title: Commission Implementing Regulation (EU) 2019/2030 of 29 November 2019 granting a Union authorisation for the biocidal product family Pal IPA Product Family (Text with EEA relevance)

text:
                  4.12.2019

                  EN

                  Official Journal of the European Union

                  L 313/51

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/2030
         of 29 November 2019
         granting a Union authorisation for the biocidal product family ‘Pal IPA Product Family’
         (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 29 June 2016, Pal Hygiene Products Limited, submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named ‘Pal IPA Product Family’ of product-types 2 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of United Kingdom had agreed to evaluate the application. The application was recorded under the case number BC-DY025578-07 in the Register for Biocidal Products.

                     (2)

                     ‘Pal IPA Product Family’ contains propan-2-ol, 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 22 August 2018, 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 25 March 2019, the Agency submitted to the Commission an opinion (2), including the proposed terms and conditions of the authorisation, the draft summary of the biocidal product characteristics (‘SPC’) of ‘Pal IPA Product Family’ and the final assessment report on the biocidal product family in accordance with Article 44(3) of Regulation (EU) No 528/2012.

                     (5)

                     The opinion concludes that ‘Pal IPA Product Family’ is a ‘biocidal product family’ within the meaning of Article 3(1)(s) of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that subject to compliance with the proposed terms and conditions and the draft SPC, it meets the conditions laid down in Article 19(1) and (6) of that Regulation.

                     (6)

                     On 4 June 2019, 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 ‘Pal IPA Product Family’.

                     (8)

                     In the opinion the Agency also recommends that a long-term storage test at ambient temperature for wipes in their commercial packaging be conducted by the authorisation holder as a condition in the authorisation. The Commission agrees with that recommendation and considers that the submission of this test should be a condition relating to the making available on the market and use of the biocidal product family pursuant to Article 22(1) of Regulation (EU) No 528/2012. The Commission also considers that the fact that data is to be provided after the authorisation is granted does not affect the conclusion on the fulfilment of the condition under Article 19(1)(d) of that Regulation on the basis of the existing data.

                     (9)

                     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-0020463-0000 is granted to Pal Hygiene Products Limited for the making available on the market and use of the biocidal product family ‘Pal IPA Product Family’, subject to compliance with the terms and conditions set out in Annex I and in accordance with the summary of the biocidal product characteristics set out in the Annex II.
            The Union authorisation is valid from 24 December 2019 until 30 November 2029.

            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, 29 November 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  ECHA opinion of 28 February 2019 on the Union authorisation of ‘Pal IPA Product Family’ (ECHA/BPC/223/2019).

            ANNEX I

               TERMS AND CONDITIONS

               (EU-0020463-0000)

            The authorisation holder shall conduct a long-term storage test at ambient temperature for wipes in their commercial packaging.
            By 31 July 2021 the authorisation holder shall submit the results of the test to the Agency.

            ANNEX II

               SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY

            Pal IPA Product Family
            Product type 2 — Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
            Product type 4 — Food and feed area (Disinfectants)
            Authorisation number: EU-0020463-0000
            R4BP asset number: EU-0020463-0000
            PART I

               FIRST INFORMATION LEVEL

            1.   Administrative information

            1.1.   Family name

                        Name

                        Pal IPA Product Family

                  1.2.   Product type(s)

                        Product type(s)

                        PT02 — Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
                        PT04 — Food and feed area (Disinfectants)

                  1.3.   Authorisation holder

                        Name and address of the authorisation holder

                        Name

                        Pal Hygiene Products Limited

                        Address

                        Unit 5B & Unit 5H Fingal Bay Business Park, K32 NY57, Balbriggan, Co. Dublin, Ireland

                        Authorisation number

                        EU-0020463-0000

                           R4BP asset number

                        EU-0020463-0000

                        Date of the authorisation

                        24 December 2019

                        Expiry date of the authorisation

                        30 November 2029

                  1.4.   Manufacturer(s) of the biocidal products

                        Name of manufacturer

                        Pal International Limited

                        Address of manufacturer

                        Bilton Way, LE17 4JA Lutterworth, Leicestershire, United Kingdom

                        Location of manufacturing sites

                        Bilton Way, LE17 4JA Lutterworth, Leicestershire, United Kingdom

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

                        Active substance

                        Propan-2-ol

                        Name of manufacturer

                        Brenntag GmbH

                        Address of manufacturer

                        Messeallee 11, 45131 Essen, Germany

                        Location of manufacturing sites

                        Baton Rouge Chemical Plant (BRCP), Exxon Mobil Chemical Plant, 4999 Scenic Highway, 70897 Baton Rouge, Louisiana, United States

                        Active substance

                        Propan-2-ol

                        Name of manufacturer

                        Brenntag GmbH

                        Address of manufacturer

                        Messeallee 11, 45131 Essen, Germany

                        Location of manufacturing sites

                        Haven 3222, Vondelingenweg 601, 3196 KK Vondelingenplaat, Netherlands

                  2.   Product family composition and formulation

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

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Min

                        Max

                        Propan-2-ol

                        Active Substance

                        67-63-0

                        200-661-7

                        62,9

                        62,9

                  2.2.   Type(s) of formulation

                        Formulation(s)

                        AL (any other liquid) - RTU wipe

                  PART II

               SECOND INFORMATION LEVEL — META SPC(S)

               Meta SPC 1

            1.   Meta SPC 1 administrative information

            1.1.   Meta SPC 1 identifier

                        Identifier

                        Meta SPC 1 — Pal IPA Product Family Wipes

                  1.2.   Suffix to the authorisation number

                        Number

                        1-1

                  1.3.   Product type(s)

                        Product type(s)

                        PT02 — Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
                        PT04 — Food and feed area (Disinfectants)

                  2.   Meta SPC 1 Composition

            2.1.   Qualitative and quantitative information on the composition of the meta SPC 1

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Min

                        Max

                        Propan-2-ol

                        Active Substance

                        67-63-0

                        200-661-7

                        62,9

                        62,9

                  2.2.   Type(s) of formulation of the meta SPC 1

                        Formulation(s)

                        AL (any other liquid) - RTU wipe

                  3.   Hazard and precautionary statements of the meta SPC 1

                        Hazard statements

                        Highly flammable liquid and vapour.
                        Causes serious eye irritation.
                        May cause drowsiness or dizziness.
                        Repeated exposure may cause skin dryness or cracking.

                        Precautionary statements

                        If medical advice is needed, have product container or label at hand.
                        Keep out of reach of children.
                        Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
                        Keep container tightly closed.
                        Avoid breathing vapours.
                        Wash hands thoroughly after handling.
                        Use only outdoors or in a well-ventilated area.
                        Wear eye protection.
                        IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water.
                        IF INHALED: Remove person to fresh air and keep comfortable for breathing.
                        IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
                        Call a POISON CENTRE if you feel unwell.
                        If eye irritation persists: Get medical advice.
                        In case of fire: Use alcohol-resistant foam to extinguish.
                        Store in a well-ventilated place. Keep cool.
                        Store locked up.
                        Dispose of contents to/container in accordance with local regulations.

                  4.   Authorised use(s) of the meta SPC 1

            4.1.   Use description

               Table 1. Use # 1 — Professional use

                        Product type

                        PT02 — Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
                        PT04 — Food and feed area (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        -

                        Target organism(s) (including development stage)

                        Bacteria
                        Yeast
                        Mycobacteria

                        Field(s) of use

                        Indoor
                        Disinfectant for use against bacteria, mycobacteria and yeast on hard, non-porous surfaces in cleanrooms for biotechnology, pharmaceutical, manufacture of non-invasive medical devices, healthcare industries and other critical life science applications, and in industrial food and feed preparation areas

                        Application method(s)

                        Wiping

                        Application rate(s) and frequency

                        1 minute contact time for bacteria
                        1 minute contact time for mycobacteria
                        3 minute contact time for yeast

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

                        Impregnated 100 % polypropylene wipes in:

                                    —

                                    High-density polyethylene (HDPE) canister with Polypropylene (PP) lid – 150 wipes (0,5 L), 200 wipes (2 L), 240 wipes (2 L)

                                    —

                                    PP bucket with PP lid – 500 wipes (8 L), 1 000  wipes (8 L), 1 500  wipes (8 L)

                              Impregnated 100 % polyester wipes in:

                                    —

                                    laminate film flow wrap packet sealed with PET/PE – 25, 50 or 100 wipes

                                    —

                                    Aluminium foil – 1 wipe

                  4.1.1.   Use-specific instructions for use

            See general directions for use
            4.1.2.   Use-specific risk mitigation measures

            See general directions for use
            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

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

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

            See general directions for use
            5.   General directions for use (1)
               of the meta SPC 1

            5.1.   Instructions for use

            Do not use on surfaces sensitive to alcohol.
            Acceptable use temperature (10-20 °C)
            For soiled surfaces, clean the surface carefully before application:

                        1.

                        Follow agreed risk assessment policy guidelines regarding the use of Personal Protective Equipment.

                        2.

                        Choose the dispenser type and dispense the wipe.

                        3.

                        Wipe the surface in an S Shape moving from clean to dirty. Use the wipe flat not scrunched. Do not go over the same area twice with the same wipe.

                        4.

                        Use a fresh wipe if your wipe becomes soiled or dry.

                        5.

                        Make sure to wet surfaces completely

                        6.

                        Used wipes must be disposed in a closed container

                        7.

                        Allow the surface to dry before use.

                  5.2.   Risk mitigation measures

            Wash hands and exposed skin before meals and after use.
            Avoid contact with eyes.
            When performing disinfection in areas where members of the public may be present, persons should be prevented from entering the room until the room has been well ventilated.
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            Eye contact: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention
            5.4.   Instructions for safe disposal of the product and its packaging

            Dispose of contents/container in accordance with local regulations.
            Do not flush wipes down the toilet. Do not macerate.
            Residual alcohol should be emptied prior to disposal of container.
            Discard used wipes in the appropriate waste bin following local agreed guidelines.
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

            Store in a cool, dry, well-ventilated place in original container.
            Keep container tightly closed.
            Shelf-life: 2 years
            6.   Other information

            Polypropylene or polyester wipes, 20-45 gsm, containing 1,7-7,5 ml product (0,93-4,12 g propan-2-ol)
            The product contains propan-2-ol (CAS No: 67-63-0), for which an European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
            7.   Third information level: individual products in the meta SPC 1

            7.1.   Trade name(s), authorisation number and specific composition of each individual product

                        Trade name(s)

                        Medipal Alcohol Disinfectant Wipes
                        Pal Tech Precision 70 % IPA Wipes
                        Pal TX IPA Surface Disinfectant Wipes

                        Authorisation number

                        EU-0020463-0001 1-1

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Propan-2-ol

                        Active Substance

                        67-63-0

                        200-661-7

                        62,9

               (1)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 1.


title: Commission Implementing Regulation (EU) 2019/2076 of 29 November 2019 granting a Union authorisation for the biocidal product family Contec IPA Product Family (Text with EEA relevance)

text:
                  6.12.2019

                  EN

                  Official Journal of the European Union

                  L 316/19

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/2076
         of 29 November 2019
         granting a Union authorisation for the biocidal product family ‘Contec IPA Product Family’
         (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 29 June 2016, Contec Europe, submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named ‘Contec IPA Product Family’ of product-types 2 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of United Kingdom had agreed to evaluate the application. The application was recorded under the case number BC-LA025582-58 in the Register for Biocidal Products.

                     (2)

                     ‘Contec IPA Product Family’ contains propan-2-ol, 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 22 August 2018, 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 25 March 2019, the Agency submitted to the Commission an opinion (2), including the proposed terms and conditions of the authorisation, the draft summary of the biocidal product characteristics (‘SPC’) of ‘Contec IPA Product Family’ and the final assessment report on the biocidal product family in accordance with Article 44(3) of Regulation (EU) No 528/2012.

                     (5)

                     The opinion concludes that ‘Contec IPA Product Family’ is a ‘biocidal product family’ within the meaning of Article 3(1)(s) of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that subject to compliance with the proposed terms and conditions and the draft SPC, it meets the conditions laid down in Article 19(1) and (6) of that Regulation.

                     (6)

                     On 28 May 2019, 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 ‘Contec IPA Product Family’.

                     (8)

                     In the opinion the Agency also recommends that a long-term storage test at ambient temperature for wipes in their commercial packaging be conducted by the authorisation holder as a condition in the authorisation. The Commission agrees with that recommendation and considers that the submission of this test should be a condition relating to the making available on the market and use of the biocidal product family pursuant to Article 22(1) of Regulation (EU) No 528/2012. The Commission also considers that the fact that data is to be provided after the authorisation is granted does not affect the conclusion on the fulfilment of the condition under Article 19(1)(d) of that Regulation on the basis of the existing data.

                     (9)

                     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-0020460-0000 is granted to Contec Europe for the making available on the market and use of the biocidal product family ‘Contec IPA Product Family’, subject to compliance with the terms and conditions set out in Annex I and in accordance with the summary of the biocidal product characteristics set out in Annex II.
            The Union authorisation is valid from 26 December 2019 until 30 November 2029.

            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, 29 November 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  ECHA opinion of 28 February 2019 on the Union authorisation of ‘Contec IPA Product Family’ (ECHA/BPC/221/2019).

            ANNEX I

               TERMS AND CONDITIONS (EU-0020460-0000)

            The authorisation holder shall conduct a long-term storage test at ambient temperature for wipes in their commercial packaging.
            By 31 July 2021 the authorisation holder shall submit the results of the test to the Agency.

            ANNEX II

               Summary of product characteristics for a biocidal product family

            Contec IPA Product Family
            Product type 2 — Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
            Product type 4 — Food and feed area (Disinfectants)
            Authorisation number: EU-0020460-0000
            R4BP asset number: EU-0020460-0000
            PART I

               FIRST INFORMATION LEVEL

            1.   ADMINISTRATIVE INFORMATION
            1.1.   Family name

                        Name

                        Contec IPA Product Family

                  1.2.   Product type(s)

                        Product type(s)

                        PT02 — Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
                        PT04 — Food and feed area (Disinfectants)

                  1.3.   Authorisation holder

                        Name and address of the authorisation holder

                        Name

                        Contec Europe

                        Address

                        Zl Du Prat, Avenue Paul Duplaix, 56000, Vannes, France

                        Authorisation number

                        EU-0020460-0000

                           R4BP asset number

                        EU-0020460-0000

                        Date of the authorisation

                        26 December 2019

                        Expiry date of the authorisation

                        30 November 2029

                  1.4.   Manufacturer(s) of the biocidal products

                        Name of manufacturer

                        Contec Inc.

                        Address of manufacturer

                        525 Locust Grove, SC 29303 Spartanburg United States

                        Location of manufacturing sites

                        525 Locust Grove, SC 29303 Spartanburg United States

                        Name of manufacturer

                        Contec Cleanroom Technology (Suzhou) Co., Ltd. China

                        Address of manufacturer

                        17 Longyun Road, Suzhou Industrial Park, 215024 Suzhou China

                        Location of manufacturing sites

                        17 Longyun Road, Suzhou Industrial Park, 215024 Suzhou China

                        Name of manufacturer

                        Contec Cleanroom (UK) Ltd

                        Address of manufacturer

                        Unit 6A, Wansbeck Business Park, Rotary Parkway, NE63 8QW Ashington, Northumberland United Kingdom

                        Location of manufacturing sites

                        Unit 6A, Wansbeck Business Park, Rotary Parkway, NE63 8QW Ashington, Northumberland United Kingdom

                        Name of manufacturer

                        Flexible Medical Packaging

                        Address of manufacturer

                        Unit 8 Hightown, White Cross Industrial Estate, LA1 4XS Lancaster, Lancashire United Kingdom

                        Location of manufacturing sites

                        Unit 8 Hightown, White Cross Industrial Estate, LA1 4XS Lancaster, Lancashire United Kingdom

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

                        Active substance

                        Propan-2-ol

                        Name of manufacturer

                        Brenntag GmbH

                        Address of manufacturer

                        Messeallee 11, 45131 Essen, Germany

                        Location of manufacturing sites

                        Haven 3222, Vondelingenweg 601, 3196 KK Vondelingenplaat Netherlands

                  2.   PRODUCT FAMILY COMPOSITION AND FORMULATION
            2.1.   Qualitative and quantitative information on the composition of the family

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Min

                        Max

                        Propan-2-ol

                        Active Substance

                        67-63-0

                        200-661-7

                        62,9

                        62,9

                  2.2.   Type(s) of formulation

                        Formulation(s)

                        AL (any other liquid) - RTU solution/trigger spray
                        AL (any other liquid) – RTU wipe

                  PART II

               SECOND INFORMATION LEVEL — META SPC(S)

               META SPC 1

            1.   META SPC 1 ADMINISTRATIVE INFORMATION
            1.1.   Meta SPC 1 identifier

                        Identifier

                        Contec IPA Liquid Products

                  1.2.   Suffix to the authorisation number

                        Number

                        1-1

                  1.3.   Product type(s)

                        Product type(s)

                        PT02 — Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
                        PT04 — Food and feed area (Disinfectants)

                  2.   META SPC 1 COMPOSITION
            2.1.   Qualitative and quantitative information on the composition of the meta SPC 1

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Min

                        Max

                        Propan-2-ol

                        Active Substance

                        67-63-0

                        200-661-7

                        62,9

                        62,9

                  2.2.   Type(s) of formulation of the meta SPC 1

                        Formulation(s)

                        AL (any other liquid) - RTU solution/trigger spray

                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

                        Hazard statements

                        Highly flammable liquid and vapour.
                        Causes serious eye irritation.
                        May cause drowsiness or dizziness.
                        Repeated exposure may cause skin dryness or cracking.

                        Precautionary statements

                        If medical advice is needed, have product container or label at hand.
                        Keep out of reach of children.
                        Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
                        Keep container tightly closed.
                        Avoid breathing vapours.
                        Wash hands thoroughly after handling.
                        Use only outdoors or in a well-ventilated area.
                        Wear eye protection.
                        IF ON SKIN (or hair):Take off immediately all contaminated clothing. Rinse skin with water.
                        IF INHALED: Remove person to fresh air and keep comfortable for breathing.
                        IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
                        Call a Poison centre if you feel unwell.
                        If eye irritation persists: Get medical advice.
                        In case of fire: Use alcohol resistant foam to extinguish.
                        Store in a well-ventilated place. Keep cool.
                        Store locked up.
                        Dispose of contents/container in accordance with local regulations.

                  4.   AUTHORISED USE(S) OF THE META SPC 1
            4.1.   Use description

               Table 1

               Use # 1 – Professional use

                        Product type

                        PT02 — Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
                        PT04 — Food and feed area (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        Target organism(s) (including development stage)

                        Bacteria
                        Mycobacteria
                        Yeasts

                        Field(s) of use

                        Indoor
                        Disinfectant for use against bacteria, mycobacteria and yeast on hard, non-porous surfaces in cleanrooms for biotechnology, pharmaceutical, manufacture of medical devices, healthcare industries and other critical life science applications, and in industrial food and feed preparation areas.
                        Acceptable use temperature: room temperature (20±2 °C)

                        Application method(s)

                        Spraying and wiping

                        Application rate(s) and frequency

                        50 ml product per m2 of surface.
                        Wiping: 1 minute contact time for bacteria and myobacteria
                        3 minutes contact time for yeast

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

                        High-density polyethylene (HDPE) trigger spray bottle –0,5  L – 1 L
                        HDPE capped refill bottle – 5 L

                  4.1.1.   Use-specific instructions for use

            See general directions for use
            4.1.2.   Use-specific risk mitigation measures

            See general directions for use
            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

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

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

            See general directions for use
            5.   GENERAL DIRECTIONS FOR USE (1) OF THE META SPC 1
            5.1.   Instructions for use

            Use at room temperature. For visibly soiled surfaces, cleaning prior to disinfection is required.
            Wiping: Apply/Spray product to a suitable quality cleanroom wipe. Ensure the wipe is sufficiently and uniformly saturated before wiping the surface to be disinfected.
            Ensure the surface is uniformly covered with the product then wipe to dry with a sterile cleanroom wipe.
            Contact times: Wiping 1 minute for bacteria and mycobacteria 3 minutes for yeast.
            Used wipes must be disposed of in a closed container.
            5.2.   Risk mitigation measures

            Wash hands and exposed skin before meals and after use.
            Avoid contact with eyes
            ‘For use in cleanrooms, adequate technical/engineering controls to remove airborne residues is mandatory e.g. room ventilation or LEV’
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            Likely direct or indirect adverse effects:
            Headache, vertigo, hallucinations, respiratory depression, CNS depression or coma.
            Severe irritation of the eyes and or ocular damage.
            Nausea, vomiting, diarrhoea and haemorrhagic gastritis.
            Pulmonary aspiration hazard may induce pneumonitis, hypotension and hypoglycemia.
            First aid measures:
            Relocate the individual from the exposure source and remove any contaminated/spattered clothing articles.
            Eye contact: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention
            Skin contact; wash affected area with plenty of water and soap. No scrubbing.
            In case of ingestion: Do NOT induce vomiting and never give anything by mouth to an impaired or unconscious individual; if the individual is unconscious place individual in left sideways (recovery) position with the head lowered and the knees bent.
            Keep the individual calm and at rest, conserve body temperature and control breathing. If necessary check for pulse and initiate artificial respiration.
            Take the individual to a healthcare centre and bring packaging or label whenever possible.
            NEVER LEAVE THE AFFECTED INDIVIDUAL UNATTENDED!
            Advice for medical and healthcare personnel:
            Monitor vital signs and provide symptomatic and supportive treatment.
            Evaluate endoscopic procedure in case of ingestion.
            Monitor glycaemia and ketones.
            Ipecac use is contraindicated.
            WHEN ASKING FOR MEDICAL ADVICE KEEP PACKAGING OR LABEL AT HAND AND CALL YOUR LOCAL POISON CONTROL CENTRE [INSERT LOCAL NUMBER HERE].
            5.4.   Instructions for safe disposal of the product and its packaging

            Dispose of contents/container in accordance with local regulations.
            Do not re-use empty container for any other purpose.
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

            Store in a cool, dry, well-ventilated place in original container.
            Keep away from sources of ignition.
            Keep away from direct sunlight.
            Keep container tightly closed.
            Shelf-life: 2 years
            6.   OTHER INFORMATION
            The product contains propan-2-ol (CAS No: 67-63-0), for which an European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
            7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1
            7.1.   Trade name(s), authorisation number and specific composition of each individual product

                        Trade name(s)

                        Contec 70 % IPA FBC570I
                        Contec Sterile 70 % IPA SBT170IW
                        Contec Sterile 70 % IPA SBT0570IW
                        Contec 70 % IPA FBT170I

                        Authorisation number

                        EU-0020460-0001 1-1

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Propan-2-ol

                        Active Substance

                        67-63-0

                        200-661-7

                        62,9

               META SPC 2

            1.   META SPC 2 ADMINISTRATIVE INFORMATION
            1.1.   Meta SPC 2 identifier

                        Identifier

                        Contec IPA Wipes

                  1.2.   Suffix to the authorisation number

                        Number

                        1-2

                  1.3.   Product type(s)

                        Product type(s)

                        PT02 — Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
                        PT04 — Food and feed area (Disinfectants)

                  2.   META SPC 2 COMPOSITION
            2.1.   Qualitative and quantitative information on the composition of the meta SPC 2

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Min

                        Max

                        Propan-2-ol

                        Active Substance

                        67-63-0

                        200-661-7

                        62,9

                        62,9

                  2.2.   Type(s) of formulation of the meta SPC 2

                        Formulation(s)

                        AL (any other liquid) – RTU wipe

                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

                        Hazard statements

                        Highly flammable liquid and vapour.
                        Causes serious eye irritation.
                        May cause drowsiness or dizziness.
                        Repeated exposure may cause skin dryness or cracking.

                        Precautionary statements

                        If medical advice is needed, have product container or label at hand.
                        Keep out of reach of children.
                        Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
                        Keep container tightly closed.
                        Avoid breathing vapours.
                        Wash hands thoroughly after handling.
                        Use only outdoors or in a well-ventilated area.
                        Wear eye protection.
                        IF ON SKIN (or hair):Take off immediately all contaminated clothing. Rinse skin with water.
                        IF INHALED: Remove person to fresh air and keep comfortable for breathing.
                        IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
                        Call a POISON CENTRE if you feel unwell.
                        If eye irritation persists: Get medical advice.
                        In case of fire: Use alcohol resistant foam to extinguish.
                        Store in a well-ventilated place. Keep cool.
                        Store locked up.
                        Dispose of contents/container in accordance with local regulations.

                  4.   AUTHORISED USE(S) OF THE META SPC 2
            4.1.   Use description

               Table 2

               Use # 1 – Professional use

                        Product type

                        PT02 — Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
                        PT04 — Food and feed area (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        -

                        Target organism(s) (including development stage)

                        Bacteria
                        Mycobacteria
                        Yeasts

                        Field(s) of use

                        Indoor
                        Disinfectant for use against bacteria, mycobacteria and yeast on hard, non-porous surfaces in cleanrooms for biotechnology, pharmaceutical, manufacture of medical devices, healthcare industries and other critical life science applications, and in industrial food and feed preparation areas.
                        Acceptable use temperature: room temperature (20±2 °C)

                        Application method(s)

                        Wiping

                        Application rate(s) and frequency

                        1 minute contact time for bacteria and mycobacteria
                        3 minutes contact time for yeast

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

                        Impregnated 100 % polypropylene wipes in:

                                    —

                                    HDPE canister with HDPE cap – 150 wipes (1,7 L or 2,15 L)

                                    —

                                    Polyethylene terephthalate (PET)/polyethylene (PE) packet sealed with PET/PE flow wrap – 30, 40 or 50 wipes

                              Impregnated 100 % polyester wipes in:

                                    —

                                    HDPE canister with HDPE cap – 100 wipes (2,25 L)

                                    —

                                    PET/PE packet sealed with PET/PE flow wrap – 20 wipes

                              Impregnated 100 % knitted polyester wipes in:

                                    —

                                    PET/PE packet sealed with PET/PE flow wrap – 8, 10, 20, 30 or 50 wipes

                              Impregnated 55 % cellulose/45 % polyester wipes in:

                                    —

                                    HDPE canister with HDPE cap – 100 wipes (2,25 L)

                                    —

                                    PET/PE packet sealed with PET/PE flow wrap – 24, 30, 50 or 75 wipes

                              Impregnated 50 % rayon/50 % polyester wipes in:

                                    —

                                    HDPE canister with HDPE cap - 700 wipes (11,4 L)

                  4.1.1.   Use-specific instructions for use

            See general directions for use
            4.1.2.   Use-specific risk mitigation measures

            See general directions for use
            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

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

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

            See general directions for use
            5.   GENERAL DIRECTIONS FOR USE (2) OF THE META SPC 2
            5.1.   Instructions for use

            For soiled surfaces, cleaning prior to disinfection is required.
            Ensure the surface is uniformly covered with the product, allow to act for a contact time of 1 minute for bactericidal and mycobactericidal action and 3 minutes for yeasticidal action
            5.2.   Risk mitigation measures

            Wash hands and exposed skin before meals and after use.
            Avoid contact with eyes
            ‘For use in cleanrooms, adequate technical/engineering controls to remove airborne residues is mandatory e.g. room ventilation or LEV’
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            Likely direct or indirect adverse effects:
            Headache, vertigo, hallucinations, respiratory depression, CNS depression or coma.
            Severe irritation of the eyes and or ocular damage.
            Nausea, vomiting, diarrhoea and haemorrhagic gastritis.
            Pulmonary aspiration hazard may induce pneumonitis, hypotension and hypoglycemia.
            First aid measures:
            Relocate the individual from the exposure source and remove any contaminated/spattered clothing articles.
            Eye contact: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists: Get medical advice/attention
            Skin contact; wash affected area with plenty of water and soap, No scrubbing.
            In case of ingestion; Do NOT induce vomiting and never give anything by mouth to an impaired or unconscious individual; if the individual is unconscious place individual in left sideways (recovery) position with the head lowered and the knees bent.
            Keep the individual calm and at rest, conserve body temperature and control breathing. If necessary check for pulse and initiate artificial respiration.
            Take the individual to a healthcare centre and bring packaging or label whenever possible.
            NEVER LEAVE THE AFFECTED INDIVIDUAL UNATTENDED!
            Advice for medical and healthcare personnel:
            Monitor vital signs and provide symptomatic and supportive treatment.
            Evaluate endoscopic procedure in case of ingestion.
            Monitor glycaemia and ketones.
            Ipecac use is contraindicated.
            WHEN ASKING FOR MEDICAL ADVICE KEEP PACKAGING OR LABEL AT HAND AND CALL YOUR LOCAL POISON CONTROL CENTRE [INSERT LOCAL NUMBER HERE].
            5.4.   Instructions for safe disposal of the product and its packaging

            Dispose of contents/container in accordance with local regulations.
            Do not re-use empty container for any other purpose.
            Used wipes must be disposed in a closed container
            Dispose of used wipes by dry waste to landfill
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

            Store in a cool, dry, well-ventilated place in original container.
            Keep away from sources of ignition.
            Keep away from direct sunlight.
            Keep container tightly closed.
            Shelf-life: 2 years
            6.   OTHER INFORMATION
            Polypropylene, polyester, kitted polyester, 55 % cellulose/45 % polyester or 50 % rayon/50 % polyester wipes, 34-240 gsm, containing 5 - 38 ml product (2,75 – 20,9 g propan-2-ol)
            The product contains propan-2-ol (CAS No: 67-63-0), for which an European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.
            7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2
            7.1.   Trade name(s), authorisation number and specific composition of each individual product

                        Trade name(s)

                        PROSAT MBPP PS-840IR
                        PROSAT MBPP PS-911
                        PROSAT MBPP PS-911EB
                        PROSAT MBPP PS-LPP-7030
                        PROSAT MBPP PS-LPP-7030IR
                        PROSAT MBPP PSPP0039
                        PROSAT MBPP PSPP0043
                        SATWipes MBPP SWPP0003
                        PROSAT Delta PS-7030IR
                        SATWipes nonwoven polyester SAT-C3-7030
                        Spec-Wipe 4 115-0039
                        PROSAT Polynit Heatseal PS-HS9-7030
                        PROSAT EasyReach PSME0001
                        PROSAT Polynit Heatseal PSPS0047
                        PROSAT Polynit Heatseal PSPS0076
                        PROSAT Polynit Heatseal PSPS0091
                        PROSAT Polynit Heatseal PSWE0001
                        PROSAT Polynit Heatseal PSWE0002
                        PROSAT Polynit Heatseal PSWE0003
                        Spec-Wipe 3 115-0034
                        PROSAT Sigma PSC20001
                        PROSAT Sigma PSC20002
                        PROSAT Theta PSC20005
                        PROSAT Theta PSC20006
                        PROSAT Theta PSC20009
                        PROSAT Theta PSC20010
                        PROSAT Theta PSCP0001
                        PROSAT Theta PSCS1010
                        PROSAT Theta PSCS1010IR
                        SATWipes polyester/cellulose SAT-C1-7030
                        SATWipes presaturated wipes SWNW0013

                        Authorisation number

                        EU-0020460-0002 1-2

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Propan-2-ol

                        Active Substance

                        67-63-0

                        200-661-7

                        62,9

               (1)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 1.

               (2)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 2.


title: Commission Implementing Regulation (EU) 2020/150 of 4 February 2020 concerning the authorisation of the preparation of 6-phytase produced by Komagataella phaffii CGMCC 12056 as a feed additive for chickens for fattening, chickens reared for laying and for breeding and minor poultry species for fattening or reared for laying or for breeding purposes (holder of authorisation Andrés Pintaluba S.A.) (Text with EEA relevance)

text:
                  5.2.2020

                  EN

                  Official Journal of the European Union

                  L 33/9

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/150
         of 4 February 2020
         concerning the authorisation of the preparation of 6-phytase produced by Komagataella phaffii CGMCC 12056 as a feed additive for chickens for fattening, chickens reared for laying and for breeding and minor poultry species for fattening or reared for laying or for breeding purposes (holder of authorisation Andrés Pintaluba S.A.)
         (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 a preparation of 6-phytase produced by Komagataella phaffii CGMCC 12056. That application was accompanied by the particulars and documents required under Article 7(3) of that Regulation.

                     (3)

                     The application concerns the authorisation of a preparation of 6-phytase produced by Komagataella phaffii CGMCC 12056 as a feed additive for chickens for fattening, chickens reared for laying and minor poultry species for fattening or reared for laying or for breeding purposes to be classified in the additive category ‘zootechnical additives’.

                     (4)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 2 April 2019 (2) that, under the proposed conditions of use, the preparation of 6-phytase produced by Komagataella phaffii CGMCC 12056 does not have an adverse effect on animal health, consumer safety or the environment. It also concluded that the additive may have respiratory sensitisation potential. 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. It concluded that the additive has the potential to improve the utilisation of the phosphorus. 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 Reference Laboratory set up by Regulation (EC) No 1831/2003.

                     (5)

                     The assessment of the preparation of 6-phytase produced by Komagataella phaffii CGMCC 12056 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 preparation 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 preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘digestibility enhancers’, 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, 4 February 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

            (2)  EFSA Journal 2019; 17(4):5692.

            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

                        Unit of activity/kg of complete feedingstuff with a moisture content of 12 %

                           Category of zootechnical additives. Functional group: digestibility enhancers.

                        4a31

                        Andrés Pintaluba S.A.

                        6-phytase
                        EC 3.1.3.26

                           Additive composition

                        Preparation of 6-phytase (EC 3.1.3.26)
                        produced by Komagataella phaffii CGMCC 12056, having a minimum activity of:
                        Solid form: 20 000  U (1)/g
                        Liquid form: 20 000  U/ml

                        Chickens for fattening
                        Chickens reared for laying and breeding
                        Minor poultry species for fattening or reared for laying or for breeding purposes

                        -

                        250 U

                                    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, including breathing protection.

                        25 February 2030

                           Characterisation of the active substance

                        6-phytase produced by Komagataella phaffii CGMCC 12056

                           Analytical method
                            (2)

                        For the quantification of phytase activity in the feed additive: colorimetric method based on the enzymatic reaction of phytase on the phytate – VDLUFA 27.1.4;
                        For the quantification of phytase activity in premixtures: colorimetric method based on the enzymatic reaction of phytase on the phytate – VDLUFA 27.1.3;
                        For the quantification of phytase activity in feedingstuffs: colorimetric method based on the enzymatic reaction of phytase on the phytate – EN ISO 30024.

               (1)  One unit is the amount of enzyme which releases one micromole of inorganic phosphate from phytate per minute at pH 5,5 and 37 °C.

               (2)  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) 2020/424 of 19 March 2020 on submitting information to the Commission as regards non-application of technical specifications for interoperability in accordance with Directive (EU) 2016/797

text:
                  20.3.2020

                  EN

                  Official Journal of the European Union

                  L 84/20

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/424
         of 19 March 2020
         on submitting information to the Commission as regards non-application of technical specifications for interoperability in accordance with Directive (EU) 2016/797
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Directive (EU) 2016/797 of the European Parliament and of the Council of 11 May 2016 on the interoperability of the rail system within the European Union (1), and in particular Article 7(5) thereof,
         Whereas:

                     (1)

                     Article 7(1) of the Directive (EU) 2016/797 provides that Member States may allow an applicant not to apply one or more technical specifications for interoperability (‘TSIs’) or part of them, in cases, which are listed exhaustively in points (a) to (e) of the Article.

                     (2)

                     Member States’ communication of their decision in cases referred to in point (a) of Article 7(1), or Member States’ request for non-application in the cases referred to in points (c), (d) and (e), should contain information justifying the non-application and specifying the alternative provisions to be applied instead of the TSIs.

                     (3)

                     The request should include the reference to the non-applied TSI provisions, describe the project concerned, its scope and timelines as well as provide any other relevant information to assist the Commission in assessing the compliance of the non-application with the requirements set out in Article 7(1).

                     (4)

                     Once transitional measures provided by a TSI expire, Member States should permit applicants not to apply the TSI or parts of them pursuant to Article 7(1)(a) of the Directive only in duly justified case. In that event, the communication to the Commission should include all necessary information and justifications.

                     (5)

                     In order to facilitate communication with the Commission, Member States should use a template when they submit their non-application decision for a project at an advanced stage of development pursuant to point (a) of Article 7(1). This template could also be used for the notification of a list of projects at an advanced stage of development pursuant to Article 7(2) of the Directive.

                     (6)

                     The request for non-application of one or more TSIs or parts of them should be sent to the Commission by electronic means in order to ensure a paperless administration. The date by which Member States are delivering a request or supplement information to the Commission’s mailbox should be the submission date for the purpose of Article 7(7) of the Directive.

                     (7)

                     The measures provided for in this Regulation are in accordance with the opinion of the Rail Interoperability and Safety Committee,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Scope
            This Regulation establishes the information to be included in, and the format and the method to be used for the transmission of a request for non-application of one or more technical specifications for interoperability (‘TSIs’) or parts of them within the meaning of Article 7(4) of Directive (EU) 2016/797 (hereafter ‘request for non-application’), in accordance to which Member States shall either, communicate to the Commission a decision of non-application under point (a), or submit to the Commission a request for non-application under points (c), (d) or (e) of Article 7(1) of the Directive.

            Article 2
            Information contained in the request for non-application

               1.   A request for non-application shall contain the following information:

                           (a)

                           a reference to the case referred to in Article 7(1) of Directive (EU) 2016/797 under which the non-application is considered to be justified;

                           (b)

                           the reference to the title(s) of the TSI or TSIs covered by the request for non-application and to the provision(s) not applied. Each reference shall include, where relevant for assessing compliance, the time period or an estimate thereof, during which the non-application will continue;

                           (c)

                           the essential details of the project concerned, consisting of the technical, operational and geographical elements of the project, including a detailed description of the subsystem, vehicle or infrastructure requested to benefit from the non-application, and relevant key dates, or any other details distinguishing it from other projects;

                           (d)

                           a reference to and details of the alternative provisions that the Member State intends to apply to compensate each non-application in the light of relevant essential requirements, including the measures to be taken to monitor their implementation and, where operational alternatives were agreed, their continuous application;

                           (e)

                           where more than one Member State is concerned, information on coordination taking place in accordance with the final sentence in Article 7(4) of Directive (EU) 2016/797 and/or Article 17(2) of Commission Implementing Regulation (EU) 2018/545 (2), when requests for non-application are linked to vehicle authorisations; the same information shall be provided for cross border infrastructure projects;

                           (f)

                           an economic or technical analysis or both, ensuring that the non-application is justified and limited to the extent necessary under the particular circumstances.

               2.   The request for non-application shall also provide the following specific information:

                           (a)

                           for requests made pursuant to point (a) of Article 7(1) of Directive (EU) 2016/797, the justification shall include:

                                       (i)

                                       the details of the project concerned, using the template established in the Annex. If the project is already on a list of advanced stage of development drawn up according to the same template, Member States may refer to it without having to re-submit the information already provided. The information shall be updated where relevant;

                                       (ii)

                                       evidence that the project is at an advanced stage of development or subject to a contract in course of performance, with documentation providing the evidence for relevant dates and scope of the project;

                                       (iii)

                                       evidence that the planning or construction stage of a project at an advanced stage of development has reached a point where a change in the technical specifications may compromise the viability of the project as planned, in accordance with the definition of ‘project at advanced stage of development’ in Article 2(23) of Directive (EU) 2016/797;

                           (b)

                           for requests made pursuant to point (c) of Article 7(1) of Directive (EU) 2016/797, the justification shall include, depending on the nature of the non-application requested:

                                       (i)

                                       evidence that the application of one or more TSIs or part of them compromises the economic viability of the project. This evidence shall include a thorough economic analysis establishing unavoidable costs of compliance with the TSI, and providing evidence that such cost would render the project unviable. The analysis shall take into account exploitation revenue if the non-application allows earlier deployment and the longer term economic viability of the project within the national and European rail system; and/or

                                       (ii)

                                       evidence of the technical details justifying the negative impact of the application of one or more TSIs or part of them, on the project’s technical compatibility with the national rail system;

                           (c)

                           for requests made pursuant to point (d) of Article 7(1) of Directive (EU) 2016/797, the justification shall include a list of the Member States and third countries concerned and the railway lines where the vehicles covered by the request are circulating;

                           (d)

                           for requests made pursuant to point (e) Article 7(1), the justification shall identify the network or network area(s) relevant for the request and justify its separation from the rail network of the rest of the Union, and/or its isolation.

            Article 3
            Format and method of transmission

               1.   The request for non-application shall be limited to 10 pages maximum. Supplementing information may be added through annexes to the request.

               2.   A communication or request for non-application and any subsequent information to complete the file shall be submitted by electronic means only, to the dedicated mail address of the Commission:
               MOVE-RAIL-DEROGATIONS@ec.europa.eu

               3.   The date for the purpose of Article 7(7) of Directive (EU) 2016/797 is the date when the request or subsequent information to complete the file was submitted by mail according to paragraph 2.

               4.   The acknowledgement of receipt issued by the Commission to the Member State within 7 days will contain a unique identifier with reference to the Member State concerned, the project and the year of submission.
               Member State shall refer to the unique identifier, whenever communicating with the Commission on the non-application case.

            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 apply from 16 September 2020.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 19 March 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 138, 26.5.2016, p. 44.

            (2)  Commission Implementing Regulation (EU) 2018/545 of 4 April 2018 establishing practical arrangements for the railway vehicle authorisation and railway vehicle type authorisation process pursuant to Directive (EU) 2016/797 of the European Parliament and of the Council (OJ L 90, 6.4.2018, p. 66).

            ANNEX
            Template for presenting a project at an advanced stage of development where the non-application of one or more TSIs or part of them is requested for this project under point (a) of Article 7(1) of Directive (EU) 2016/797 and in line with the information requested with Article 2, points 1. and 2(a) of this Regulation

                        Name of the project

                        Details concerning the scope of the project

                        All dates and actions relevant for justifying the advanced state of development character or the contract signed

                        Technical specifications not applied and alternative provisions and/or standards applied

                        Any other relevant information, such as area(s) of use, including coordination in accordance with Art. 17(2) of Implementing Regulation (EU) 2018/545.

                        Information to justify the non-viability of the project

                        Derogations already granted to that project (if any)


title: Commission Implementing Regulation (EU) 2020/541 of 7 April 2020 entering a name in the register of protected designations of origin and protected geographical indications (‘Győr-Moson-Sopron megyei Csemege sajt’ (PGI))

text:
                  20.4.2020

                  EN

                  Official Journal of the European Union

                  L 121/3

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/541
         of 7 April 2020
         entering a name in the register of protected designations of origin and protected geographical indications (‘Győr-Moson-Sopron megyei Csemege sajt’ (PGI))
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (1), and in particular Article 52(2) thereof,
         Whereas:

                     (1)

                     Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, Hungary’s application to register the name ‘Győr-Moson-Sopron megyei Csemege sajt’ was published in the Official Journal of the European Union (2).

                     (2)

                     As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Győr-Moson-Sopron megyei Csemege sajt’ should therefore be entered in the register,

               HAS ADOPTED THIS REGULATION:

            Article 1
            The name ‘Győr-Moson-Sopron megyei Csemege sajt’ (PGI) is hereby entered in the register.
            The name specified in the first paragraph denotes a product in Class 1.3. – Cheeses, as listed in Annex XI to Commission Implementing Regulation (EU) No 668/2014 (3).

            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, 7 April 2020.

                  For the Commission,

                  On behalf of the President,

               Janusz WOJCIECHOWSKI

                  Member of the Commission

            (1)  OJ L 343, 14.12.2012, p. 1.

            (2)  OJ C 408, 4.12.2019, p. 8.

            (3)  Commission Implementing Regulation (EU) No 668/2014 of 13 June 2014 laying down rules for the application of Regulation (EU) No 1151/2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs (OJ L 179, 19.6.2014, p. 36).


title: Commission Implementing Regulation (EU) 2020/544 of 20 April 2020 amending Annex I to Regulation (EC) No 798/2008 as regards the entry for the United States in the list of third countries, territories, zones or compartments from which certain poultry commodities may be imported into or transit through the Union in relation to highly pathogenic avian influenza (Text with EEA relevance)

text:
                  20.4.2020

                  EN

                  Official Journal of the European Union

                  LI 121/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/544
         of 20 April 2020
         amending Annex I to Regulation (EC) No 798/2008 as regards the entry for the United States in the list of third countries, territories, zones or compartments from which certain poultry commodities may be imported into or transit through the Union in relation to highly pathogenic avian influenza
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption (1), and in particular the introductory phrase of Article 8, the first subparagraph of point 1 of Article 8, point 4 of Article 8 and Article 9(4) thereof,
         Having regard to Council Directive 2009/158/EC of 30 November 2009 on animal health conditions governing intra-Community trade in, and imports from third countries of, poultry and hatching eggs (2), and in particular Articles 23(1), 24(2) and 25(2) thereof,
         Whereas:

                     (1)

                     Commission Regulation (EC) No 798/2008 (3) lays down veterinary certification requirements for imports into and transit, including storage during transit, through the Union of poultry and poultry products (‘the commodities’). It provides that the commodities are only to be imported into and transit through the Union from the third countries, territories, zones or compartments listed in columns 1 and 3 of the table in Part 1 of Annex I thereto.

                     (2)

                     Regulation (EC) No 798/2008 also lays down the conditions for a third country, territory, zone or compartment to be considered as free from highly pathogenic avian influenza (HPAI).

                     (3)

                     The United States is listed in Part 1 of Annex I to Regulation (EC) No 798/2008 as a third country from which imports into and transit through the Union of the commodities are not restricted due to the presence of HPAI.

                     (4)

                     The Agreement between the European Community and the United States of America on sanitary measures to protect public and animal health in trade in live animals and animal products (‘the Agreement’) (4), approved by Council Decision 98/258/EC (5), provides for the mutual recognition of regionalisation measures in the event of outbreaks of a disease in the Union or in the United States.

                     (5)

                     On 8 April 2020, the United States confirmed the presence of HPAI of subtype H7N3 in a poultry holding in Chesterfield County in the State of South Carolina. The whole territory of the Unites States may, therefore, no longer be considered as being free from that disease.

                     (6)

                     The veterinary authorities of the United States placed a 10 km control zone around the affected holding, which included parts of Chesterfield, Lancaster and Kershaw counties in the State of South Carolina. The veterinary authorities of the United States confirmed that they immediately suspended issuing veterinary certificates for consignments of commodities intended for export to the Union from the whole of the territory of the United States and implemented a stamping-out policy in order to control HPAI and limit the spread of that disease.

                     (7)

                     The United States has submitted information on the epidemiological situation on its territory and the measures it has taken to prevent the further spread of HPAI which has now been evaluated by the Commission. On the basis of that evaluation, as well as the commitments laid down in the Agreement and the guarantees provided by the United States, in order to safeguard the Union against the animal health risks associated with the introduction into the Union of commodities from the United States, it is appropriate to place restrictions on the introduction into the Union of commodities from the area in the State of South Carolina affected by HPAI, which the veterinary authorities of the United States have placed under restrictions due to the current outbreak.

                     (8)

                     The entry for the United States in the table set out in Part 1 of Annex I to Regulation (EC) No 798/2008 should therefore be amended to take account of the current epidemiological situation in that third country due to the current outbreak of HPAI. Annex I to Regulation (EC) No 798/2008 should therefore be amended accordingly.

                     (9)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            Part 1 of Annex I to Regulation (EC) No 798/2008 is amended in accordance with the Annex to this Regulation.

            Article 2
            This Regulation shall enter into force on the third 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, 20 April 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 18, 23.1.2003, p. 11.

            (2)  OJ L 343, 22.12.2009, p. 74.

            (3)  Commission Regulation (EC) No 798/2008 of 8 August 2008 laying down a list of third countries, territories, zones or compartments from which poultry and poultry products may be imported into and transit through the Community and the veterinary certification requirements (OJ L 226, 23.8.2008, p. 1).

            (4)  OJ L 118, 21.4.1998, p. 3.

            (5)  Council Decision 98/258/EC of 16 March 1998 on the conclusion of the Agreement between the European Community and the United States of America on sanitary measures to protect public and animal health in trade in live animals and animal products (OJ L 118, 21.4.1998, p. 1).

            ANNEX
            In Part 1 of Annex I to Regulation (EC) No 798/2008, the entry for the United States is replaced by the following:

                           ISO code and name of third country or territory

                           Code of third country, territory, zone or compartment

                           Description of third country, territory, zone or compartment

                           Veterinary certificate

                           Specific conditions

                           Specific conditions

                           Avian influenza surveillance status

                           Avian influenza vaccination status

                           Salmonella Control Status (6)

                           Model(s)

                           Additional guarantees

                           Closing date(1)

                           Opening date(2)

                           1

                           2

                           3

                           4

                           5

                           6

                           6A

                           6B

                           7

                           8

                           9

                           ‘US – United States

                           US-0

                           Whole country

                           SPF

                           EP, E

                           S4

                           US-1

                           The whole country of the United States excluding area US-2

                           WGM

                           VIII

                           POU, RAT

                           N

                           BPP, BPR, DOC, DOR, HEP, HER, SRP, SRA, LT20

                           A

                           S3, ST1

                           US-2

                           Territory of the United States corresponding to:

                           US-2.1

                           State of Tennessee:

                                       Lincoln County

                                       Franklin County

                                       Moore County

                           WGM

                           VIII

                           P2

                           4.3.2017

                           11.8.2017

                           POU, RAT

                           N
                           P2

                           BPR, BPP, DOC, DOR, HEP, HER, SRP, SRA, LT20

                           A

                           S3, ST1

                           US-2.2

                           State of Alabama:

                                       Madison County

                                       Jackson County

                           WGM

                           VIII

                           P2

                           4.3.2017

                           11.8.2017

                           POU, RAT

                           N
                           P2

                           BPR, BPP, DOC, DOR, HEP, HER, SRP, SRA, LT20

                           A

                           S3, ST1

                           US-2.3

                           State of South Carolina:
                           Chesterfield county/Lancaster county/Kershaw county:
                           A zone of a 10 km radius starting with N point on the circular Chesterfield 02 premise Control Zone border and extending in a clockwise fashion:

                                       (a)

                                       North: 2 km south from Highway 9, 0,03 km east from intersection of Airport Rd and Raymond Deason Rd.

                                       (b)

                                       Northeast: 1 km southwest from intersection of Highway 268 and Cross Roads Church Rd.

                                       (c)

                                       East: 5,1 km west from State Highway 109, 1,6 km west from Angelus Rd and Refuge Dr

                                       (d)

                                       Southeast: 3,2 km northwest from intersection of Highway 145 and Lake Bee Rd.

                                       (e)

                                       South: 2,7 km east from intersection of Highway 151 and Catarah Rd.

                                       (f)

                                       Southwest: 1,5 km east from intersection of McBee Hwy and Mt Pisgah Rd.

                                       (g)

                                       West: 1,3 km east from intersection of Texahaw Rd and Buzzards Roost Rd.

                                       (h)

                                       Northwest: Intersection of White Plains Church Rd and Graves Rd.

                           WGM

                           VIII

                           P2

                           8.4.2020

                           POU, RAT

                           N
                           P2

                           BPR, BPP, DOC, DOR, HEP, HER, SRP, SRA, LT20

                           A

                           S3, ST1’


title: Commission Implementing Regulation (EU) 2020/1028 of 15 July 2020 fixing the closing date for the submission of applications for private storage aid for fresh or chilled meat of bovine animals aged eight months or more under Implementing Regulation (EU) 2020/596

text:
                  16.7.2020

                  EN

                  Official Journal of the European Union

                  L 227/8

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1028
         of 15 July 2020
         fixing the closing date for the submission of applications for private storage aid for fresh or chilled meat of bovine animals aged eight months or more under Implementing Regulation (EU) 2020/596
         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 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 18(2) thereof,
         Whereas:

                     (1)

                     Private storage aid granted pursuant to Commission Implementing Regulation (EU) 2020/596 (2) has had a favourable effect on the beef market.

                     (2)

                     Commission Implementing Regulation (EU) 2020/1006 (3) has suspended applications for private storage aid for five working days.

                     (3)

                     The granting of private storage aid for fresh or chilled meat of bovine animals aged eight months or more should therefore end and a closing date for the submission of applications should be set.

                     (4)

                     For the sake of legal certainty, Implementing Regulation (EU) 2020/596 should be repealed.

                     (5)

                     In order to avoid speculation, this Regulation should enter into force on the day of its publication in the Official Journal of the European Union.

                     (6)

                     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 closing date for the submission of applications for private storage aid for fresh or chilled meat of bovine animals aged eight months or more under Implementing Regulation (EU) 2020/596 shall be 17 July 2020.

            Article 2
            Implementing Regulation (EU) 2020/596 is repealed with effect from 17 July 2020.
            However, it shall continue to apply in respect of contracts concluded under that Regulation prior to the date of entry into force of this Regulation.

            Article 3
            This Regulation shall enter into force on the day 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, 15 July 2020.

                  For the Commission,

                  On behalf of the President,

               Wolfgang BURTSCHER

                  Director-General

                  Directorate-General for Agriculture and Rural Development

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

            (2)  Commission Implementing Regulation (EU) 2020/596 of 30 April 2020 granting aid for private storage for fresh and chilled meat of bovine animals aged eight months or more and fixing the amount of aid in advance (OJ L 140, 4.5.2020, p. 26).

            (3)  Commission Implementing Regulation (EU) 2020/1006 of 9 July 2020 suspending the submission of applications for private storage aid for fresh or chilled meat of bovine animals aged eight months or more under Implementing Regulation (EU) 2020/596 (OJ L 223, 10.7.2020, p. 1).


title: Commission Implementing Regulation (EU) 2020/1029 of 15 July 2020 fixing the closing date for the submission of applications for private storage aid for sheepmeat and goatmeat under Implementing Regulation (EU) 2020/595

text:
                  16.7.2020

                  EN

                  Official Journal of the European Union

                  L 227/10

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1029
         of 15 July 2020
         fixing the closing date for the submission of applications for private storage aid for sheepmeat and goatmeat under Implementing Regulation (EU) 2020/595
         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 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 18(2) thereof,
         Whereas:

                     (1)

                     Private storage aid granted pursuant to Commission Implementing Regulation (EU) 2020/595 (2) has had a favourable effect on the sheepmeat and goatmeat market.

                     (2)

                     Commission Implementing Regulation (EU) 2020/1007 (3) has suspended applications for private storage aid for five working days.

                     (3)

                     The granting of private storage aid for sheepmeat and goatmeat should therefore end and a closing date for the submission of applications should be set.

                     (4)

                     For the sake of legal certainty, Implementing Regulation (EU) 2020/595 should be repealed.

                     (5)

                     In order to avoid speculation, this Regulation should enter into force on the day of its publication in the Official Journal of the European Union.

                     (6)

                     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 closing date for the submission of applications for private storage aid for sheepmeat and goatmeat under Implementing Regulation (EU) 2020/595 shall be 17 July 2020.

            Article 2
            Implementing Regulation (EU) 2020/595 is repealed with effect from 17 July 2020.
            However, it shall continue to apply in respect of contracts concluded under that Regulation prior to the date of entry into force of this Regulation.

            Article 3
            This Regulation shall enter into force on the day 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, 15 July 2020.

                  For the Commission,

                  On behalf of the President,

               Wolfgang BURTSCHER

                  Director-General

                  Directorate-General for Agriculture and Rural Development

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

            (2)  Commission Implementing Regulation (EU) 2020/595 of 30 April 2020 granting aid for private storage for sheepmeat and goatmeat and fixing the amount of aid in advance (OJ L 140, 4.5.2020, p. 21).

            (3)  Commission Implementing Regulation (EU) 2020/1007 of 9 July 2020 suspending the submission of applications for private storage aid for sheepmeat and goatmeat under Implementing Regulation (EU) 2020/595 (OJ L 223, 10.7.2020, p. 3).