title: Commission Implementing Regulation (EU) 2020/375 of 2 March 2020 approving amendments to the specification for a Protected Designation of Origin or a Protected Geographical Indication ‘Priorat/Priorato’ (PDO)

text:
                  6.3.2020

                  EN

                  Official Journal of the European Union

                  L 69/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/375
         of 2 March 2020
         approving amendments to the specification for a Protected Designation of Origin or a Protected Geographical Indication ‘Priorat/Priorato’ (PDO)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (1), and in particular Article 99 thereof,
         Whereas:

                     (1)

                     The Commission has examined the application for the approval of amendments to the specification for the Protected Designation of Origin ‘Priorat/Priorato’, sent by Spain in accordance with Article 105 of Regulation (EU) No 1308/2013.

                     (2)

                     The Commission has published the application for the approval of the amendments to the specification in the Official Journal of the European Union, as required by Article 97(3) of Regulation (EU) No 1308/2013 (2).

                     (3)

                     No statement of objection has been received by the Commission under Article 98 of Regulation (EU) No 1308/2013.

                     (4)

                     The amendments to the specification should therefore be approved in accordance with Article 99 of Regulation (EU) No 1308/2013.

                     (5)

                     The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Common Organisation of the Agricultural Markets,

               HAS ADOPTED THIS REGULATION:

            Article 1
            The amendments to the specification published in the Official Journal of the European Union regarding the name ‘Priorat/Priorato’ (PDO) are hereby approved.

            Article 2
            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, 2 March 2020.

                  For the Commission,

                  On behalf of the President,

               Janusz WOJCIECHOWSKI

                  Member of the Commission

            (1)  OJ L 347, 20.12.2013, p. 671.

            (2)  OJ C 316, 20.9.2019, p. 10.


title: Commission Implementing Regulation (EU) 2020/376 of 5 March 2020 concerning the authorisation of Norbixin (annatto F) as a feed additive for cats and dogs (Text with EEA relevance)

text:
                  6.3.2020

                  EN

                  Official Journal of the European Union

                  L 69/3

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/376
         of 5 March 2020
         concerning the authorisation of Norbixin (annatto F) as a feed additive for cats and dogs
         (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:

                     (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(2) of Regulation (EC) No 1831/2003 provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

                     (2)

                     Norbixin (annatto F) was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for dogs and cats belonging to the group ‘colourants, including pigments’, under the heading ‘colouring agents authorised for colouring foodstuffs by Community rules other than Patent blue V, Acid brilliant green BS, and Canthaxanthin’. This colourant was not specifically authorised but entered in this generic entry. The additive was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1)(b) 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 Norbixin (annatto F) as a feed additive for dogs and cats. The applicant requested the additive to be classified in the additive category ‘sensory additives’ and in the functional group ‘colourants’. The 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 22 March 2017 (3) that, under the proposed conditions of use, Norbixin (annatto F) does not have an adverse effect on animal health. It also concluded that the substance is a strong alkaline solution that makes it corrosive and therefore harmful for the user. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. In accordance with Commission Regulation (EC) No 429/2008 (4), phase I of the environmental risk assessment has determined that Norbixin (annatto F), as an additive intended for non-food producing animals, is exempted from further assessment due to the unlikelihood of a significant environmental effect, there being no scientifically-based evidence for concern having been identified by the Authority in its above-mentioned opinion. The Authority further concluded that the additive concerned is effective in adding colour to feedingstuffs. 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 additive in feed submitted by the European Union Reference Laboratory set up by Regulation (EC) No 1831/2003. The report of the European Union Reference Laboratory for Feed Additives (EURL-FA) showed that the applicant did not submit any experimental data for the quantification of Norbixin (annatto F) in feedingstuffs. The applicant was requested to provide such data and the method was validated and included in an addendum of the EURL-FA report.

                     (5)

                     The assessment of Norbixin (annatto F) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that additive should be authorised as specified in the Annex to this Regulation.

                     (6)

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

                     (7)

                     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 ‘colourants’, is authorised as an 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 that substance, which are produced and labelled before 26 September 2020 in accordance with the rules applicable before 26 March 2020 may continue to be placed on the market and used until the existing stocks are exhausted.

               2.   Feed materials and compound feed containing the substance specified in the Annex which are produced and labelled before 26 March 2022 in accordance with the rules applicable before 26 March 2020 may continue to be placed on the market and used until the existing stocks are exhausted.

            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, 5 March 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (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 2017; 15(4):4764.

            (4)  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).

            ANNEX

                           Identification number of the additive

                           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: Colourants. (i) substances that add or restore colour in feedingstuffs

                        2a160b

                        Norbixin (annatto F)

                           Additive composition:

                        Liquid preparation of annatto F containing 2,3-2,7 % norbixin potassium salt

                           Characterisation of the active substance:

                        Alkali processed norbixin,acid precipitated (annatto F) is described as the potassium salt of norbixin (dipotassium 6,6’-diapo-psi,psi-carotenedioate);
                        It is a carotenoid derivative prepared by removal of the outer coating of the seeds of the annatto tree (Bixa orellana L) and further chemical processing.
                        Solid form
                        Chemical formula: C24H26K2O4
                        CAS number 33261-80-2

                           Analytical method
                            (1)

                        For the quantification of norbixin potassium in the feed additive:

                                    —

                                    Spectrophotometry at 482 nm (JECFA monograph on Annatto extracts (alkali processed norbixin, acid-precipitated)

                              For the quantification of norbixin potassium in feedingstuffs:

                                    —

                                    Reversed phase high performance liquid chromatography coupled to diode array detection (RP-HPLC-DAD)

                        Cats
                        Dogs

                        -

                        -

                        13
                        16

                                    1.

                                    In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.

                                    2.

                                    For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. 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 eye and skin protection.

                        26.3.2030

               (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


title: Commission Implementing Regulation (EU) 2020/377 of 5 March 2020 concerning the authorisation of sodium selenate as a feed additive for ruminants (Text with EEA relevance)

text:
                  6.3.2020

                  EN

                  Official Journal of the European Union

                  L 69/6

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/377
         of 5 March 2020
         concerning the authorisation of sodium selenate as a feed additive for ruminants
         (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:

                     (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.

                     (2)

                     In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of sodium selenate as a feed additive for ruminants.

                     (3)

                     The applicant requested sodium selenate to be classified in the additive category ‘nutritional additives’. The 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 3 July 2019 (2) that, under the proposed conditions of use, sodium selenate does not have adverse effects on animal health, consumer safety or the environment. It also concluded that the additive is considered a skin and eye irritant and a skin and respiratory sensitiser. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. The Authority also concluded that the additive is an efficacious source of selenium for ruminants. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the reports on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Article 21 of Regulation (EC) No 1831/2003.

                     (5)

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

                     (6)

                     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
            The substance specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘compounds of trace elements’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

            Article 2
            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, 5 March 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

            (2)  EFSA Journal 2019;17(7):5788.

            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

                        Selenium in mg/kg of complete feed with a moisture content of 12 %

                           Category of nutritional additives. Functional group: compounds of trace elements

                        3b803

                        Sodium selenate

                           Characterisation of the additive

                        Sodium selenate, as a powder, with a minimum content of 41 % selenium

                           Characterisation of the active substance

                        Disodium selenate
                        Chemical formula: Na2SeO4

                        CAS number 13410-01-0

                           Analytical method
                            (1)

                        For the quantification of total selenium in the feed additive:

                                    —

                                    Titration

                              For the quantification of total sodium in sodium selenate:

                                    —

                                    Atomic Absorption Spectrometry (AAS) – EN ISO 6869:2000; or

                                    —

                                    Inductively Coupled Plasma Atomic Emission Spectrometry (ICP-AES) – EN 15510:2007

                              For the quantification of total selenium in premixtures, feed materials and compound feed:

                                    —

                                    Hydride Generation Atomic Absorption Spectrometry (HGAAS) after microwave digestion – EN 16159:2012

                        Ruminants

                        —

                        0,50 (total)

                                    1.

                                    Sodium selenate may be placed on the market and used as an additive consisting of a preparation.

                                    2.

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

                                    3.

                                    For users of the additive and premixture, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eye contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixture shall be used with appropriate personal protective equipment.

                        26 March 2030

               (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


title: Commission Implementing Regulation (EU) 2020/378 of 5 March 2020 concerning the authorisation of L-leucine as a feed additive for all animal species (Text with EEA relevance)

text:
                  6.3.2020

                  EN

                  Official Journal of the European Union

                  L 69/9

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/378
         of 5 March 2020
         concerning the authorisation of L-leucine 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:

                     (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.

                     (2)

                     In accordance with Article 7(1) of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of L-leucine produced by Escherichia coli NITE BP-02351 as a nutritional feed additive for use in feed and in water for drinking and as sensory feed additive for use in feed for all animal species. This application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

                     (3)

                     This application concerns the authorisation of L-leucine produced by Escherichia coli NITE BP-02351 as a feed additive for all animal species to be classified in the additive category ‘nutritional additives’ (functional group ‘amino acids, their salts and analogues’) and in the additive category ‘sensory additives’ (functional group ‘flavouring compounds’).

                     (4)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 2 April 2019 (2) that, under the proposed conditions of use, L-leucine produced by Escherichia coli NITE BP-02351 does not have an adverse effect on animal health, consumer health or the environment. It also stated that L-leucine produced by Escherichia coli NITE BP-02351 could pose an inhalation risk for the users of the additive. Therefore, appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive.

                     (5)

                     The Authority concluded that it is an effective source of the amino acid L-leucine for all animal species. For the supplemental L-leucine to be fully efficacious in ruminants, it should be protected against degradation in the rumen. The Authority expressed in a previous statement a concern over potential nutritional imbalances for amino acids, when they are administered via water for drinking. However, the Authority did not propose a maximum content for L-leucine. Thus, it is appropriate to indicate on the label of the additive, and premixtures containing it, an alert to take into account the dietary supply with all the essential and conditionally essential amino acids, particularly in the case of supplementation with L-leucine as amino acid via water for drinking.

                     (6)

                     As regards the use of L-leucine as a flavouring, the Authority states that no further demonstration of efficacy is necessary when the substance is used at the recommended dose level. The use of L-leucine as a flavouring compound is not authorised in water for drinking. At the recommended dose, L-leucine as flavouring compound is not likely to pose any concern for the dietary supply with all the essential and conditionally essential amino acids.

                     (7)

                     The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the reports on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

                     (8)

                     The assessment of L-leucine shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this additive should be authorised as specified in the Annex to this Regulation.

                     (9)

                     The fact that the use of the L-leucine is not authorised for use as a flavouring in water for drinking, does not preclude its use in compound feed, which is administered via water.

                     (10)

                     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
            L-leucine produced by Escherichia coli NITE BP-02351, specified in the Annex, is authorised as a feed additive in animal nutrition in the additive category ‘nutritional additives’, functional group ‘amino acids, their salts and analogues’, and in the additive category ‘sensory additives’, functional group ‘flavouring compounds’, subject to the conditions laid down in that Annex.

            Article 2
            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, 5 March 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

            (2)  EFSA Journal 2019;17(5):5689.

            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/kg of complete feed with a moisture content of 12 %

                           Category of nutritional additives. Functional group: amino acids, their salts and analogues.

                        3c382

                        -

                        L-leucine

                           Additive composition:

                        Powder with a minimum content of L-leucine of 98 % (on a dry matter basis) and a maximum content of 1,5 % water

                        All animal species

                                    1.

                                    L-leucine may be placed on the market and used as an additive consisting of a preparation.

                                    2.

                                    The additive can be also used via water for drinking.

                                    3.

                                    In the directions for use of the additive and premixture, the storage conditions, the stability to heat treatment and the stability in water for drinking shall be indicated.

                                    4.

                                    For users of the additive and premixture, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixture shall be used with personal protective equipment, including breathing protection.

                                    5.

                                    The endotoxin content of the additive and its dusting potential shall ensure a maximal endotoxin exposure of 1600 IU endotoxins/m3 air (2).

                                    6.

                                    Declaration to be made: ‘The supplementation with L-leucine, in particular via water for drinking, should take into account all essential and conditional essential amino acids in order to avoid imbalances’.

                        26.3.2030

                           Characterisation of the active substance:

                        L-leucine produced by fermentation with Escherichia coli NITE BP-02351.
                        Chemical formula: C6H13NO2
                        CAS number: 61-90-5

                           Analytical method
                            (1):
                        For the identification of L-leucine in the feed additive:

                                    —

                                    Food Chemical Codex ‘L-leucine monohydrochloride monograph’

                              For the quantification of leucine in the feed additive:

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD)

                              For the quantification of leucine in premixtures:

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) or

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS) – Commission Regulation (EC) No 152/2009

                              For the quantification of leucine in compound feed and feed materials:

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS) – Commission Regulation (EC) No 152/2009

                              For the quantification of leucine in water:

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS)

                           Category: Sensory additives. Functional group: Flavouring compounds

                        3c382

                        -

                        L-leucine

                           Additive composition:

                        Powder with a minimum content of L-leucine of 98 % (on a dry matter basis) and a maximum content of 1,5 % water

                        All animal species

                        -

                        -

                        -

                                    1.

                                    L-leucine may be placed on the market and used as an additive consisting of a preparation.

                                    2.

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

                                    3.

                                    In the directions for use of the additive and premixture, the storage conditions and the stability to heat treatment shall be indicated.

                                    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 %: 25 mg/kg.’

                                    5.

                                    The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 25 mg/kg.

                                    6.

                                    For users of the additive and premixture, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixture shall be used with personal protective equipment, including breathing protection.

                                    7.

                                    The endotoxin content of the additive and its dusting potential shall ensure a maximal endotoxin exposure of 1600 IU endotoxins/m3 air (2).

                        26.3.2030

                           Characterisation of the active substance:

                        L-leucine produced by fermentation with Escherichia coli NITE BP-02351
                        Chemical formula: C6H13NO2
                        CAS number: 61-90-5
                        FLAVIS No 17.012

                           Method of analysis
                            (1):
                        For the identification of L-leucine in the feed additive:

                                    —

                                    Food Chemical Codex ‘L-leucine monohydrochloride monograph’

                              For the quantification of leucine in the feed additive:

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD)

                              For the quantification of leucine in premixtures:

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) or

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS) – Commission Regulation (EC) No 152/2009

               (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

               (2)  Exposure calculated based on the endotoxin level and the dusting potential of the additive according to the method used by EFSA (EFSA Journal 2019;17(5):5689); analytical method: European Pharmacopoeia 2.6.14 (bacterial endotoxins).