title: Commission Implementing Regulation (EU) 2021/365 of 26 February 2021 approving active chlorine released from hypochlorous acid as an active substance for use in biocidal products of product-type 1 (Text with EEA relevance)

text:
                  1.3.2021

                  EN

                  Official Journal of the European Union

                  L 70/9

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/365
         of 26 February 2021
         approving active chlorine released from hypochlorous acid as an active substance for use in biocidal products of product-type 1
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 9(1)(a) thereof,
         Whereas:

                     (1)

                     On 31 July 2007, the competent authority of Slovakia (‘the evaluating competent authority’) received an application, in accordance with Article 11(1) of Directive 98/8/EC of the European Parliament and of the Council (2), for the inclusion of the active substance active chlorine released from hypochlorous acid in Annex I to that Directive for use in biocidal products of product-type 1, human hygiene, as defined in Annex V to that Directive, which corresponds to product-type 1 as defined in Annex V to Regulation (EU) No 528/2012.

                     (2)

                     On 19 November 2010, the evaluating competent authority submitted the assessment report together with its conclusions to the Commission in accordance with Article 11(2) of Directive 98/8/EC.

                     (3)

                     On 16 June 2020, the Biocidal Products Committee adopted the opinion of the European Chemicals Agency (3) (‘the Agency’), having regard to the conclusions of the evaluating competent authority.

                     (4)

                     According to that opinion, biocidal products of product-type 1 using active chlorine released from hypochlorous acid may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC, provided that certain specifications and conditions concerning their use are complied with.

                     (5)

                     Taking into account the opinion of the Agency, it is appropriate to approve active chlorine released from hypochlorous acid as an active substance for use in biocidal products of product-type 1 subject to compliance with certain specifications and conditions.

                     (6)

                     The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Active chlorine released from hypochlorous acid is approved as an active substance for use in biocidal products of product-type 1 subject to the specifications and conditions set out in the 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, 26 February 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 167, 27.6.2012, p. 1.

            (2)  Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1).

            (3)  Biocidal Products Committee Opinion on the application for approval of the active substance active chlorine released from hypochlorous acid, Product type:1, ECHA/BPC/255 adopted on 16 June 2020.

            ANNEX

                        Common Name

                        IUPAC Name
                        Identification Numbers

                        Minimum degree of purity of the active substance (1)

                        Date of approval

                        Expiry date of approval

                        Product type

                        Specific conditions

                        Active chlorine released from hypochlorous acid

                        IUPAC name: Hypochlorous acid
                        EC No: 232-232-5
                        CAS No: 7790-92-3

                        Specification established for hypochlorous acid (as dry weight min. 90,87 % w/w) releasing active chlorine.
                        Hypochlorous acid is the predominant species at pH 3,0 – 7,4.

                        1 July 2021

                        30 June 2031

                        1

                        The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active substance.

               (1)  The purity indicated in this column was the minimum degree of purity of the active substance evaluated. The active substance in the product placed on the market can be of equal or different purity if it has been proven to be technically equivalent to the evaluated active substance.


title: Commission Implementing Regulation (EU) 2021/367 of 1 March 2021 concerning the renewal of the authorisation of a preparation of Saccharomyces cerevisiae CNCM I-4407 as a feed additive for calves for rearing and repealing Regulation (EU) No 883/2010 (holder of authorisation S.I. Lesaffre) (Text with EEA relevance)

text:
                  2.3.2021

                  EN

                  Official Journal of the European Union

                  L 71/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/367
         of 1 March 2021
         concerning the renewal of the authorisation of a preparation of Saccharomyces cerevisiae CNCM I-4407 as a feed additive for calves for rearing and repealing Regulation (EU) No 883/2010 (holder of authorisation S.I. Lesaffre)
         (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 and renewing such authorisation.

                     (2)

                        Saccharomyces cerevisiae CNCM I-4407, previously identified as Saccharomyces cerevisiae NCYC Sc47, was authorised for 10 years as a feed additive for calves for rearing by Commission Regulation (EU) No 883/2010 (2).

                     (3)

                     In accordance with Article 14 of Regulation (EC) No 1831/2003, an application was submitted by the holder of the authorisation of Saccharomyces cerevisiae CNCM I-4407 as a feed additive for the renewal of the authorisation for calves for rearing, requesting the additive to be classified in the additive category ‘zootechnical additives’. That application was accompanied by the particulars and documents required under Article 14(2) of that Regulation.

                     (4)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 25 May 2020 (3) that the applicant has provided evidence that the additive complies with the existing conditions of authorisation. The Authority concluded that the preparation of Saccharomyces cerevisiae CNCM I-4407 does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that it is not a skin or eye irritant and, in the absence of data, no conclusions can be drawn on the dermal sensitisation potential of the additive. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards to users of the additive. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

                     (5)

                     The assessment of a preparation of Saccharomyces cerevisiae CNCM I-4407 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the authorisation of that additive should be renewed.

                     (6)

                     As a consequence of the renewal of the authorisation of a preparation of Saccharomyces cerevisiae CNCM I-4407 as a feed additive, Regulation (EU) No 883/2010 should be repealed.

                     (7)

                     Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the preparation of Saccharomyces cerevisiae CNCM I-4407, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the renewal of the authorisation.

                     (8)

                     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
            Renewal of the authorisation
            The authorisation of the additive specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’, is renewed subject to the conditions laid down in that Annex.

            Article 2
            Transitional period

               1.   The additive specified in the Annex and premixtures containing it, which are produced and labelled before 22 September 2021 in accordance with the rules applicable before 22 March 2021 may continue to be placed on the market and used until the existing stocks are exhausted.

               2.   Compound feed and feed materials containing the additive specified in the Annex which are produced and labelled before 22 March 2022 in accordance with the rules applicable before 22 March 2021 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.

            Article 3
            Repeal
            Regulation (EU) No 883/2010 is repealed.

            Article 4
            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, 1 March 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

            (2)  Commission Regulation (EU) No 883/2010 of 7 October 2010 concerning the authorisation of a new use of Saccharomyces cerevisiae NCYC Sc 47 as a feed additive for calves for rearing (holder of the authorisation Société Industrielle Lesaffre) (OJ L 265, 8.10.2010, p. 1).

            (3)  EFSA Journal 2020;18(6):6167.

            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

                        CFU/kg of complete feedingstuff with a moisture content of 12 %

                           Category of zootechnical additives. Functional group: gut flora stabilisers

                        4b1702

                        S.I. Lesaffre

                           Saccharomyces cerevisiae CNCM I-4407

                           Additive composition

                        Preparation of Saccharomyces cerevisiae CNCM I-4407 containing a minimum of 5 × 109 CFU/g
                        Solid form

                        Calves for rearing

                        -

                        1,5 × 109

                        -

                                    1.

                                    In the directions for use of the additive and premixtures, 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.

                        22.3.2031

                           Characterisation of the active substance

                        Viable dried cells of Saccharomyces cerevisiae CNCM I-4407

                           Analytical method
                            (1)

                        Enumeration: pour plate method
                        using chloramphenicol dextrose
                        yeast extract agar EN 15789
                        Identification: polymerase chain reaction (PCR) method CEN/TS
                        15790.

               (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) 2021/368 of 1 March 2021 granting a Union authorisation for the single biocidal product ‘Aero-Sense Aircraft Insecticide ASD’ (Text with EEA relevance)

text:
                  2.3.2021

                  EN

                  Official Journal of the European Union

                  L 71/4

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/368
         of 1 March 2021
         granting a Union authorisation for the single biocidal product ‘Aero-Sense Aircraft Insecticide ASD’
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular the first subparagraph of Article 44(5) thereof,
         Whereas:

                     (1)

                     On 2 February 2018, Aero-Sense NV submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a single biocidal product named ‘Aero-Sense Aircraft Insecticide ASD’ of product-type 18, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Belgium had agreed to evaluate the application. The application was recorded under case number BC-DX037393-17 in the Register for Biocidal Products.

                     (2)

                     ‘Aero-Sense Aircraft Insecticide ASD’ contains 1R-trans phenothrin, as the active substance, which is included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012.

                     (3)

                     On 7 May 2020, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the European Chemicals Agency (‘the Agency’).

                     (4)

                     On 2 July 2020, the Agency submitted to the Commission an opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘Aero-Sense Aircraft Insecticide ASD’ and the final assessment report on the single biocidal product in accordance with Article 44(3) of Regulation (EU) No 528/2012.

                     (5)

                     The opinion concludes that ‘Aero-Sense Aircraft Insecticide ASD’ is a biocidal product, that it is eligible for Union authorisation in accordance with Article 42(1) of Regulation (EU) No 528/2012 and that subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) of that Regulation.

                     (6)

                     On 4 August 2020, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.

                     (7)

                     The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘Aero-Sense Aircraft Insecticide ASD’.

                     (8)

                     The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

               HAS ADOPTED THIS REGULATION:

            Article 1
            A Union authorisation with authorisation number EU-0024297-0000 is granted to Aero-Sense NV for the making available on the market and use of the single biocidal product ‘Aero-Sense Aircraft Insecticide ASD’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
            The Union authorisation is valid from 22 March 2021 until 28 February 2031.

            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, 1 March 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 167, 27.6.2012, p. 1.

            (2)  ECHA opinion of 17 June 2020 on the Union authorisation of the biocidal product ‘Aero-Sense Aircraft Insecticide ASD’ (ECHA/BPC/262/2020), https://echa.europa.eu/bpc-opinions-on-union-authorisation

            ANNEX
            Summary of product characteristics for a biocidal product
            Aero-Sense Aircraft Insecticide ASD
            Product type 18 – Insecticides, acaricides and products to control other arthropods (Pest control)
            Authorisation number: EU-0024297-0000
            R4BP asset number: EU-0024297-0000
            1.   ADMINISTRATIVE INFORMATION

            1.1.   Trade name(s) of the product

                        Trade name(s)

                        Aero-Sense Aircraft Insecticide ASD

                  1.2.   Authorisation holder

                        Name and address of the authorisation holder

                        Name

                        Aero-Sense NV

                        Address

                        Schaapbruggestraat 50, 8800 Roeselare, Belgium

                        Authorisation number

                        EU-0024297-0000

                           R4BP asset number

                        EU-0024297-0000

                        Date of the authorisation

                        22 March 2021

                        Expiry date of the authorisation

                        28 February 2031

                  1.3.   Manufacturer(s) of the product

                        Name of manufacturer

                        Volcke Aerosol Connection

                        Address of manufacturer

                        Industrielaan 15, 8520 Kuurne Belgium

                        Location of manufacturing sites

                        Industrielaan 15, 8520 Kuurne Belgium

                        Name of manufacturer

                        Envasado Xiomara, S.L.

                        Address of manufacturer

                        Polígono Industrial La Torrecilla Chica, 6, 45220 Yeles – Toledo Spain

                        Location of manufacturing sites

                        Polígono Industrial La Torrecilla Chica, 6, 45220 Yeles – Toledo Spain

                        Name of manufacturer

                        Aero-Sense NV

                        Address of manufacturer

                        Kachtemsestraat 289, 8800 Roeselare Belgium

                        Location of manufacturing sites

                        Kachtemsestraat 289, 8800 Roeselare Belgium

                  1.4.   Manufacturer(s) of the active substance(s)

                        Active substance

                        1R-trans phenothrin

                        Name of manufacturer

                        Endura S.p.A

                        Address of manufacturer

                        Viale Pietro Pietramellara 5, 40121 Bologna Italy

                        Location of manufacturing sites

                        39 Wenfeng Road, 225009 Yangzhou, Jiangsu China

                  2.   PRODUCT COMPOSITION AND FORMULATION

            2.1.   Qualitative and quantitative information on the composition of the product

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        1R-trans phenothrin

                        3-phenoxybenzyl (1R,3R)-2,2-dimethyl- 3-(2-methylprop-1- enyl)cyclopropanecarboxylate

                        Active Substance

                        26046-85-5

                        247-431-2

                        2,0

                  2.2.   Type of formulation

            AE – Aerosol dispenser
            3.   HAZARD AND PRECAUTIONARY STATEMENTS

                        Hazard statements

                        Pressurised container: May burst if heated
                        Very toxic to aquatic life.
                        Very toxic to aquatic life with long lasting effects.

                        Precautionary statements

                        Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
                        Do not pierce or burn, even after use.
                        Avoid release to the environment.
                        Collect spillage.
                        Protect from sunlight. Do not expose to temperatures exceeding 50 °C/122 °F.
                        Dispose of contents/container to hazardous or special waste collection point.

                  4.   AUTHORISED USE(S)

            4.1.   Use description

               Table 1. Use # 1 – Mosquitoes – Aircraft treatment – Professionals

                        Product type

                        PT18 – Insecticides, acaricides and products to control other arthropods (Pest control)

                        Where relevant, an exact description of the authorised use

                        Insecticide

                        Target organism(s) (including development stage)

                        Scientific name: Culex spp.
                        Common name: Culex mosquitoes
                        Development stage: Adults
                        Scientific name: Aedes spp.
                        Common name: Aedes mosquitoes
                        Development stage: Adults
                        Scientific name: Anopheles spp.
                        Common name: Anopheles mosquitoes
                        Development stage: Adults

                        Field(s) of use

                        Indoor
                        Application in cockpit and cabin for aircraft disinsection.

                        Application method(s)

                        Aerosol spray
                        Spraying

                        Application rate(s) and frequency

                        Recommended application rate: 35 g/100 m3 (i.e. 0,7 g a.i./100 m3).
                        Ready-to-use product.
                        Treatment should be repeated on each flight for which a disinsection treatment is required.
                        One application per flight only.

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

                        Aluminium (ALU) printed can 18 bar – Full colour printed
                        White cap (One Shot actuator) or Blue cap (Multi Shot actuator)
                        Packed in cardboard packaging per 24 pieces
                        Available in different can sizes:

                                    •

                                    40 g (34 mL)

                                    •

                                    60 g (52 mL)

                                    •

                                    100 g (86 mL)

                  4.1.1.   Use-specific instructions for use

                        —

                        Please refer to the onboard manual for the number of cans required for a disinsection treatment for each specific aircraft type.

                        —

                        The disinsection procedure should be announced to passengers prior to the application of the product in the aircraft. Passengers should be advised to close their eyes and cover their faces whilst the procedure is carried out.

                        —

                        Do not spray directly on skin or in eyes.

                        —

                        Do not spray on or near food, food preparation areas or food utensils.

                        —

                        Wash hands after handling.

                        —

                        Prevent use by unauthorised personnel.

                        —

                        Remove the cap.

                        —

                        Hold can(s) vertically at arm’s length.

                        —

                        ‘One shot’ white cap: depress tab on spray nozzle until it locks down. The aerosol product is released in one continuous spray.

                        —

                        ‘Multi shot’ blue cap: depress tab on spray nozzle until sufficient quantity is released or until product is completely discharged.

                        —

                        The insecticide aerosol should be sprayed by directing the nozzle of the aerosol dispenser at an angle of approximately 45° towards the ceiling throughout the aircraft.

                        —

                        The spray should be directed slightly behind the user.

                        —

                        Spray evenly throughout the whole area.

                        40 g (34 mL) – One can effectively treats 114 m3 of air volume;

                        60 g (52 mL) – One can effectively treats 171 m3 of air volume;

                        100 g (86 mL) – One can effectively treats 285 m3 of air volume.

               ‘Blocks away’ disinsection

            This procedure takes place prior to take off, after passengers have boarded and the doors have been closed.
            The flight deck is sprayed prior to boarding by the cabin crew.
            For disinsection to be effective, the aircraft air conditioning system must be switched off whilst spraying. The cabin crew must treat all possible insect harbourages including toilets, galleys and wardrobes, unless these areas have been sprayed together with the flight-deck prior to boarding.

               ‘Top-of-descent’ (in-flight spraying)

            According to WHO guidance: pre-flight and top-of-descent spraying is a two-part disinsection method. ‘Top-of-descent’ (in-flight spraying) is the second technique of this method and is carried out at ‘top-of-descent’, as the aircraft starts its descent to the destination airport. Air re-circulation shall be set at normal flow.
            No residual efficacy has been demonstrated.
            Products containing 1R-trans phenothrin should not be used for both pre-flight and in-flight treatment in the same aircraft.
            4.1.2.   Use-specific risk mitigation measures

                        —

                        The product should be applied only once per flight.

                        —

                        A member of the cabin crew shall perform no more than one application per day.

                        —

                        Do not use/apply the product directly on or near food, feed or drinks, or on surfaces or utensils likely to be in direct contact with food and drinks.

                        —

                        Contains 1R-trans phenothrin (pyrethroids), may be dangerous to cats. Care must be taken in using the product when cats are present in the aircraft. Cats must be kept away during treatment.

                        —

                        Cleaning of treated aircraft must only be undertaken using specialised products that do not require discharge of liquid waste to drains and local sewage treatment plants.

                        —

                        Cleaning equipment (brushes, cloths, etc.) used on an aircraft after application of the product must be disposed of as solid waste and must not be re-used.

                  4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            First Aid instructions:

               General

                        —

                        IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.

                        —

                        IF SWALLOWED: If symptoms occur call a POISON CENTRE or a doctor.

                        —

                        IF ON SKIN: Wash with soap and water. If symptoms occur call a POISON CENTRE or a doctor.

                        —

                        IF IN EYES: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If symptoms occur call a POISON CENTRE or a doctor.

                        —

                        Pyrethroids may cause paresthesia (burning and prickling of the skin without irritation). If symptoms persist: seek medical advice.

               Emergency measures to protect the environment in case of accident

                        —

                        Contain and control any leaks or spills with non-combustible absorbent materials such as sand, earth, vermiculite, or diatomaceous earth in drums for waste disposal.

                        —

                        Prevent any material from entering drains or waterways.

                        —

                        Do not direct water spray at the point of leakage or of spillage.

                        —

                        Allow any product remaining as a result of the leak or spill to evaporate.

                  4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

                        —

                        An appropriate entry should be made in the Aircraft General Declaration, giving details of the disinsection procedure together with the serial numbers of the spray cans used.

                        —

                        The empty spray cans are to be retained for inspection by the Port Health Authority.

                        —

                        Do not pour the product into drains or waterways.

                        —

                        Ensure that waste management is carried out without endangering human health, without harming the environment and, in particular, without risk to water, air, soil, plants or animals.

                        —

                        Recycle or dispose of waste product in compliance with applicable legislation, preferably via a certified collector or company.

                        —

                        Do not contaminate the ground or water with waste product.

                        —

                        Do not dispose of waste product into the environment.

                  4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

            See directions for use
            5.   GENERAL DIRECTIONS FOR USE (1)

            5.1.   Instructions for use

            See section 4.1.1
            5.2.   Risk mitigation measures

            See section 4.1.2
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            See section 4.1.3
            5.4.   Instructions for safe disposal of the product and its packaging

            See section 4.1.4
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

                        —

                        Store in original packagingin a cool (below 40 °C), dry and well-ventilated place. Protect from frost.

                        —

                        Store out of direct sunlight, even when empty.

                  Shelf life: 2 years
            6.   OTHER INFORMATION

               (1)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for all authorised uses.


title: Commission Implementing Regulation (EU) 2021/369 of 1 March 2021 establishing the technical specifications and procedures required for the system of interconnection of central registers referred to in Directive (EU) 2015/849 of the European Parliament and of the Council (Text with EEA relevance)

text:
                  2.3.2021

                  EN

                  Official Journal of the European Union

                  L 71/11

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/369
         of 1 March 2021
         establishing the technical specifications and procedures required for the system of interconnection of central registers referred to in Directive (EU) 2015/849 of the European Parliament and of the Council
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Directive (EU) 2015/849 of the European Parliament and of the Council of 20 May 2015 on the prevention of the use of the financial system for the purposes of money laundering or terrorist financing amending Regulation (EU) No 648/2012 of the European Parliament and of the Council, and repealing Directive 2005/60/EC of the European Parliament and of the Council and Commission Directive 2006/70/EC (1), and in particular Article 31a thereof,
         Whereas:

                     (1)

                     Member States are required to interconnect their national central beneficial ownership registers via the European Central Platform established by Article 22(1) of Directive (EU) 2017/1132 of the European Parliament and of the Council (2), and the interconnection should be set up in accordance with the technical specifications and procedures established by the implementing acts adopted by the Commission in accordance with Article 24 of that Directive. Nevertheless, the differences between the purpose, scope and content of the registers interconnected under Directive (EU) 2017/1132 and the central beneficial ownership registers established under Directive (EU) 2015/849 necessitate defining and adopting further technical specifications, measures and other requirements that ensure uniform conditions for the implementation of the system.

                     (2)

                     The measures provided for in this Regulation are in accordance with the opinion of the Committee on the Prevention of Money Laundering and Terrorism Financing,

               HAS ADOPTED THIS REGULATION:

            Article 1
            The technical specifications and procedures for the system of interconnection of registers referred to in Article 30 and 31 of Directive (EU) 2015/849 shall be as set out in the 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, 1 March 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 141, 5.6.2015, p. 73

            (2)  Directive (EU) 2017/1132 of the European Parliament and of the Council of 14 June 2017 relating to certain aspects of company law (OJ L 169, 30.6.2017, p. 46).

            ANNEX
            Setting out the technical specifications and procedures referred to in Article 1
            1.   Subject matter

            The Beneficial Ownership Registers Interconnection System (‘BORIS’) shall be established as a decentralised system interconnecting the central national beneficial ownership registers and the European e-Justice Portal (1) through the European Central Platform (2). BORIS shall serve as a central search service making available all information related to beneficial ownership in line with the provisions of Directive (EU) 2015/849. (3)

            2.   Definitions

                        (a)

                        ‘register’ means national central registers on beneficial ownership information referred to in Articles 30 and 31 of Directive (EU) 2015/849;

                        (b)

                        ‘qualified user’ means the users of BORIS referred to in points (a) and (b) of Article 30(5) and in points (a) and (b) of Article 31(4) of the Directive (EU) 2015/849;

                        (c)

                        ‘minimum mandatory information’ means the common set of information with the same structure and types in all registers in the Member States;

                        (d)

                        ‘additional information’ means the commonly predefined set of information that Member States may decide to share – in addition to the ‘minimum mandatory information’ – partly or entirely through BORIS;

                        (e)

                        ‘national registration number’ means the individual identity number attributed under national law to a company or other legal entity, or to a trust or a similar arrangement in the beneficial ownership register.

                  3.   The relationship of national registration number with the European Unique Identifier and company registration number

                        3.1.

                        The beneficial ownership register shall share with the European Central Platform the national registration number and, for companies, the European Unique Identifier (‘EUID’) attributed to them in the Business Registers Interconnection System (‘BRIS’) (4) as well as the company registration number, in case the latter is different from the national registration number. The company registration number shall be used to attribute the EUID to companies that do not have an EUID in BRIS. For other legal entities, trusts or similar arrangements, the EUID shall be attributed based on the national registration number.

                        3.2.

                        Users of BORIS shall be able to search companies, other legal entities, trusts or similar arrangements using the national registration number and the company registration number, if different from the national registration number.

                        3.3.

                        Member States may choose not to provide national registration numbers for trusts or similar legal arrangements. With regard to trusts or similar legal arrangements created under the law of the Member State where they are held in the beneficial ownership register, this derogation only applies for a period of five years counted from the date on which BORIS becomes operational.

                  4.   Methods of communication

            BORIS shall use service-based methods of electronic communication, such as web-services, for the purpose of interconnection of registers.
            The communication between the portal and the platform, and between a register and the platform, shall be one-to-one communication.
            5.   Communication protocols

            Secure internet protocols, such as HTTPS, shall be used for the communication between the portal, the platform and the registers.
            Standard communication protocols, such as Simple Object Access Protocol (SOAP), shall be used for the transmission of data and metadata.
            6.   Security standards

            For the communication and distribution of information via BORIS, the technical measures for ensuring minimum information technology security standards shall include:

                        (a)

                        measures to ensure confidentiality of information, including by using secure channels, such as HTTPS;

                        (b)

                        measures to ensure the integrity of data while being exchanged;

                        (c)

                        measures to ensure the non-repudiation of origin of the sender of information within BORIS and the non-repudiation of receipt of information;

                        (d)

                        measures to ensure logging of security events in line with recognised international recommendations for information technology security standards;

                        (e)

                        measures to ensure the authentication and authorisation of any qualified users and measures to verify the identity of systems connected to the portal, the platform or the registers within BORIS;

                        (f)

                        where necessary, measures to protect against automated searches and copying of registers, such as limiting the results returned by each register to a maximum number and using a CAPTCHA (5) functionality.

                  7.   Data to be exchanged in the framework of BORIS

                        7.1.

                        The set of information in the national registers concerning a corporate or other legal entity, or a trust or a similar type of legal arrangement is referred to as ‘BO record’. The ‘BO record’ includes data on the profile of the entity or arrangement concerned, on the person of the beneficial owner or owners of that entity or arrangement, as well as on the beneficial interest(s) held by those owners.

                        7.2.

                        In relation to a company or other legal entity, as well as in relation to a trust or a similar arrangement, data on the profile shall include information on the name, legal form, as well as the registration address and the national registration number, if any.

                        7.3.

                        Each Member State shall have the possibility to extend the minimum mandatory information with additional information. With regard to the beneficial owner and the beneficial interest held by him/her, minimum mandatory information shall consist of the data set out in the second subparagraph of Article 30(5) and in the second subparagraph of Article 31(4) of Directive (EU) 2015/849. With regard to the identity of the beneficial owner, additional information shall include at least the date of birth or contact details, as set out in the last sentence of Article 30(5) and third subparagraph of Article 31(4). The data from the BO record shall be modelled based on the established interface specification.

                        7.4.

                        The exchange of information shall also include messages necessary for the operation of the system, such as for acknowledgement of receipt, logging and reporting.

                  8.   Structure of the standard message format

            The exchange of information between the registers, the platform and the portal shall be based on standard data-structuring methods and shall be expressed in a standard message format such as XML (6).
            9.   Data for the platform

                        9.1.

                        In accordance with the interoperability requirements the services to be exposed by each register shall be unified and present the same interface in order to enable the interaction by the calling application, such as the platform, with one single kind of interface exposing a common set of data elements. Member States shall align their internal data structure using mapping tables or similar technical implementation to meet the requirements of the interface specifications to be provided by the Commission.

                        9.2.

                        The following type of data shall be provided for the platform to perform its functions:

                                    (a)

                                    data allowing for the identification of systems that are connected to the platform. Those data could consist of URLs or any other number or code uniquely identifying each system within BORIS;

                                    (b)

                                    any other operational data that is necessary for the platform to ensure the proper and efficient functioning of the search service and the interoperability of the registers with the platform. Those data may include code lists, reference data, glossaries and related translations of those metadata, as well as logging and reporting data.

                        9.3.

                        The data and metadata handled by the platform shall be processed and stored in line with the security standards set out in Section 5.

                  10.   Methods of operation of the system and information technology services provided by the platform

                        10.1

                        For the distribution and exchange of information, the system shall be based on the following technical method of operation:

                        10.2.

                        For the delivery of messages in the relevant language version, the European e-Justice Portal shall provide reference data artefacts, such as code lists, controlled vocabularies and glossaries. Where relevant, these shall be translated into the official languages of the Union. Where possible, recognised standards and standardised messages shall be used.

                        10.3.

                        The Commission shall share with the Member State further details on the technical method of operation and the implementation of the information technology services provided by the platform.

                  11.   Search criteria

                        11.1.

                        At least one country shall be selected when running a search.

                        11.2.

                        The portal shall provide the following harmonised criteria for the search:

                                    (a)

                                    with regard to the companies or other legal entities, the trusts or similar arrangements:

                                                (i)

                                                Name of the legal entity or arrangement;

                                                (ii)

                                                National registration number.
                                                The search criteria under (i) and (ii) can be used alternatively.

                                    (b)

                                    with regard to persons as beneficial owners:

                                                (i)

                                                First name and surname of the beneficial owner;

                                                (ii)

                                                Date of birth of the beneficial owner.
                                                The search criterion under (i) and (ii) shall be used cumulatively.

                        11.3.

                        Further search criteria may be available on the portal.

                  12.   Payment modalities and online registration

                        12.1.

                        For the particular data for which Member States charge fees and which are made available on the portal via BORIS, the system shall allow users to pay online by using widely used payment methods such as credit and debit cards.

                        12.2.

                        BORIS shall contain measures to ensure a possibility for an online registration in accordance with Article 30(5a) and Article 31(4a) of Directive (EU) 2015/849.

                  13.   Availability of services

                        13.1.

                        The service shall available be 24h/7 days, with an availability rate of BORIS of at least 98 % excluding scheduled maintenance.

                        13.2.

                        Member States shall notify the Commission of maintenance activities as follows:

                                    (a)

                                    5 working days in advance for maintenance operations that may cause an unavailability period of up to 4 hours;

                                    (b)

                                    10 working days in advance for maintenance operations that may cause an unavailability period of up to 12 hours;

                                    (c)

                                    30 working days in advance for infrastructure computer room maintenance, which may cause up to 6 days unavailability period per year.
                                    To the extent possible, maintenance operations shall be planned outside working hours (19.00–8.00 CET).

                        13.3.

                        Where Member States have fixed weekly service windows, they shall inform the Commission of the time and day of the week when such fixed weekly windows are planned. Without prejudice to the obligations in points (a) to (c) of the second paragraph, where Member State systems become unavailable during such a fixed window, Member States may choose not to notify the Commission.

                        13.4.

                        In case of unexpected technical failure causing unavailability of more than half an hour of the systems of Member States, they shall inform the Commission without delay during working hours (9.00–16.00 CET) of their system unavailability, and, if known, of the projected resuming of the service.

                        13.5.

                        In case of unexpected failure of the central platform or of the portal, the Commission shall inform Member States without delay during working hours (9.00–16.00 CET) of the unavailability of the platform or the portal, and if known, of the expected resuming of the service.

                  14.   Rules of transcription and transliteration

            Each Member State shall transcribe or transliterate the search requests targeted to them and the returned results in accordance with their national standards.

               (1)  Hereinafter: the portal.

               (2)  The European Central Platform (hereinafter: the platform) is established by Article 22(1) of Directive (EU) 2017/1132 of the European Parliament and of the Council of 14 June 2017 relating to certain aspects of company law (OJ L 169, 30.6.2017, p. 46).

               (3)  This being without prejudice to any additional functionalities BORIS might acquire in the future.

               (4)  Article 16(1) of Directive (EU) 2017/1132 of the European Parliament and of the Council of 14 June 2017 relating to certain aspects of company law and Article 8 of the Annex to Commission Implementing Regulation (EU) 2015/884 of 8 June 2015 establishing technical specifications and procedures required for the system of interconnection of registers established by Directive 2009/101/EC of the European Parliament and of the Council.

               (5)  ‘Completely Automated Public Turing test to tell Computers and Humans Apart’.

               (6)  Extensible Markup Language.