title: Commission Implementing Regulation (EU) 2021/552 of 30 March 2021 granting a Union authorisation for the biocidal product family ‘DEC-AHOL® Product Family’ (Text with EEA relevance)

text:
                  31.3.2021

                  EN

                  Official Journal of the European Union

                  L 111/13

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/552
         of 30 March 2021
         granting a Union authorisation for the biocidal product family ‘DEC-AHOL® 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, Veltek Associates Inc. Europe submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named ‘DEC-AHOL® Product Family’ of product-type 2, as described in Annex V to that Regulation, providing written confirmation that the competent authority of the Netherlands had agreed to evaluate the application. The application was recorded under case number BC-XF025530-45 in the Register for Biocidal Products.

                     (2)

                     ‘DEC-AHOL® 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 9 December 2019, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, the assessment report and the conclusions of its evaluation to the European Chemicals Agency (‘the Agency’).

                     (4)

                     On 2 July 2020, the Agency submitted to the Commission an opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘DEC-AHOL® 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 ‘DEC-AHOL® 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 draft SPC, it meets the conditions laid down in Article 19(1) and (6) of that Regulation.

                     (6)

                     On 20 July 2020, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.

                     (7)

                     The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘DEC-AHOL® Product Family’.

                     (8)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            A Union authorisation with authorisation number EU-0024324-0000 is granted to Veltek Associates Inc. Europe for the making available on the market and use of the biocidal product family ‘DEC-AHOL® Product Family’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
            The Union authorisation is valid from 20 April 2021 until 31 March 2031.

            Article 2
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 30 March 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

            (2)  ECHA opinion of 17 June 2020 on the Union authorisation of ‘DEC-AHOL® Product Family’ (ECHA/BPC/261/2020),https://echa.europa.eu/bpc-opinions-on-union-authorisation.

            ANNEX
            Summary of product characteristics for a biocidal product family
            DEC-AHOL® Product Family
            Product type 2 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
            Authorisation number: EU-0024324-0000
            R4BP asset number: EU-0024324-0000
            PART I

               FIRST INFORMATION LEVEL

            1.   ADMINISTRATIVE INFORMATION

            1.1.   Family name

                        Name

                        DEC-AHOL® Product Family

                  1.2.   Product type(s)

                        Product type(s)

                        PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

                  1.3.   Authorisation holder

                        Name and address of the authorisation holder

                        Name

                        Veltek Associates Inc. Europe

                        Address

                        Rozengaard 1940, 8212DT Lelystad, Netherlands

                        Authorisation number

                        EU-0024324-0000

                           R4BP asset number

                        EU-0024324-0000

                        Date of the authorisation

                        20 April 2021

                        Expiry date of the authorisation

                        31 March 2031

                  1.4.   Manufacturer(s) of the biocidal products

                        Name of manufacturer

                        Veltek Associates, Inc.

                        Address of manufacturer

                        15 Lee Blvd., PA19355 Malvern United States

                        Location of manufacturing sites

                        15 Lee Blvd., PA19355 Malvern United States

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

                        Active substance

                        Propan-2-ol

                        Name of manufacturer

                        Exxon Mobil Chemical Company

                        Address of manufacturer

                        4045 Scenic Hwy, Baton Rouge, LA 70805 Louisiana United States

                        Location of manufacturing sites

                        4045 Scenic Hwy, Baton Rouge, LA 70805 Louisiana United States

                  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

                        64,8

                        65,4

                  2.2.   Type(s) of formulation

                        Formulation(s)

                        AL – Any other liquid
                        AE – Aerosol dispenser
                        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

                  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)

                  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

                        65,4

                        65,4

                  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

                        Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
                        Avoid breathing vapours.
                        Wash hands thoroughly after handling.
                        Wear protective gloves.
                        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 doctor if you feel unwell.
                        If eye irritation persists: Get medical advice.
                        Store in a well-ventilated place. Keep container tightly closed.
                        Store locked up.
                        Dispose of contents in accordance with local/national regulations.
                        Wear eye protection.

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

            4.1.   Use description

               Table 1. Use # 1 – Disinfection of hard non-porous surfaces; Wipes (individual wipes and multi-pack wipes)

                        Product type

                        PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        -

                        Target organism(s) (including development stage)

                        Common name: Bacteria
                        Development stage: -
                        Common name: Yeast
                        Development stage: -

                        Field(s) of use

                        Indoor
                        Disinfectant wipe for use in cleanrooms of pharmaceutical, biopharmaceutical, medical device and diagnostic product manufacturing facilities for the disinfection of hard non-porous inanimate surfaces, materials and equipment which are not used for direct contact with food or feeding stuffs.

                        Application method(s)

                        Wiping of surfaces

                        Application rate(s) and frequency

                        Ready to Use (RTU)
                        Product may be used multiple times a day, if required.
                        Contact time: 2 min
                        Individual wipes:
                        15,2 cm × 15,2 cm wipe – 4 wipes per m2

                        30,5 cm × 30,5 cm wipe – 1 wipe per m2

                        45,7 cm × 45,7 cm wipe – 1 wipe per m2

                        Multi pack wipes:
                        30,5 cm × 30,5 cm – 1 wipe per m2

                        Category(ies) of users

                        Industrial

                        Pack sizes and packaging material

                        Pre-saturated 70 % v/v propan-2-ol and water for injection (WFI) wipes.
                        Individual wipes
                        A wipe is composed of 100 % continuous filament polyester fibre. The wipes are packaged in individual heat-sealed plastic bags made of low density polyethylene.
                        Pack sizes:
                        15,2 cm × 15,2 cm wipe – 100/case, non- Sterile
                        15,2 cm × 15,2 cm wipe – 100/case, sterile
                        30,5 cm × 30,5 cm wipe – 100/case, sterile
                        45,7 cm × 45,7 cm wipe – 100/case, sterile
                        Multi pack wipes
                        A wipe is composed of 100 % continuous filament knitted polyester fibre; 20 wipes per pack; folded together in a re-closable bag package.
                        Pack sizes:
                        100 % polyester 30,5 cm × 30,5 cm wipe – 200/case, non-sterile
                        100 % polyester 30,5 cm × 30,5 cm wipe – 200/case, sterile

                  4.1.1.   Use-specific instructions for use

            Use product only in cleanrooms which are classified according to ISO 14644-1 in class 1 to 9 or according to Good Manufacturing Practice (GMP) EU classification in grade A to D.
            Clean and dry surfaces prior to disinfection. Only use wet wipes. Remove one or two wipes at a time for individual wipes and one wipe at a time for multipack wipes. Make sure to wet surfaces completely. Allow to take effect for at least 2 minutes. Discard wipe after use in a closed container and for multipack wipes close the package after opening.
            Individual wipes:

                        15,2 cm × 15,2 cm wipe – 4 wipes per m2

                        30,5 cm × 30,5 cm wipe – 1 wipe per m2

                        45,7 cm × 45,7 cm wipe – 1 wipe per m2

                  Multi pack wipes:

                        30,5 cm × 30,5 cm – 1 wipe per m2

                  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

            See use-specific instructions for use.
            5.2.   Risk mitigation measures

            Use adequate ventilation with an air change rate of 8 per hour or more.
            Apply away from eyes and face.
            Hand protection: Wear chemically resistant protective gloves.
            Eye protection: Wear eye protection.
            Avoid contact with eyes.
            Do not breathe vapours.
            Do not eat, drink or smoke when using the product.
            Wash hands thoroughly after handling.
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            Symptoms/injuries after inhalation: May cause drowsiness or dizziness.
            Symptoms/injuries after skin contact: Repeated and/or prolonged skin contact may cause irritation, dryness or cracking.
            Symptoms/injuries after eye contact: Causes serious eye irritation.
            Symptoms/injuries after ingestion: Symptoms reported in humans are nausea and vomiting due to local irritation and systemic effects like drunkenness, drowsiness, sometimes unconsciousness and low blood sugar (especially in children). Because of the type of formulations (wipes, aerosol and spray) the systemic effects are however less likely.
            First-aid measures general: Never give anything orally to an unconscious person. If you feel unwell, seek medical advice (show the label if possible).
            IF INHALED: Move to fresh air and keep at rest in a position that is comfortable for breathing. Call a POISON CENTRE or a doctor.
            IF ON SKIN: Rinse skin with water/or shower. Remove all contaminated clothing immediately. Gently wash with plenty of soap and water. If symptoms develop, seek medical attention.
            IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor
            IF SWALLOWED: Rinse mouth. Give something to drink if conscious. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor.
            5.4.   Instructions for safe disposal of the product and its packaging

            Empty containers must be discharged as normal waste or recycled where possible.
            Additional information: Handle empty containers with care because residual vapours are flammable.
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

            Keep container tightly closed. Keep in a cool, well-ventilated place. Keep away from open flames, hot surfaces and sources of ignition. Store at temperatures below 30 °C.
            Shelf-life: 2 years
            6.   OTHER INFORMATION

            The product contains propan-2-ol (CAS No.: 67-63-0), for which a 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)

                        ALCOH-WIPE®
                        PROCESS2WIPE® IPA70

                        Market area: EU
                        Market area: EU

                        Authorisation number

                        EU-0024324-0001 1-1

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Propan-2-ol

                        Active Substance

                        67-63-0

                        200-661-7

                        65,4

               META SPC 2

            1.   META SPC 2 ADMINISTRATIVE INFORMATION

            1.1.   Meta SPC 2 identifier

                        Identifier

                        Meta SPC 2

                  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)

                  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

                        64,8

                        64,8

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

                        Formulation(s)

                        AE – Aerosol dispenser

                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

                        Hazard statements

                        Extremely flammable aerosol.
                        Pressurised container: May burst if heated.
                        Causes serious eye irritation.
                        May cause drowsiness or dizziness.
                        Repeated exposure may cause skin dryness or cracking.

                        Precautionary statements

                        Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
                        Do not spray on an open flame or other ignition source.
                        Do not pierce or burn, even after use.
                        Avoid breathing vapours.
                        Wash hands thoroughly after handling.
                        Wear protective gloves.
                        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 doctor if you feel unwell.
                        If eye irritation persists: Get medical advice.
                        Store in a well-ventilated place. Keep container tightly closed.
                        Store locked up.
                        Protect from sunlight. Do not expose at temperatures exceeding 50 °C/122 °F.
                        Dispose of contents in accordance with local/national regulations.
                        Wear eye protection.

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

            4.1.   Use description

               Table 2. Use # 1 – Disinfection of hard non-porous surfaces; Aerosols (propellant)

                        Product type

                        PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        -

                        Target organism(s) (including development stage)

                        Common name: Bacteria
                        Development stage: -
                        Common name: Yeast
                        Development stage: -

                        Field(s) of use

                        Indoor
                        Disinfectant for use in cleanrooms of pharmaceutical, biopharmaceutical, medical device and diagnostic product manufacturing facilities for the disinfection of hard non-porous inanimate surfaces, materials and equipment which are not used for direct contact with food or feeding stuffs.

                        Application method(s)

                        Aerosol spraying on surfaces

                        Application rate(s) and frequency

                        Maximal application 35 mL/m2 – RTU
                        Product may be used multiple times a day, if required.
                        Apply product by spraying from 15-20 cm distance for 20 seconds/m2.
                        Contact time: 2 min

                        Category(ies) of users

                        Industrial

                        Pack sizes and packaging material

                        325 mL (11 oz) – aerosol can (aluminium coated on the inside with epoxy phenolic resin)

                  4.1.1.   Use-specific instructions for use

            Clean and dry surfaces prior to disinfection. Spray the surface to be disinfected from a distance of 15-20 cm. Thoroughly wet surface with product for 20 seconds/m2, make sure to wet surfaces completely. Allow to take effect for at least 2 minutes. After the required contact time has been achieved, allow surface to air dry or wipe dry with sterilised cloth or wipe. Cloths or wipes treated with the product must be discarded in a closed container.
            4.1.2.   Use-specific risk mitigation measures

            Emergency eye wash fountains and safety showers should be available in the immediate vicinity of any potential exposure.
            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

            See use-specific instructions for use.
            5.2.   Risk mitigation measures

            Use adequate ventilation with an air change rate of 8 per hour or more.
            Apply away from eyes and face.
            Hand protection: Wear chemically resistant protective gloves.
            Eye protection: Wear eye protection.
            Avoid contact with eyes.
            Do not breathe vapours.
            Do not eat, drink or smoke when using the product.
            Wash hands thoroughly after handling.
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            Symptoms/injuries after inhalation: May cause drowsiness or dizziness.
            Symptoms/injuries after skin contact: Repeated and/or prolonged skin contact may cause irritation, dryness or cracking.
            Symptoms/injuries after eye contact: Causes serious eye irritation.
            Symptoms/injuries after ingestion: Symptoms reported in humans are nausea and vomiting due to local irritation and systemic effects like drunkenness, drowsiness, sometimes unconsciousness and low blood sugar (especially in children). Because of the type of formulations (wipes, aerosol and spray) the systemic effects are however less likely.
            First-aid measures general: Never give anything orally to an unconscious person. If you feel unwell, seek medical advice (show the label if possible).
            IF INHALED: Move to fresh air and keep at rest in a position that is comfortable for breathing. Call a POISON CENTRE or a doctor.
            IF ON SKIN: Rinse skin with water/or shower. Remove all contaminated clothing immediately. Gently wash with plenty of soap and water. If symptoms develop, seek medical attention.
            IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor
            IF SWALLOWED: Rinse mouth. Give something to drink if conscious. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor.
            5.4.   Instructions for safe disposal of the product and its packaging

            Empty containers must be discharged as normal waste or recycled where possible.
            Additional information: Handle empty containers with care because residual vapours are flammable.
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

            Keep away from open flames, hot surfaces and sources of ignition.
            Keep container tightly closed. Keep in a cool, well-ventilated place. Store at temperatures below 40 °C. Protect from frost.
            Shelf-life: 2 years
            6.   OTHER INFORMATION

            The product contains propan-2-ol (CAS No.: 67-63-0), for which a 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)

                        DEC-AHOL® AEROSOL WFI Formula

                        Market area: EU

                        Authorisation number

                        EU-0024324-0002 1-2

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Propan-2-ol

                        Active Substance

                        67-63-0

                        200-661-7

                        64,8

               META SPC 3

            1.   META SPC 3 ADMINISTRATIVE INFORMATION

            1.1.   Meta SPC 3 identifier

                        Identifier

                        Meta SPC 3

                  1.2.   Suffix to the authorisation number

                        Number

                        1-3

                  1.3.   Product type(s)

                        Product type(s)

                        PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

                  2.   META SPC 3 COMPOSITION

            2.1.   Qualitative and quantitative information on the composition of the meta SPC 3

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Min

                        Max

                        Propan-2-ol

                        Active Substance

                        67-63-0

                        200-661-7

                        65,4

                        65,4

                  2.2.   Type(s) of formulation of the meta SPC 3

                        Formulation(s)

                        AL – Any other liquid

                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3

                        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

                        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.
                        Wear protective gloves.
                        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 easy to do. Continue rinsing.
                        Call a doctor if you feel unwell.
                        If eye irritation persists: Get medical advice.
                        Store in a well-ventilated place. Keep cool.
                        Store locked up.
                        Dispose of contents in accordance with local/national regulations.
                        Avoid breathing spray.
                        Wear eye protection.

                  4.   AUTHORISED USE(S) OF THE META SPC 3

            4.1.   Use description

               Table 3. Use # 1 – Disinfection of hard non-porous surfaces; Trigger Spray, Liquid

                        Product type

                        PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        -

                        Target organism(s) (including development stage)

                        Common name: Bacteria
                        Development stage: -
                        Common name: Yeast
                        Development stage: -

                        Field(s) of use

                        Indoor
                        Disinfectant for use in cleanrooms of pharmaceutical, biopharmaceutical, medical device and diagnostic product manufacturing facilities for the disinfection of hard non-porous inanimate surfaces, materials and equipment which are not used for direct contact with food or feeding stuffs.

                        Application method(s)

                        Trigger Spraying on surfaces

                        Application rate(s) and frequency

                        Maximal application 35 mL/m2 – RTU
                        Product may be used multiple times a day, if required.
                        Apply product by spraying from 15-20 cm distance. Use 40 squeezes/m2.
                        Contact time: 2 min

                        Category(ies) of users

                        Industrial

                        Pack sizes and packaging material

                        Trigger:

                                    473 mL (16 oz) – trigger spray – 12/case, sterile

                                    946 mL (32 oz) – trigger spray – 12/case, sterile

                                    473 mL (16 oz) – trigger spray – 12/case, non-sterile

                                    946 mL (32 oz) – trigger spray – 12/case, non-sterile

                              Bottles are made of high density polyethylene, the dip tube is polypropylene. The bottle cap is polypropylene, the induction seal is polypropylene. Bottles are provided with a polyethylene sprayer already on the bottle or provided separately for customer to put on themselves. If the triggers are not installed, a polyethylene screw cap is supplied on the bottles. Bottles are individually triple bagged in cardboard boxes. The product is only supplied to the users in sealed cases.
                        Bag in bottle – Trigger:

                                    500 mL (16 oz) – Bag in bottle trigger spray – 12/case, sterile

                                    1000 mL (32 oz) – Bag in bottle trigger spray – 12/case, sterile

                              Bottles are made of high density polyethylene, they are provided with a polyethylene sprayer already on the bottle, the dip tube is polypropylene. The bag inside the bottle is Surlyn® (thermoplastic resins). Bottles are individually triple bagged in cardboard boxes. The product is only supplied to the users in sealed cases.

                  4.1.1.   Use-specific instructions for use

            Clean and dry surfaces prior to disinfection. Direct the spray onto the surface from a distance of 15-20cm. Make sure to wet the surface completely (40 squeezes/m2). Allow to take effect for at least 2 minutes. After the required contact time has been achieved, allow surface to air dry or wipe dry with sterilised cloth or wipe, if necessary. Only small surfaces may be disinfected. Cloths or wipes treated with the product must be discarded in a closed container.
            4.1.2.   Use-specific risk mitigation measures

            Emergency eye wash fountains and safety showers should be available in the immediate vicinity of any potential exposure.
            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.
            4.2.   Use description

               Table 4. Use # 2 – Disinfection of hard non-porous surfaces (including floors); Wiping

                        Product type

                        PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        -

                        Target organism(s) (including development stage)

                        Common name: Bacteria
                        Development stage: -
                        Common name: Yeast
                        Development stage: -

                        Field(s) of use

                        Indoor
                        Disinfectant for use in cleanrooms of pharmaceutical, biopharmaceutical, medical device and diagnostic product manufacturing facilities for the disinfection of hard non-porous inanimate surfaces, materials and equipment which are not used for direct contact with food or feeding stuffs.

                        Application method(s)

                        Wetting of sterile wipe/cloth prior to wiping of surface

                        Application rate(s) and frequency

                        Maximal application 35 mL/m2 – RTU
                        Product may be used multiple times a day, if required.
                        Contact time: 2 min

                        Category(ies) of users

                        Industrial

                        Pack sizes and packaging material

                        Squeeze bottle:

                                    473 mL (16 oz) – squeeze individually bagged- 12/case, sterile

                                    473 mL (16 oz) – squeeze, bulk group in one large bag – 12/case, sterile. Bulk pack bottles are not individually bagged.

                              Bottle is made of low density polyethylene
                        Drum or bottle:

                                    18,9 L (5 gallon drum) – container double bagged- 1/case, sterile

                                    3,79 L (1 gallon bottle) – each container double bagged- 4/case, sterile

                                    3,79 L (1 gallon bottle) – each container double bagged- 4/case, non-sterile

                  4.2.1.   Use-specific instructions for use

            Clean and dry surfaces prior to disinfection. Thoroughly wet a sterile wipe/cloth with the product, make sure to wet the surfaces completely. Allow to take effect for at least 2 minutes. After the required contact time has been achieved, allow surface to air dry or wipe dry with sterilised cloth or wipe, if necessary. Only small surfaces may be disinfected. Cloths or wipes treated with the product must be discarded in a closed container.
            4.2.2.   Use-specific risk mitigation measures

            Emergency eye wash fountains and safety showers should be available in the immediate vicinity of any potential exposure.
            4.2.3.   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.
            4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

            See general directions for use.
            4.2.5.   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.
            4.3.   Use description

               Table 5. Use # 3 – Disinfection of cleanroom gloves

                        Product type

                        PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        -

                        Target organism(s) (including development stage)

                        Common name: Bacteria
                        Development stage: -
                        Common name: Yeast
                        Development stage: -

                        Field(s) of use

                        Indoor
                        Disinfectant for use on gloved hands in cleanrooms of pharmaceutical, biopharmaceutical, medical device and diagnostic product manufacturing facilities.

                        Application method(s)

                        Dispensing of liquid droplets on gloves

                        Application rate(s) and frequency

                        1,5 mL per glove – RTU
                        Product may be used multiple times a day, if required.
                        Contact time: 1 min

                        Category(ies) of users

                        Industrial

                        Pack sizes and packaging material

                        946 mL (32 oz) bottle – 12/case, sterile
                        946 mL (32 oz) bottle – 12/case, non-sterile
                        The bottle is low density polyethylene

                  4.3.1.   Use-specific instructions for use

            Use product only in cleanrooms which are classified according to ISO 14644-1 in class 1 to 9 or according to GMP EU classification in grade A to D.
            Hold gloved hands under spout sensor to catch liquid. Thoroughly rub to distribute liquid evenly and wet clean glove surfaces with product. Do not wipe off and allow to remain wet for a minimum of 1 minute. After the required contact time has been achieved, allow surface to air dry or wipe dry with sterilised cloth or wipe, if necessary. Cloths or wipes treated with the product must be discarded in a closed container.
            Do not use on bare hands.
            4.3.2.   Use-specific risk mitigation measures

            Emergency eye wash fountains and safety showers should be available in the immediate vicinity of any potential exposure.
            4.3.3.   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.
            4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

            See general directions for use.
            4.3.5.   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 (3)
               OF THE META SPC 3

            5.1.   Instructions for use

            See use-specific instructions for use.
            5.2.   Risk mitigation measures

            Use adequate ventilation with an air change rate of 8 per hour or more.
            Apply away from eyes and face.
            Hand protection: Wear chemically resistant protective gloves.
            Eye protection: Wear eye protection.
            Avoid contact with eyes.
            Do not breathe vapours.
            Do not eat, drink or smoke when using the product.
            Wash hands thoroughly after handling.
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            Symptoms/injuries after inhalation: May cause drowsiness or dizziness.
            Symptoms/injuries after skin contact: Repeated and/or prolonged skin contact may cause irritation, dryness or cracking.
            Symptoms/injuries after eye contact: Causes serious eye irritation.
            Symptoms/injuries after ingestion: Symptoms reported in humans are nausea and vomiting due to local irritation and systemic effects like drunkenness, drowsiness, sometimes unconsciousness and low blood sugar (especially in children). Because of the type of formulations (wipes, aerosol and spray) the systemic effects are however less likely.
            First-aid measures general: Never give anything orally to an unconscious person. If you feel unwell, seek medical advice (show the label if possible).
            IF INHALED: Move to fresh air and keep at rest in a position that is comfortable for breathing. Call a POISON CENTRE or a doctor.
            IF ON SKIN: Rinse skin with water/shower. Remove all contaminated clothing immediately. Gently wash with plenty of soap and water. If symptoms develop, seek medical attention.
            IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor
            IF SWALLOWED: Rinse mouth. Give something to drink if conscious. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor.
            5.4.   Instructions for safe disposal of the product and its packaging

            Empty containers must be discharged as normal waste or recycled where possible.
            Additional information: Handle empty containers with care because residual vapours are flammable.
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

            Keep container tightly closed. Keep in a cool, well-ventilated place. Keep away from open flames, hot surfaces and sources of ignition. Store at temperatures below 40 °C.
            Protect from frost.
            Shelf-life: 2 years
            6.   OTHER INFORMATION

            The product contains propan-2-ol (CAS No.: 67-63-0), for which a 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 3

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

                        Trade name(s)

                        DEC-AHOL® WFI Formula
                        DEC-AHOL® ASEPTI-CLEANSE

                        Market area: EU
                        Market area: EU

                        Authorisation number

                        EU-0024324-0003 1-3

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Propan-2-ol

                        Active Substance

                        67-63-0

                        200-661-7

                        65,4

               META SPC 4

            1.   META SPC 4 ADMINISTRATIVE INFORMATION

            1.1.   Meta SPC 4 identifier

                        Identifier

                        Meta SPC 4

                  1.2.   Suffix to the authorisation number

                        Number

                        1-4

                  1.3.   Product type(s)

                        Product type(s)

                        PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

                  2.   META SPC 4 COMPOSITION

            2.1.   Qualitative and quantitative information on the composition of the meta SPC 4

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Min

                        Max

                        Propan-2-ol

                        Active Substance

                        67-63-0

                        200-661-7

                        65,4

                        65,4

                  2.2.   Type(s) of formulation of the meta SPC 4

                        Formulation(s)

                        AE – Aerosol dispenser

                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4

                        Hazard statements

                        Extremely flammable aerosol.
                        Pressurised container: May burst if heated.
                        Causes serious eye irritation.
                        May cause drowsiness or dizziness.
                        Repeated exposure may cause skin dryness or cracking.

                        Precautionary statements

                        Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
                        Do not spray on an open flame or other ignition source.
                        Do not pierce or burn, even after use.
                        Avoid breathing vapours.
                        Wash hands thoroughly after handling.
                        Wear protective gloves.
                        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 doctor if you feel unwell.
                        If eye irritation persists: Get medical advice.
                        Store in a well-ventilated place. Keep container tightly closed.
                        Store locked up.
                        Protect from sunlight. Do not expose at temperatures exceeding 50 °C/122 °F.
                        Dispose of contents in accordance with local/national regulations.
                        Wear eye protection.

                  4.   AUTHORISED USE(S) OF THE META SPC 4

            4.1.   Use description

               Table 6. Use # 1 – Disinfection of hard non-porous surfaces; Aerosols

                        Product type

                        PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        -

                        Target organism(s) (including development stage)

                        Common name: Bacteria
                        Development stage: -
                        Common name: Yeast
                        Development stage: -

                        Field(s) of use

                        Indoor
                        Disinfectant for use in cleanrooms of pharmaceutical, biopharmaceutical, medical device and diagnostic product manufacturing facilities for the disinfection of hard non-porous inanimate surfaces, materials and equipment which are not used for direct contact with food or feeding stuffs.

                        Application method(s)

                        Aerosol spraying on surfaces

                        Application rate(s) and frequency

                        Maximal application 35 mL/m2 – RTU
                        Product may be used multiple times a day, if required.
                        Apply product by spraying from 15-20 cm distance for 20 seconds/m2.
                        Contact time: 2 min

                        Category(ies) of users

                        Industrial

                        Pack sizes and packaging material

                        325 mL (11 oz) – Inverta-Spray® mist spray
                        Aluminium coated inside with epoxy phenolic resin fitted with low density polyethylene bag liner (bag-on-valve), compressed air propellant.

                  4.1.1.   Use-specific instructions for use

            Clean and dry surfaces prior to disinfection. Spray the surface to be disinfected from a distance of 15-20 cm. Thoroughly wet surface with product for 20 seconds/m2, make sure to wet surfaces completely. Allow to take effect for at least 2 minutes. After the required contact time has been achieved, allow surface to air dry or wipe dry with sterilised cloth or wipe. Cloths or wipes treated with the product must be discarded in a closed container.
            4.1.2.   Use-specific risk mitigation measures

            Emergency eye wash fountains and safety showers should be available in the immediate vicinity of any potential exposure.
            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 (4)
               OF THE META SPC 4

            5.1.   Instructions for use

            See use-specific instructions for use.
            5.2.   Risk mitigation measures

            Use adequate ventilation with an air change rate of 8 per hour or more.
            Apply away from eyes and face.
            Hand protection: Wear chemically resistant protective gloves.
            Eye protection: Wear eye protection.
            Avoid contact with eyes.
            Do not breathe vapours.
            Do not eat, drink or smoke when using the product.
            Wash hands thoroughly after handling.
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            Symptoms/injuries after inhalation: May cause drowsiness or dizziness.
            Symptoms/injuries after skin contact: Repeated and/or prolonged skin contact may cause irritation, dryness or cracking.
            Symptoms/injuries after eye contact: Causes serious eye irritation
            Symptoms/injuries after ingestion: Symptoms reported in humans are nausea and vomiting due to local irritation and systemic effects like drunkenness, drowsiness, sometimes unconsciousness and low blood sugar (especially in children). Because of the type of formulations (wipes, aerosol and spray) the systemic effects are however less likely.
            First-aid measures general: Never give anything orally to an unconscious person. If you feel unwell, seek medical advice (show the label if possible).
            IF INHALED: Move to fresh air and keep at rest in a position that is comfortable for breathing. Call a POISON CENTRE or a doctor.
            IF ON SKIN: Rinse skin with water/or shower. Remove all contaminated clothing immediately. Gently wash with plenty of soap and water. If symptoms develop, seek medical attention.
            IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor
            IF SWALLOWED: Rinse mouth. Give something to drink if conscious. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor.
            5.4.   Instructions for safe disposal of the product and its packaging

            Empty containers must be discharged as normal waste or recycled where possible.
            Additional information: Handle empty containers with care because residual vapours are flammable.
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

            Keep away from open flames, hot surfaces and sources of ignition.
            Keep container tightly closed. Keep in a cool, well-ventilated place. Store at temperatures below 40 °C.
            Protect from frost.
            Shelf-life: 2 years
            6.   OTHER INFORMATION

            The product contains propan-2-ol (CAS No.: 67-63-0), for which a 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 4

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

                        Trade name(s)

                        DEC-AHOL® AEROSOL WFI Formula Invertaspray

                        Market area: EU

                        Authorisation number

                        EU-0024324-0004 1-4

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Propan-2-ol

                        Active Substance

                        67-63-0

                        200-661-7

                        65,4

               (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.

               (3)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 3.

               (4)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 4.


title: Commission Implementing Regulation (EU) 2021/556 of 31 March 2021 amending Implementing Regulations (EU) 2017/1529 and (EU) No 540/2011 as regards the conditions of approval of the basic substance sodium chloride (Text with EEA relevance)

text:
                  6.4.2021

                  EN

                  Official Journal of the European Union

                  L 115/26

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/556
         of 31 March 2021
         amending Implementing Regulations (EU) 2017/1529 and (EU) No 540/2011 as regards the conditions of approval of the basic substance sodium chloride
         (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 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 13(2) in conjunction with Article 23(5) thereof,
         Whereas:

                     (1)

                     Commission Implementing Regulation (EU) 2017/1529 (2) approved the active substance sodium chloride as a basic substance and included it in Part C of the Annex to Commission Implementing Regulation (EU) No 540/2011 (3). The Commission based its decision on a Technical Report provided by the European Food Safety Authority (‘the Authority’) and a Review Report (4)established by the Commission.

                     (2)

                     The approval of the basic substance sodium chloride, as set out in Part C of the Annex to Implementing Regulation (EU) No 540/2011, was restricted to the use as fungicide and insecticide.

                     (3)

                     In November 2017, followed by an update in August 2018 and July 2020, the organisation Collectif Anti-baccharis submitted to the Commission an application in accordance with Article 23(3) of Regulation (EC) No 1107/2009 requesting the extension of use of sodium chloride as herbicide.

                     (4)

                     The Commission asked the European Food Safety Authority (‘the Authority’) for scientific assistance. The result of this consultation was that the nature of the substance and the extent of the request did not warrant a new scientific assessment by the Authority. The Commission prepared an updated review report, taking into account the earlier technical report of the Authority (5) and the information provided by the applicant.

                     (5)

                     The Commission presented the updated review report and the draft Regulation to the Standing Committee on Plants, Animals, Food and Feed on 25 January 2021.

                     (6)

                     The applicant was given the possibility to submit comments on the updated review report.

                     (7)

                     It appears that sodium chloride may be expected to satisfy the requirements laid down in Article 23 of Regulation (EC) No 1107/2009 with regard to the use as herbicide as detailed in the updated review report. Therefore, the use of sodium chloride as herbicide should be allowed. Moreover, given the fact that a new use of sodium chloride is being permitted, and that it is acceptable to continue allowing other possible uses of sodium chloride as referred to in the updated review report for sodium chloride, it is appropriate to withdraw the current restriction to use the substance as fungicide and insecticide only.

                     (8)

                     In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to maintain certain conditions for the use of the active substance.

                     (9)

                     Implementing Regulations (EU) 2017/1529 and (EU) No 540/2011 should therefore be amended accordingly.

                     (10)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            Amendment to Implementing Regulation (EU) 2017/1529
            Annex I to Implementing Regulation (EU) 2017/1529 is amended in accordance with Annex I to this Regulation.

            Article 2
            Amendment to Implementing Regulation (EU) No 540/2011
            The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.

            Article 3
            Entry into force
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 31 March 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1).

            (2)  Commission Implementing Regulation (EU) 2017/1529 of 7 September 2017 approving the basic substance sodium chloride in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ L 232, 8.9.2017, p. 1).

            (3)  Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).

            (4)  Final Review report for the basic substance sodium chloride finalised in the Standing Committee on Plants, Animals, Food and Feed at its meeting on 20 July 2017 and amended on 25 January 2021 in view of the approval of sodium chloride as basic substance in accordance with Regulation (EC) No 1107/2009; SANTE/10383/2017– rev.2.

            (5)  EFSA (European Food Safety Authority), 2017.Technical report on the outcome of the consultation with Member States and EFSA on the basic substance application for (sea) salt (sodium chloride) for use in plant protection as fungicide and insecticide. EFSA supporting publication 2017:EN-1172. 56pp.doi:10.2903/sp.efsa.2017.EN-1172.

            ANNEX I
            In Annex I to Implementing Regulation (EU) 2017/1529, the entry in the fifth column ‘Specific provisions’ is replaced by the following:

               ‘Sodium chloride shall be used in accordance with the specific conditions included in the conclusions of the review report on sodium chloride (SANTE/10383/2017) and in particular Appendices I and II thereof.’

            ANNEX II
            In Part C of the Annex to Implementing Regulation (EU) No 540/2011, the entry in the sixth column ‘Specific provisions’ of row number 16, sodium chloride, is replaced by the following:

               ‘Sodium chloride shall be used in accordance with the specific conditions included in the conclusions of the review report on sodium chloride (SANTE/10383/2017) and in particular Appendices I and II thereof.’


title: Council Implementing Regulation (EU) 2021/559 of 6 April 2021 implementing Article 12 of Regulation (EU) No 356/2010 imposing certain specific restrictive measures directed against certain natural or legal persons, entities or bodies, in view of the situation in Somalia

text:
                  6.4.2021

                  EN

                  Official Journal of the European Union

                  LI 115/1

         COUNCIL IMPLEMENTING REGULATION (EU) 2021/559
         of 6 April 2021
         implementing Article 12 of Regulation (EU) No 356/2010 imposing certain specific restrictive measures directed against certain natural or legal persons, entities or bodies, in view of the situation in Somalia
         THE COUNCIL OF THE EUROPEAN UNION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Regulation (EU) No 356/2010 of 26 April 2010 imposing certain specific restrictive measures directed against certain natural or legal persons, entities or bodies, in view of the situation in Somalia (1), and in particular Article 12 thereof,
         Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy,
         Whereas:

                     (1)

                     On 26 April 2010 the Council adopted Regulation (EU) No 356/2010.

                     (2)

                     On 26 February 2021 the United Nations Security Council (UNSC) Committee established pursuant to UNSC Resolution 751 (1992) approved the addition of three persons to the list of persons and entities subject to restrictive measures.

                     (3)

                     Annex I to Regulation (EU) No 356/2010 should therefore be amended accordingly,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Annex I to Regulation (EU) No 356/2010 is amended as set out in the Annex to this Regulation.

            Article 2
            This Regulation shall enter into force on the date 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, 6 April 2021.

                  For the Council

                  The President

               A. P. ZACARIAS

            (1)  OJ L 105, 27.4.2010, p. 1.

            ANNEX
            The persons listed below shall be added to the list set out in Annex I to Regulation (EU) No 356/2010:
            I.   Persons

                           ‘18.

                              Abukar Ali Adan (alias: a) Abukar Ali Aden; b) Ibrahim Afghan; c) Sheikh Abukar)

                              Designation: Deputy leader of Al-Shabaab

                              Date of Birth: a) 1972; b) 1971; c) 1973

                              Date of UN designation: 26 February 2021

                              Other information:
                           Listed pursuant to paragraph 8(a) of resolution 1844 (2008) as “Engaging in or providing support for acts that threaten the peace, security or stability of Somalia, including acts that threaten the Djibouti Agreement of 18 August 2008 or the political process, or threaten the TFIs or AMISOM by force.” Abukar Ali Adan is also associated with Al-Qaida affiliates, Al-Qaida in the Arabian Peninsula (AQAP – QDe.129) and Al-Qaida in the Islamic Maghreb (AQIM – Qde.014).

                           19.

                              Maalim Ayman (alias: a) Ma’alim Ayman; b) Mo’alim Ayman; c) Nuh Ibrahim Abdi; d) Ayman Kabo; e) Abdiaziz Dubow Ali)

                              Designation: Founder and leader of Jaysh Ayman, an al-Shabaab unit conducting attacks and operations in Kenya and Somalia

                              Date of Birth: a) 1973; b) 1983

                              Place of Birth: Kenya

                              Address: a) Kenya/Somalia border; b) Badamadow, Lower Juba Region, Somalia

                              Date of UN designation: 26 February 2021

                              Other information:

                           Listed pursuant to paragraph 8(a) of resolution 1844 (2008) as “Engaging in or providing support for acts that threaten the peace, security or stability of Somalia, including acts that threaten the Djibouti Agreement of 18 August 2008 or the political process, or threaten the TFIs or AMISOM by force.” Maalim Ayman helped with preparations for the 5 January 2020 attack on Camp Simba in Lamu County, Kenya.

                           20.

                              Mahad Karate (alias: a) Mahad Mohamed Ali Karate; b) Mahad Warsame Qalley Karate; c) Abdirahim Mohamed Warsame)

                              Date of Birth: Between 1957 and 1962

                              Place of Birth: Xararadheere, Somalia

                              Address: Somalia

                              Date of UN designation: 26 February 2021

                              Other information:

                           Listed pursuant to paragraph 8(a) of resolution 1844 (2008) as “Engaging in or providing support for acts that threaten the peace, security or stability of Somalia, including acts that threaten the Djibouti Agreement of 18 August 2008 or the political process, or threaten the TFIs or AMISOM by force.” Mahad Karate played a key role in the Amniyat, the wing of al-Shabaab responsible for the recent attack on Garissa University College in Kenya that resulted in nearly 150 deaths. The Amniyat is al-Shabaab’s intelligence wing, which plays a key role in the execution of suicide attacks and assassinations in Somalia, Kenya, and other countries in the region, and provides logistics and support for al-Shabaab’s terrorist activities.’