinion on the safety and efficacy of sodium carbonate (soda ash) used as technological feed additive (functional group acidity regulator) for all animal species. It is an approved food additive without restrictions. On the basis of the existing use in food, the Panel on Additives and Products or Substances used in animal Feed (FEEDAP) concludes that sodium carbonate is safe for all animal species, the consumers and the users. At levels typically used in animal feed, sodium carbonate is not expected either to pose a risk for the environment. Sodium carbonate is a well-known component of many buffer solutions. However, the relevance of its buffering capacity in feed materials is not demonstrated. KEY WORDS Technological additive, acidity regulator, sodium carbonate, soda ash, safety, efficacy 1 On request from European Commission, Question No EFSA-Q , adopted on 13 July Panel members: Gabriele Aquilina, Georges Bories, Paul Brantom, Andrew Chesson, Pier Sandro Cocconcelli, Joop de Knecht, Noël Albert Dierick, Mikolaj Antoni Gralak, Jürgen Gropp, Ingrid Halle, Reinhard Kroker, Lubomir Leng, Sven Lindgren, Anne-Katrine Lundebye Haldorsen, Alberto Mantovani, Miklós Mézes, Derek Renshaw and Maria Saarela Correspondence: FEEDAP@efsa.europa.eu 3 Acknowledgement: The Panel wishes to thank the members of the Working Group on Technological Additives, including Bogdan Debski, for the preparation of this opinion. Suggested citation: EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP); Scientific Opinion on the safety and efficacy of sodium carbonate (soda ash) for all species.. [8 pp.]. doi: /j.efsa Available online: European Food Safety Authority,

2 TABLE OF CONTENTS Summary... 1 Key words... 1 Table of contents... 2 Background... 3 Terms of reference... 3 Assessment Introduction Characterisation Characterisation of the product Stability and homogeneity Conditions of use Evaluation of the analytical methods by the Community Reference Laboratory (CRL) Safety Safety for the target species Safety for the consumer and user Safety for the environment Efficacy... 6 Conclusions and recommendations... 6 Documentation provided to EFSA... 6 References

3 BACKGROUND Regulation (EC) No 1831/ establishes the rules governing the Community authorisation of additives for use in animal nutrition. In particular, Article 4(1) of that Regulation lays down that any person seeking authorisation for a feed additive or for a new use of a feed additive shall submit an application in accordance with Article 7. The European Commission received a request from the company EuSalt aisbl 5 for authorisation of the product sodium carbonate (soda ash) to be used as a feed additive for all species (category: technological additive; functional group: acidity regulator) under the conditions mentioned in Table 1. 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 4(1) (authorisation of a feed additive or new use of a feed additive). EFSA received directly from the applicant the technical dossier in support of this application. 6 According to Article 8 of that Regulation, 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. The particulars and documents in support of the application were considered valid by EFSA as of 17 July The additive is a chemically synthesised sodium carbonate. This product is currently authorised for its use in dogs and cats (E 500(i)) (authorisation to expire on 7 November 2010). TERMS OF REFERENCE According to Article 8 of Regulation (EC) No 1831/2003, EFSA shall 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 the efficacy of the product sodium carbonate (soda ash), when used under the conditions described in Table OJ L 268, , p. 29. Avenue de l Yser 4, B-1040, Brussels, Belgium. EFSA Dossier reference: FAD

4 Table 1: Description and conditions of use of the additive as proposed by the applicant Additive Registration number/ec No/No (if appropriate) Category(ies) of additive Functional group(s) of additive Sodium Carbonate E500(i) Technical additive Acidity regulator Composition, description Chemical formula Description Purity criteria (if appropriate) Method of analysis (if appropriate) Sodium Carbonate Na2CO3 Technical grade ph-titration Trade name (if appropriate) Name of the holder of authorisation (if appropriate) Soda Ash EuSalt aisbl Species or category of animal Maximum Age Conditions of use Minimum content Maximum content mg/kg of complete feedingstuffs Withdrawal period (if appropriate) All species or categories of not relevant not relevant animals Other provisions and additional requirements for the labelling Specific conditions or restrictions no specific conditions for use (if appropriate) Specific conditions or restrictions no specific conditions for handling (if appropriate) Post-market monitoring (if not relevant appropriate) Specific conditions for use in complementary feedingstuffs not relevant (if appropriate) Marker residue Maximum Residue Limit (MRL) (if appropriate) Species or category of animal Target tissue(s) or food products Maximum content in tissues Not relevant Not relevant Not relevant Not relevant 4

5 ASSESSMENT 1. Introduction Sodium carbonate is currently authorised as a feed additive (acidity regulator) for dogs and cats by Directive 70/524/EEC 7 without maximum content and age limit for those animal species. The present application relates to the use of sodium carbonate in all animal species as a technological additive, functional group acidity regulator. Sodium carbonate is authorised without maximum content for use in food (Regulation 1925/2006/EC) 8 and food supplements (Directive 2002/46/EC). 9 It is also used in cosmetics, soaps, scouring powders, soaking and washing powders. 2. Characterisation 2.1. Characterisation of the product The product consists of sodium carbonate (synonym soda ash, CAS N ), without carrier materials. The additive is specified to contain 99.5 % sodium carbonate, 0.15 % sodium chloride, 0.02 % sodium sulphate, % calcium oxide, % magnesium oxide and % iron (III) oxide. The minimum content of sodium carbonate in the additive is confirmed by the analyses of five batches (range %). 10 Five batches of the product were within the specifications of the Food Chemicals Codex (2003) for heavy metals and arsenic. 11 In three batches 12 PCBs contents were below the detection limits (50 ng/kg), dioxins were found in a range of 6.0 to 6.4 ng PCDD/PCDF WHO-TE/kg. The additive is an odourless white powder with 2 % particles larger than 1 mm and 8 % particles smaller than 125 µm, 1.12 % smaller than 100 μm, 0.45 % smaller than 50 μm and 0.29 % smaller than 10 μm, as an average of five batches. 13 The additive is synthesised by the Solvay process using limestone (CaCO 3 ) and brine (NaCl) as starting materials Stability and homogeneity The assessment of the shelf life of inorganic mineral salts like sodium carbonate is not necessary, since those compounds are generally recognised as stable. No data have been submitted to support the stability of the additive in feedingstuffs, but it is not expected to degrade in dry feedingstuffs. Similarly, no evidence has been provided on the capacity of the additive to homogeneously distribute in feedingstuffs. However, the particle size distribution of the additive would probably allow a homogeneous distribution in complete and complementary feedingstuffs (also in livestock feed salt) at the proposed dose range (up to 400 mg/kg). 7 OJ L 270, , p OJ L 404, , p OJ L 183, , p Technical dossier, Supplementary Information, Section II, Annex II_1. 11 Technical dossier, Supplementary Information, Section II, Annex II_2. 12 Technical dossier, Supplementary Information, Section II, Annex II_3. 13 Technical dossier, Supplementary Information, Section II, Annex II_4 and 5. 5

6 2.3. Conditions of use The additive is intended to be used in all animal species/categories (without limitations for age) and without withdrawal period. The applicant recommends to set a maximum content of 400 mg/kg in feed grade salt Evaluation of the analytical methods by the Community Reference Laboratory (CRL) EFSA has verified the CRL report as it relates to the methods used for the control of the active substance in animal feed. The Executive Summary of the CRL report can be found in the Appendix. 3. Safety 3.1. Safety for the target species After intestinal absorption, sodium carbonate provides sodium and CO 3 /HCO 3 ions to the metabolic pathways and body pools. It has limited effect on the acid/base homeostasis in animals. Sodium, as well as CO 2 /HCO 3, is rapidly excreted with water via kidneys (and also faeces and skin) and via respiration, respectively. Sodium carbonate is authorised for use in food without any restriction. A food additive is generally assumed to be also safe for target animals if the intake is not considerably higher than in humans. Because no upper limit for humans exists, a calculation cannot be made, but there is no reason to assume that it would not be safe for the target animals at the levels typically used in animal feed. The FEEDAP Panel concludes that sodium carbonate is safe for all animal species at practical use levels Safety for the consumer and user According to Regulation (EC) No 429/2008, studies concerning the safety for the consumers and the users are generally not necessary for an additive, like sodium carbonate, which is already approved as food additive without any restriction Safety for the environment At levels typically used in animal feed sodium carbonate is not expected to pose a risk for the environment. 4. Efficacy Sodium carbonate is a well-known component of many buffer solutions. However, the relevance of its buffering capacity in feed materials is not demonstrated. CONCLUSIONS AND RECOMMENDATIONS CONCLUSIONS The FEEDAP Panel concludes that sodium carbonate is safe for all animal species, the consumers, the users and the environment. Sodium carbonate is a well-known component of many buffer solutions. However, the relevance of its buffering capacity in feed materials is not demonstrated. DOCUMENTATION PROVIDED TO EFSA 1. Soda ash (sodium carbonate). October Submitted by EuSalt aisbl. 2. Soda ash. Supplementary information. May Submitted by EuSalt aisbl. 6

7 3. Evaluation report of the Community Reference Laboratory for Feed Additives on the methods(s) of analysis for sodium carbonate (Soda ash). 4. Comments from Member States received through the ScienceNet. REFERENCES Food Chemical Codex (FCC), Food Chemicals Codex, 5th ed. National Academy of Sciences Press. 7

8 APPENDIX Executive Summary of the Evaluation Report of the Community Reference Laboratory for Feed Additives on the Method(s) of Analysis for sodium carbonate (Soda ash) In the current application authorisation is sought for Sodium Carbonate under the category technological additives, functional group 1(j) as an acidity regulator for all animal species, according to Annex I of Regulation (EC) No 1831/2003. The active agent is sodium carbonate of technical grade with a minimum purity of 99.5%. It is intended to be marketed as a white odourless powder to be incorporated into premixtures and/or complete feedingstuffs to obtain a maximum recommended dosage of sodium carbonate of 400 mg/kg of feedingstuffs for all animal species. For the determination of sodium carbonate in feed additives the applicant proposes the international standard method ISO 740:1976. The method is based on a titrimetric assay for the determination of total soluble alkalinity of sodium carbonate for industrial use. The CRL recommends this ISO method for official controls for the determination of sodium carbonate in feed additives. The unambiguous determination of the content of exogenous sodium carbonate added to the premixtures and the feedingstuffs is not achievable by analysis. Nevertheless, several analytical methods are available for the determination of total sodium and total carbonates in premixtures and in feedingstuffs. Among them, the CRL recommends two international standard methods for official controls: - CEN method EN 15510:2008 for the determination of total sodium and - Community method (Regulation (EC) No 152/2009) for the determination of total carbonates. Further testing or validation is not considered necessary. 8