CELEX: 32019R2076
Language: en
Date: 2019-11-29 00:00:00
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)

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.