Abstract
OptiPhos® is the trade name of the feed additive under assessment containing 6‐phytase produced by a genetically modified strain of Komagataella phaffii. It is authorised for use in chickens for fattening and reared for laying, turkeys for fattening and reared for breeding, other avian species for fattening, laying hens, weaned piglets, pigs for fattening and sows. This scientific opinion concerns the request for the renewal of the authorisation of the additive for the species/categories for which there is an authorisation and the extension of use to breeding hens, turkeys for breeding purposes, ornamental birds, minor pig species for fattening or breeding and suckling piglets for the period when solid feed is given. The applicant provided evidence that the additive currently in the market complies with the conditions of the authorisation. There is no new evidence that would lead the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) to reconsider previous conclusions that the additive remains safe for the animal species/categories, the consumer and the environment under the authorised conditions of use. This conclusion applies also to the new target species/categories for which a request of extension of use is made. The additive is not irritant to skin or eyes but should be considered a respiratory sensitiser. There was no need for assessing the efficacy of the additive for the authorised species/categories. The additive has the potential to be efficacious at 125 OTU/kg complete feed in all poultry species other than turkeys, ornamental birds, pigs for fattening, sows and minor pig species for fattening or breeding; and in turkeys for fattening, reared for breeding and for breeding purposes, weaned piglets and suckling piglets (for the period when solid feed is given) at 250 OTU/kg feed.
Keywords: zootechnical additives, digestibility enhancers, 6‐phytase, OptiPhos® , renewal, poultry, pigs
1. Introduction
1.1. Background and Terms of Reference
Regulation (EC) No 1831/2003 1 establishes the rules governing the Community authorisation of additives for use in animal nutrition. In particular, Article 14(1) of that Regulation lays down that an application for renewal shall be sent to the Commission at the latest one year before the expiry date of the authorisation; whereas Article 4(1) of that Regulation lays down that any person seeking authorisation for a feed additive or for a new use of feed additive shall submit an application in accordance with Article 7.
The European Commission received a request from (Huvepharma EOOd) 2 for the renewal of the authorisation of the additive consisting of 6‐phytase produced by Komagataella phaffii DSM 23036 (OptiPhos®) when used as a feed additive for chickens for fattening, turkeys for fattening, other avian species for fattening, turkeys reared for breeding, chickens reared for laying, laying hens, weaned piglets, pigs for fattening, sows; and an extension of use when used for breeding hens, turkeys for breeding purposes, ornamental birds, minor pig species for fattening or breeding and suckling piglets (category: zootechnical additives; functional group: digestibility enhancers).
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 14(1) (renewal of the authorisation) and 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. The particulars and documents in support of the application were considered valid by EFSA as of 23 April 2021.
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 feed additive consisting 6‐phytase produced by Komagataella phaffii DSM 23036 (OptiPhos®) when used under the proposed conditions of use (see Section 3.1.1 ).
1.2. Additional information
The Panel on Additives and Products or Substances in Animal Feed (FEEDAP) issued two opinions on the safety and efficacy of this product as a feed additive for chickens and turkeys for fattening, chickens reared for laying, turkeys reared for breeding, laying hens, other birds for fattening and laying, weaned piglets, pigs for fattening and sows (EFSA FEEDAP Panel, 2011) and for finfish (EFSA FEEDAP Panel, 2017a); and another on the modification of the terms of the authorisation for pigs for fattening (EFSA FEEDAP Panel, 2015).
The additive is currently authorised for use in feed for all poultry species for fattening and reared for laying/breeding, laying hens, weaned piglets, pigs for fattening, sows and fish (4a16). 3
2. Data and methodologies
2.1. Data
The present assessment is based on data submitted by the applicant in the form of a technical dossier 4 in support of the authorisation request for the use 6‐phytase produced by Komagataella phaffii DSM 23036 (OptiPhos®) as a feed additive.
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 and peer‐reviewed scientific papers to deliver the present output.
The European Union Reference Laboratory (EURL) considered that the conclusions and recommendations reached in the previous assessment regarding the methods used for the control of the 6‐phytase produced by Komagataella phaffii DSM 23036 in animal feed are valid and applicable for the current application. 5
2.2. Methodologies
The approach followed by the FEEDAP Panel to assess the safety and the efficacy of 6‐phytase produced by Komagataella phaffii DSM 23036 (OptiPhos®) is in line with the principles laid down in Regulation (EC) No 429/2008 6 and the relevant guidance documents: Guidance on the identity, characterisation and conditions of use of feed additives (EFSA FEEEDAP Panel, 2017b); Guidance on the assessment of the safety of feed additives for the target species (EFSA FEEDAP Panel, 2017c); Guidance on the assessment of the efficacy of feed additives (EFSA FEEDAP Panel, 2018a); Guidance on the characterisation of microorganisms used as feed additives or as production organisms (EFSA FEEDAP Panel, 2018b); Guidance on the renewal of the authorisation of feed additives (EFSA FEEDAP Panel, 2013).
3. Assessment
The present assessment regards the renewal of the authorisation of the additive consisting of 6‐phytase (EC 3.1.3.26) produced by Komagataella phaffii DSM 23036 for chickens for fattening and reared for laying, turkeys for fattening and reared for breeding, other avian species for fattening, laying hens, weaned piglets, pigs for fattening and sows.
The assessment also regards the request for an extension of use to breeding hens, turkeys for breeding purposes, ornamental birds, minor pig species for fattening or breeding and suckling piglets for the period when solid feed is given.
The product under assessment will be hereafter referred to with its trade name: OptiPhos®.
3.1. Characterisation
The applicant declared that no changes in the manufacturing process and composition of the additive have been applied since the authorisation of the product.
Three formulations are described by the applicant: OptiPhos® 4000 G (solid, granulated) contains the solid enzyme concentrate and pregelatinised starch (~ 1%) and wheat flour (~ 80%), with a minimum activity of 4,000 OTU 7 /g; OptiPhos® 4,000 CT (solid, coated) contains the solid enzyme concentrate and pregelatinised starch (5%), distilled monoglyceride (13.5%), palm oil (13.5%), corn grids (0–20%) and wheat meal (38%), with a minimum activity of 4,000 OTU/g; and OptiPhos® 8,000 L (liquid) contains 20% of the liquid enzyme concentrate and sucrose (30%), sodium benzoate (0.5%) and water (purified, up to 100%), with a minimum activity of 8,000 OTU/g.
Analytical data to confirm the specifications were provided for eight batches of the 4,000 G and for nine batches of the 4,000 CT and 8,000 L formulations of the additive, 8 showing the following average values (in OTU/g): 4,624 (range 4,570–4,680) for 4,000 G; 4,583 (range 4,420–4,720) for 4,000 CT; and 8,607 (range 8,400–8,880) for 8,000 L.
Four batches of each formulation of the additive were analysed for the presence of arsenic, lead, cadmium, mercury and mycotoxins. 9 All values fell below the respective limit of quantification (LOQ) 10 for OptiPhos® 4,000 G and 8,000 L, except for cadmium in 4,000 G, which showed an average value of 0.024 (range 0.022–0.026) mg/kg. The analysed batches of Optiphos® 4,000 CT showed contents of arsenic (0.123 mg/kg) and lead (0.2 mg/kg) only in one of the analysed batches, whereas the content of mercury and cadmium fell below the LOQ in all cases. The only mycotoxins detected in 4,000 CT were: zearalenone, with an average value of 42.9 (range 15.2–77.7) µg/kg; deoxynivalenol with 282 (range < 100–316) µg/kg and fumonisins (B1 + B2), which were only detected in one batch, with a content of 231.6 µg/kg.
Polychlorinated dibenzodioxins (PCDDs), polychlorinated dibenzofurans (PCDFs) and coplanar dioxin‐like polychlorinated biphenyls (co‐planar PCBs) were analysed in only one batch of each formulation. 11 The calculated (upper bound) levels of dioxins and the sum of dioxins and dioxin‐like‐PCBs were 0.137, 0.124 and 0.252 ng WHO‐PCDD/F‐TEQ/kg and 0.269, 0.244 and 0.495 ng WHO‐PCDD/F‐PCB‐TEQ/kg, for the OptiPhos® 4,000 G, 4,000 CT and 8,000 L, respectively.
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The microbiological contamination was evaluated in three batches of each form of the additive. 15 Enterobacteriaceae and Salmonella spp. (in 25 g) were not detected in any batch of any formulation. Total yeasts and filamentous fungi showed an average value of 3.36 (range 3.26–3.48) log colony forming units (CFU)/g in 4,000 G, 3.65 (range 3.61–3.70) log CFU/g in 4,000 CT and were not detected in any batch of 8,000 L.
The presence of viable cells and DNA of the production strain was investigated in a liquid concentrate, common intermediate for the different formulations, which would allow conclusions in the three different final formulations. The potential presence of viable cells of the production strain in OptiPhos® was evaluated in a study performed on three batches in triplicate, 16 by plating 10 mL of 6‐phytase liquid concentrate (40,000 OTU/g) on yeast dextrose broth agar plates ■■■■■ at 30°C for 3 days. No viable cells of the production strain were detected.
The potential presence of recombinant DNA of the production strain in the additive was investigated by polymerase chain reaction (PCR) analysis of three batches in triplicate. 17 DNA was extracted from 1 mL of 6‐phytase liquid concentrate with a method that included a lysis step. Appropriate positive and negative controls were included. No DNA was detected with primers that would amplify the 290 bp fragment specific for ■■■■■, with a limit of detection of 10 ng/mL spiked DNA/mL of 6‐phytase liquid concentrate.
The detected amounts of the above impurities do not raise safety concerns.
No new data have been provided regarding the physico‐chemical properties or stability of the additive. Since no changes have been introduced in the additive or its manufacturing process, the data described in previous opinions still apply.
The production strain is a genetically modified strain of Komagataella phaffii, deposited at the Deutsche Sammlung von Mikroorganismen und Zellkulturen with the accession number DSM 23036 (deposited as Pichia pastoris). 18 The whole genome sequence (WGS) of the production strain DSM 23036 was obtained using short and long reads sequencing technologies. The WGS analysis allowed to achieve the taxonomical identification, by comparing the four chromosome sequences of the production strain with those of the parental strain ■■■■■ Single‐nucleotide polymorphisms (SNPs) analysis of WGS data confirms the identification of the production strain as K. phaffii.
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3.1.1. Conditions of use
The additive is currently authorised for use in feed for chickens for fattening, chickens reared for laying, laying hens, other avian species other than turkeys for fattening, pigs for fattening and sows at a minimum recommended level of 125 OTU/kg complete feed; and for turkeys for fattening, turkeys reared for breeding and weaned piglets at a proposed minimum level of 250 OTU/kg complete feed.
The authorisation under other provisions foresees:
In the directions for use of the additive and premixture, the storage temperature, storage life and stability to pelleting shall be indicated.
Recommended maximum dose for all authorised species is 500 OTU/kg of complete feedingstuff.
For use in feed rich in phytin‐bound phosphorus.
For safety: breathing protection, safety goggles, protective gloves shall be used during handling.
The applicant did not ask to modify these conditions of use.
The applicant requested the extension of use in feed for breeding hens, ornamental birds and minor pig species for fattening or breeding at a proposed minimum concentration of 125 OTU/kg complete feed; and in feed for turkeys for breeding purposes and suckling piglets for the period when solid feed is given at a proposed minimum concentration of 250 OTU/kg complete feed. The applicant asked to keep the same other provisions as in the current authorisation.
3.2. Safety
In a previous opinion, the FEEDAP Panel concluded that the additive is safe for the target species (chickens and turkeys for fattening, laying hens, chickens reared for laying, turkeys reared for breeding, other avian species for fattening and laying, weaned piglets, pigs for fattening and sows), consumers and the environment under the proposed conditions of use (EFSA FEEDAP Panel, 2011). Concerning user safety, the Panel concluded that the additive was not a skin or eye irritant or a skin sensitiser but should be considered a respiratory sensitiser.
The applicant stated that no adverse effects on target animals, consumer, user or the environment have been reported as part of its quality control system. 20
3.2.1. Extensive literature search
In the current application, the applicant conducted a literature search covering the period 2010–2021 considering studies in the target species (including those for which an extension of use has been requested in the current application), consumers, users/workers, the environment and the production strain. 21 The search was conducted in Web of Science, CAB Abstracts and FSTA, including a combination of search terms and synonyms regarding the product, production strain, consumer safety, user safety, environmental risk assessment, laboratory animals and target species (poultry and pigs). The number of hits identified after duplicates removal was 2,666. Titles and abstracts were further screened against the inclusion criteria concerning potentially harmful effects of phytases and the production microorganism on humans and/or laboratory and production animals, resulting in 26 hits. These publications were full text screened and four were considered for this assessment, one of them being an EFSA opinion on the same additive (EFSA FEEDAP Panel, 2011). The other three publications assessed were relevant for the safety of the additive in target species. No relevant publications were found regarding the safety for consumers, users or the environment.
3.2.2. Safety of the production microorganism
The recipient strain from which the production organism was derived belongs to K. phaffii, which is considered by EFSA to be suitable for the QPS approach to safety assessment when used for enzyme production (EFSA, 2007; EFSA BIOHAZ Panel, 2021). The production strain was unequivocally identified as K. phaffii ■■■■■ The other introduced genes raise no safety concerns. OptiPhos® is free from viable cells of the production organism and its recombinant DNA. Therefore, the data newly provided allow to confirm that the product remains safe as regards to the production strain.
3.2.3. Safety for the target species
Based on the tolerance studies previously assessed by the FEEDAP Panel, the additive was considered safe for chickens for fattening, turkeys for fattening and laying hens up to a 100‐fold overdose of the maximum recommended level of the enzyme (500 OTU/kg feed), and this conclusion was extended to chickens reared for laying, turkeys reared for breeding, other avian species for fattening or laying under the same conditions of use (EFSA FEEDAP Panel, 2011).
The literature search performed identified three publications relevant for the safety for the target species. Two of them included studies in laying hens (Meyer and Parsons, 2011) and in lactating sows (Jongbloed et al., 2013), using overdoses of OptiPhos® up to 15,000 and 1,000 OTU/kg feed, respectively. None of these studies showed adverse effects on the productive performance or health status of the animals under experiment. However, one published study in laying hens (Skřivan et al., 2017) mentioned a negative effect on laying performance when overdosing (1,500 FTU/kg feed) OptiPhos® to diets with a content of available phosphorus (avP) between 0.10% and 0.15% and a calcium concentration of 3.5%. No adverse effects were observed at other concentrations of avP and calcium tested in the same study. Therefore, the Panel considers that the effects seen were due to the balance avP:Ca in the diet of laying hens rather than the additive.
Overall, the new information provided supports that the additive remains safe under the approved conditions for the target species for which an authorisation exists.
The applicant requested the extension of use of the additive to several target species. The FEEDAP Panel considers that the conclusion reached in the previous opinion in chickens for fattening can be extrapolated to ornamental birds. Based on the conclusions reached in laying hens on the tolerance trial at 50,000 OTU/kg, the FEEDAP Panel considers that the conclusion can be extended to breeding hens provided that the same maximum level applies. Based on the tolerance studies previously assessed by EFSA, the additive was considered safe for weaned piglets, pigs for fattening and sows up to a 100‐fold overdose of the maximum recommended dose of the enzyme (500 OTU/kg feed) (EFSA FEEDAP Panel, 2011). The FEEDAP Panel considers that this conclusion can be extrapolated to all pig species and categories when used at the proposed conditions of use.
3.2.4. Conclusions on safety
Based on the information provided by the applicant and the fact that the manufacturing and composition of the additive have not been modified, the FEEDAP Panel considers that there is no evidence to reconsider the conclusions reached in the previous opinion. Therefore, the Panel concludes that the additive remains safe under the approved conditions for consumers and the environment, and that it should be considered a respiratory sensitiser.
With regard to the target species, the Panel concludes that the additive remains safe for use in chickens and turkeys for fattening, laying hens, chickens reared for laying, turkeys reared for breeding, other avian species for fattening and laying, weaned piglets, pigs for fattening and sows at the authorised conditions of use. The Panel also concludes that the additive is safe for breeding hens, turkeys for breeding purposes, ornamental birds, suckling piglets for the period in which solid feed is given and minor pig species for fattening or breeding, at the maximum recommended level (500 OTU/kg complete feed).
3.3. Efficacy
The efficacy of OptiPhos® (6‐phytase) was previously established at 125 OTU/kg in chickens for fattening and in laying hens, and by extension to other minor avian species for fattening and reared for laying; and at 250 OTU/kg for turkeys for fattening and by extension to turkeys reared for breeding. Likewise, the efficacy of the additive was established at 250 OTU/kg in weaned piglets and at 125 OTU/kg in pigs for fattening and sows (EFSA FEEDAP Panel, 2011, 2015).
The proposed conditions of use for these target species have not been modified and, therefore, no further assessment is needed for the renewal of the authorisation in these species.
The applicant requested the extension of use of the additive to several target species. The mode of action of the enzyme in the additive is well known and the effects can be reasonably considered similar between avian species. Therefore, the conclusions reached in chickens for fattening can be extrapolated to ornamental birds, and the conclusions reached in laying hens can be extended to breeding hens and extrapolated to other poultry species kept for egg production or breeding. Likewise, the conclusions reached in weaned piglets can be extended to suckling piglets for the period when solid feed is given; the ones in pigs for fattening extrapolated to other growing Suidae, and the ones in sows extrapolated to other reproductive Suidae.
3.3.1. Conclusions on efficacy
There is no need for the assessment of efficacy for chickens and turkeys for fattening, laying hens, chickens reared for laying, turkeys reared for breeding, other avian species for fattening and laying, weaned piglets, pigs for fattening and sows.
The additive has the potential to be efficacious in breeding hens, turkeys for breeding purposes, ornamental birds and minor pig species for fattening or breeding when added to feed at 125 OTU/kg; and in suckling piglets for the period in which solid feed is given at 250 OTU/kg feed.
3.4. Post‐market monitoring
The FEEDAP Panel considers that there is no need for specific requirements for a post‐market monitoring plan other than those established in the Feed Hygiene Regulation 22 and Good Manufacturing Practice.
4. Conclusions
The applicant provided evidence that the additive currently in the market complies with the conditions of the authorisation.
The Panel concludes that the additive remains safe for use in chickens for fattening, chickens reared for laying, laying hens, other avian species other than turkeys for fattening, pigs for fattening and sows at a maximum level of 500 OTU/kg of complete feed. The Panel also concludes that the additive is safe for breeding hens, turkeys for breeding purposes, ornamental birds, suckling piglets and minor pig species for fattening or breeding at the same maximum recommended level.
The use of the feed additive in animal nutrition remains safe under the approved conditions for consumers and the environment. The additive is not a skin or eye irritant or a skin sensitiser, but it should be considered a respiratory sensitiser.
There is no need for the assessment of efficacy for chickens and turkeys for fattening, laying hens, chickens reared for laying, turkeys reared for breeding, other avian species for fattening and laying, weaned piglets, pigs for fattening and sows. The additive has the potential to be efficacious in breeding hens, turkeys for breeding purposes, ornamental birds and minor pig species for fattening or breeding when added to feed at 125 OTU/kg; and in suckling piglets for the period in which solid feed is given at 250 OTU/kg feed.
5. Documentation provided to EFSA/Chronology
| Date | Event |
|---|---|
| 09/03/2021 | Reception mandate from the European Commission |
| 17/03/2021 | Dossier received by EFSA. FAD‐2021‐0004 OptiPhos (6‐phytase) for chickens for fattening, chickens reared for laying, laying hens, turkeys for fattening, turkeys reared for breeding, other avian species other than turkeys for fattening and turkeys reared for breeding, pigs for fattening, sows, piglets (weaned), breeding hens, ornamental birds, turkeys for breeding purposes, minor pig species for fattening or breeding and piglets (suckling). Submitted by Huvepharma EOOd |
| 23/04/2021 | Application validated by EFSA – Start of the scientific assessment |
| 26/07/2021 | Comments received from Member States |
| 26/07/2021 | Request of supplementary information to the applicant in line with Article 8(1)(2) of Regulation (EC) No 1831/2003 – Scientific assessment suspended. Issues: characterisation/safety for the user/efficacy |
| 30/12/2021 | Reception of supplementary information from the applicant ‐ Scientific assessment re‐started |
| 03/02/2022 | Request of supplementary information to the applicant in line with Article 8(1)(2) of Regulation (EC) No 1831/2003 – Scientific assessment suspended. Issues: Purity |
| 18/02/2022 | Reception of supplementary information from the applicant ‐ Scientific assessment re‐started |
| 23/03/2022 | Opinion adopted by the FEEDAP Panel. End of the Scientific assessment |
Abbreviations
- ADFI
average daily feed intake
- ADG
average daily gain
- ADI
average daily intake
- BW
body weight
- CAS
Chemical Abstracts Service
- CD
Commission Decision
- CFU
colony‐forming unit
- CV
coefficient of variation
- DM
dry matter
- EINECS
European Inventory of Existing Chemical Substances
- EURL
European Union Reference Laboratory
- FAO
Food Agricultural Organization
- FCR
feed conversion ratio
- FEEDAP
EFSA Scientific Panel on Additives and Products or Substances used in Animal Feed
- HACCP
hazard analysis and critical control points
- IUPAC
International Union of Pure and Applied Chemistry
- JECFA
The Joint FAO/WHO Expert Committee on Food Additives
- LOD
limit of detection
- LOQ
limit of quantification
- MIC
minimum inhibitory concentration
- MW
molecular weight
- NOAEL
no observed adverse effect level
- OECD
Organisation for Economic Co‐operation and Development
- RH
relative humidity
- SCAN
Scientific Committee on Animal Nutrition
- SCF
Scientific Committee on Food
- SNPs
Single-nucleotide polymorphisms
- WHO
World Health Organization
Suggested citation: EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed) , Bampidis V, Azimonti G, Bastos ML, Christensen H, Dusemund B, Fašmon Durjava M, Kouba M, López‐Alonso M, López Puente S, Marcon F, Mayo B, Pechová A, Petkova M, Ramos F, Sanz Y, Villa RE, Woutersen R, Galobart J, Anguita M and Ortuño J, 2022. Scientific Opinion on the safety and efficacy of a feed additive consisting of 6‐phytase (produced by Komagataella phaffii DSM 23036) (OptiPhos®) for poultry for fattening, chickens reared for laying, laying hens, turkeys reared for breeding, weaned piglets, pigs for fattening and sows for the renewal of their authorisation and for the new use in breeding hens and turkeys, ornamental birds, suckling piglets and minor pig species for fattening and breeding (Huvepharma EOOd). EFSA Journal 2022;20(5):7238, 11 pp. 10.2903/j.efsa.2022.7238
Requestor: European Commission
Question number: EFSA‐Q‐2021‐00152
Panel members: Vasileios Bampidis, Giovanna Azimonti, Maria de Lourdes Bastos, Henrik Christensen, Birgit Dusemund, Mojca Fašmon Durjava, Maryline Kouba, Marta López‐Alonso, Secundino López Puente, Francesca Marcon, Baltasar Mayo, Alena Pechová, Mariana Petkova, Fernando Ramos, Yolanda Sanz, Roberto Edoardo Villa and Ruud Woutersen.
Legal notice: Relevant information or parts of this scientific output have been blackened in accordance with the confidentiality requests formulated by the applicant pending a decision thereon by the European Commission. The full output has been shared with the European Commission, EU Member States and the applicant. The blackening will be subject to review once the decision on the confidentiality requests is adopted by the European Commission.
Declarations of interest: The declarations of interest of all scientific experts active in EFSA’s work are available at https://ess.efsa.europa.eu/doi/doiweb/doisearch.
Acknowledgments: The Panel wishes to thank the following for the support provided to this scientific output (in alphabetical order of the last name): WG on Animal Nutrition and WG on Microbiology.
Adopted: 23 March 2022
Notes
Regulation (EC) No 1831/2003 of the European Parliament and of the council of 22 September 2003 on the additives for use in animal nutrition. OJ L 268, 18.10.2003, p. 29.
Huvepharma EOOd, 3a Nikolay Haytov Str, 1113, Sofia (Bulgaria).
Commission Implementing Regulation (EU) No 98/2012 of 7 February 2012, OJ L 35, 08.02.2012 p. 6 / Corrigendum PL in OJ L 120, 05.05.2012. p. 16 / Amended by Commission Implementing Regulation (EU) 2016/348 of 10 March 2016; Commission Implementing Regulation (EU) 2017/2274 of 8 December 2017, OJ L 326 09.12.2017 p. 44.
FEED dossier reference: FAD‐2021‐0004.
The full report is available on the EU Science Hub website: https://joint-research-centre.ec.europa.eu/system/files/2016-11/finirep_fad-2016-0019_optiphos.pdf
Commission Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives. OJ L 133, 22.5.2008, p. 1.
one OTU is the amount of enzyme that catalyses the release of one micromole of inorganic phosphate per minute from 5.1 mM sodium phytate in pH 5.5 citrate buffer at 37°C, measured as the blue phosphorus–molybdate complex colour at 820 nm.
Technical dossier/Section II/Annexes 03, 04 and 05 and SIn_301221/Annexes RTQ 20, 21 and 22.
Technical dossier/Section II/Annex 08 and SIn_301221/Annex RTQ_02.
LOQ; Arsenic: 0.04 mg/kg; Lead: 0.05 mg/kg; Mercury: 0.005 mg/kg; Cadmium: 0.01 mg/kg; Aflatoxins (B1/B2/G1/G2): 1 µg/kg; Ochratoxin A: 1 µg/kg; Zearalenone: 5 µg/kg; Fumonisins (B1+B2): 40 µg/kg; Deoxynivalenol: 100 µg/kg.
Technical dossier/Section II/Annex 08.
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Technical dossier/SIn_301221/Annex RTQ_03.
Technical dossier/SIn_301221/Annex RTQ_07.
Technical dossier/SIn_301221/Annex RTQ_08.
Technical dossier/SIn_301221/Annex RTQ_05.
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Technical dossier/SIn_301221/Annex RTQ_17.
Technical dossier/SIn_301221/Annex RTQ_09.
Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene. OJ L 35, 8.2.2005, p. 1.
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