CASP Corona2020

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Final report ANNEXES CASP Corona2020 Coordinated Activities on the Safety of Products Justice and Consumers

Transcript of CASP Corona2020

Page 1: CASP Corona2020

Final report

ANNEXES

CASP Corona2020 Coordinated Activities on the Safety of Products

Justice and Consumers

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Table of Contents

ANNEX 1 - TESTING PLAN ........................................................................................................................ 3

ANNEX 2 - OVERVIEW OF TESTED SAMPLES ........................................................................................... 5

ANNEX 3 - SAMPLING CODIFICATION TABLE ........................................................................................ 12

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ANNEX 1 - TESTING PLAN

The set criteria were developed, harmonised and agreed by all participating MSAs and the technical

experts. After sampling process, the products were tested in a single accredited laboratory.

Three product groups (PPE face masks, hand cleaners and disinfectants, and PPE single-use gloves)

were tested according to the testing plan specified in the technical specifications.

Testing was carried out using clauses of the appropriate regulations/ standards, concerning the set

criteria.

• PPE Face masks

Aspect cover* Standard/Regulation Section Labelling Reg (EU) 2016/425 -

Total inward leakage EN 149:2001+A1:2009 Section 8.5

Penetration of filter material EN 149:2001+A1:2009 EN 13274-7:2019

Section 8.11

* As per CASP Corona2020 Technical specifications

• Hand cleaners and disinfectants

Aspect cover* Standard/Regulation/Method Details Labelling Reg (EU) 528/2012

Reg (EC) 1272/2008 -

Density Annex to Directive 92/69/EEC -

Densities of high/low viscosity

ISO 12185:1996 ISO 15212-1:1998

-

Concentration of the active substances as indicated by the IFU/labelling of the manufacturer

Chemistry 10th ed. (Chang, R., 2010.Chemistry. 10th ed. Boston: McGraw-Hill, pp.156 -159)

Hypochlorous acid Sodium hypochlorite

EN 15721:2013 Ethanol 2-propanol 1-propanol

US Pharmacopeia Chlorhexidine digluconate

GC-FID 2-Phenoxyethanol

LC-MS/MS Quaternary ammonium compounds (e.g. didecyldimethylammonium chloride (DDAC C8-C10), N-Decyl-N, N-dimethyl-1-decanaminium chloride (DDAC), benzalkonium chloride (BAC, C8-C18), alkyl(ethylbenzyl)di-

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methylammonium chloride (EtBAC, C12-C14), C12-18-alkyldimethylbenzyl ammonium chloride, C12-C14 N-alkyl-N,N-dimethyl-N-benzylammonium chloride, N,N-dialkyl(C8-10)-N,N-dimethylammonium chloride)

* As per CASP Corona2020 Technical specifications

• Gloves

Aspect cover* Standard/Regulation Section

Labelling EN 420:2003+A1:2009 Reg (EU) 2016/425

Section 7.2 and 7.3

Resistance of Glove Materials to Water Penetration

EN 420:2003+A1:2009 EN 455-1:2020

Section 4.2

Innocuousness of protective gloves

EN 420:2003+A1:2009 EN 1413:1998 EN 455-3

Section 4.3

Shelf life EN 420:2003+A1:2009 Section 7.2

Information supplied by the manufacturer

EN 420:2003+A1:2009 Section 7.3

Permeation of chemicals EN ISO 374-1:2016 EN 16523-1:2015

Section 5.4

Penetration EN ISO 374-5:2016 EN 374-2:2014

Section 5.2

Protection against viruses EN ISO 374-5:2016 ISO 16604:2004

Section 5.2

* As per CASP Corona2020 Technical specifications.

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ANNEX 2 - OVERVIEW OF TESTED SAMPLES

Legend Met the requirements

Did not meet the requirements

Country Name of sampling MSA Product type Unique

identifier Test

results

Czechia Czech Trade Inspection Authority Face mask FM_CZ_1

Czechia Czech Trade Inspection Authority Face mask FM_CZ_2

Czechia Czech Trade Inspection Authority Face mask FM_CZ_3

Slovenia Market Inspectorate Face mask FM_SI_4

Slovenia Market Inspectorate Face mask FM_SI_5

Germany District government Arnsberg Face mask FM_DE_6

Germany District government Arnsberg Face mask FM_DE_7

Malta Malta Competition and Consumer Affairs Authority

Face mask FM_MT_8

Malta Malta Competition and Consumer Affairs Authority

Face mask FM_MT_9

Malta Malta Competition and Consumer Affairs Authority

Face mask FM_MT_10

Slovenia Market Inspectorate Face mask FM_SI_11

Germany District government Arnsberg Face mask FM_DE_12

Slovakia Slovak Trade Inspection Face mask FM_SK_13

Estonia Consumer Protection and Technical Regulatory Authority

Face mask FM_EE_14

Estonia Consumer Protection and Technical Regulatory Authority

Face mask FM_EE_15

Estonia Consumer Protection and Technical Regulatory Authority

Face mask FM_EE_16

Spain Spanish Ministry for Consumer Affairs Face mask FM_ES_17

Slovakia Slovak Trade Inspection Face mask FM_SK_18

Cyprus Department of Labour Inspection Face mask FM_CY_19

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Country Name of sampling MSA Product type Unique

identifier Test

results

Cyprus Department of Labour Inspection Face mask FM_CY_20

Iceland Consumer agency Face mask FM_IS_21

Iceland Consumer agency Face mask FM_IS_22

Iceland Consumer agency Face mask FM_IS_23

Spain Spanish Ministry for Consumer Affairs Face mask FM_ES_24

Latvia Consumer Rights Protection Centre Face mask FM_LV_25

Latvia Consumer Rights Protection Centre Face mask FM_LV_26

Latvia Consumer Rights Protection Centre Face mask FM_LV_27

Croatia State Inspectorate, Market Surveillance Face mask FM_HR_28

Croatia State Inspectorate, Market Surveillance Face mask FM_HR_29

Croatia State Inspectorate, Market Surveillance Face mask FM_HR_30

Germany Gewerbeaufsicht des Landes Bremen Face mask FM_DE_31

Germany Gewerbeaufsicht des Landes Bremen Face mask FM_DE_32

Germany Gewerbeaufsicht des Landes Bremen Face mask FM_DE_33

Slovakia Slovak Trade Inspection Face mask FM_SK_34

Spain Spanish Ministry for Consumer Affairs Face mask FM_ES_35

Cyprus Department of Labour Inspection Face mask FM_CY_36

Lithuania State Consumer Rights Protection Authority

Face mask FM_LT_37

Lithuania State Consumer Rights Protection Authority

Face mask FM_LT_38

Lithuania State Consumer Rights Protection Authority

Face mask FM_LT_39

Finland Finnish Safety and Chemicals Agency (Tukes)

Face mask FM_FI_40

Ireland Competition and Consumer Protection Commission

Face mask FM_IE_41

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Country Name of sampling MSA Product type Unique

identifier Test

results

Ireland Competition and Consumer Protection Commission

Face mask FM_IE_42

Ireland Competition and Consumer Protection Commission

Face mask FM_IE_43

Hungary Ministry for Innovation and Technology Face mask FM_HU_44

Hungary Ministry for Innovation and Technology Face mask FM_HU_45

Hungary Ministry for Innovation and Technology Face mask FM_HU_46

Luxembourg ILNAS Face mask FM_LU_47

Luxembourg ILNAS Face mask FM_LU_48

Luxembourg ILNAS Face mask FM_LU_49

France Directorate General for Competition, Consumer Affairs and Fraud Prevention (DGCCRF)

Face mask FM_FR_50

France Directorate General for Competition, Consumer Affairs and Fraud Prevention (DGCCRF)

Face mask FM_FR_51

Germany District government Düsseldorf Face mask FM_DE_52

Romania National Authority for Consumer Protection

Face mask FM_RO_53

Romania National Authority for Consumer Protection

Face mask FM_RO_54

France Directorate General for Competition,

Consumer Affairs and Fraud Prevention (DGCCRF)

Face mask FM_FR_55

Germany District government Düsseldorf Face mask FM_DE_56

Germany District government Düsseldorf Face mask FM_DE_57

Portugal ASAE - Economic and Food Safety Authority Face mask FM_PT_58

Portugal ASAE - Economic and Food Safety Authority Face mask FM_PT_59

Portugal ASAE - Economic and Food Safety Authority Face mask FM_PT_60

Belgium Federal Public Service Economy - Directorate general Quality and Safety

Face mask FM_BE_61

Belgium Federal Public Service Economy - Directorate general Quality and Safety

Face mask FM_BE_62

Belgium Federal Public Service Economy - Directorate general Quality and Safety

Face mask FM_BE_63

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Country Name of sampling MSA Product type Unique

identifier Test

results

Iceland Administration of Occupational Safety and Health

Face mask FM_IS_64

Iceland Administration of Occupational Safety and Health

Face mask FM_IS_65

Iceland Administration of Occupational Safety and Health

Face mask FM_IS_66

Romania National Authority for Consumer Protection

Face mask FM_RO_67

Finland Finnish Safety and Chemicals Agency (Tukes)

Face mask FM_FI_68

Finland Finnish Safety and Chemicals Agency (Tukes)

Face mask FM_FI_69

Denmark Danish Safety Technology Authority Face mask FM_DK_70

Denmark Danish Safety Technology Authority Face mask FM_DK_71

Denmark Danish Safety Technology Authority Face mask FM_DK_72

Ireland Competition and Consumer Protection Commission

Face mask FM_IE_73

Ireland Competition and Consumer Protection Commission

Face mask FM_IE_75

Croatia State Inspectorate, Sanitary Inspection Hand cleaners &

disinfectants HC&D_HR_1

Croatia State Inspectorate, Sanitary Inspection Hand cleaners &

disinfectants HC&D_HR_2

Croatia State Inspectorate, Sanitary Inspection Hand cleaners &

disinfectants HC&D_HR_3

Malta Malta Competition and Consumer Affairs Authority

Hand cleaners & disinfectants

HC&D_MT_4

Malta Malta Competition and Consumer Affairs Authority

Hand cleaners & disinfectants

HC&D_MT_5

Malta Malta Competition and Consumer Affairs Authority

Hand cleaners & disinfectants

HC&D_MT_6

Luxembourg Environmental Administration Hand cleaners &

disinfectants HC&D_LU_7

Luxembourg Environmental Administration Hand cleaners &

disinfectants HC&D_LU_8

Luxembourg Environmental Administration Hand cleaners &

disinfectants HC&D_LU_9

Iceland The Environment Agency of Iceland Hand cleaners &

disinfectants HC&D_IS_10

Iceland The Environment Agency of Iceland Hand cleaners &

disinfectants HC&D_IS_11

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Country Name of sampling MSA Product type Unique

identifier Test

results

Iceland The Environment Agency of Iceland Hand cleaners &

disinfectants HC&D_IS_12

Sweden Swedish Chemicals Agency Hand cleaners &

disinfectants HC&D_SE_13

Sweden Swedish Chemicals Agency Hand cleaners &

disinfectants HC&D_SE_14

Sweden Swedish Chemicals Agency Hand cleaners &

disinfectants HC&D_SE_15

Finland Finnish Safety and Chemicals Agency (Tukes)

Hand cleaners & disinfectants

HC&D_FI_16

Finland Finnish Safety and Chemicals Agency (Tukes)

Hand cleaners & disinfectants

HC&D_FI_17

Finland Finnish Safety and Chemicals Agency (Tukes)

Hand cleaners & disinfectants

HC&D_FI_18

Lithuania State Consumer Rights Protection Authority

Hand cleaners & disinfectants

HC&D_LT_19

Lithuania State Consumer Rights Protection Authority

Hand cleaners & disinfectants

HC&D_LT_20

Lithuania State Consumer Rights Protection Authority

Hand cleaners & disinfectants

HC&D_LT_21

Germany Bavarian State Ministry of the Environment and Consumer Protection

Hand cleaners & disinfectants

HC&D_DE_22

Germany Bavarian State Ministry of the Environment and Consumer Protection

Hand cleaners & disinfectants

HC&D_DE_23

Germany Bavarian State Ministry of the Environment and Consumer Protection

Hand cleaners & disinfectants

HC&D_DE_24

Romania National Authority for Consumer Protection

Hand cleaners & disinfectants

HC&D_RO_25

Romania National Authority for Consumer Protection

Hand cleaners & disinfectants

HC&D_RO_26

Spain Spanish Agency for Medicines and Medical Devices

Hand cleaners & disinfectants

HC&D_ES_27

Spain Spanish Agency for Medicines and Medical Devices

Hand cleaners & disinfectants

HC&D_ES_28

Spain Spanish Agency for Medicines and Medical Devices

Hand cleaners & disinfectants

HC&D_ES_29

Germany State Office for Occupational Safety,

Consumer Protection and Health (LAVG)

Hand cleaners & disinfectants

HC&D_DE_30

Germany State Office for Occupational Safety, Consumer Protection and Health (LAVG)

Hand cleaners & disinfectants

HC&D_DE_31

Germany State Office for Occupational Safety, Consumer Protection and Health (LAVG)

Hand cleaners & disinfectants

HC&D_DE_32

Portugal ASAE - Economic and Food Safety Authority

Hand cleaners & disinfectants

HC&D_PT_33

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Country Name of sampling MSA Product type Unique

identifier Test

results

Portugal ASAE - Economic and Food Safety

Authority Hand cleaners &

disinfectants HC&D_PT_34

Portugal ASAE - Economic and Food Safety Authority

Hand cleaners & disinfectants

HC&D_PT_35

Romania National Authority for Consumer Protection

Hand cleaners & disinfectants

HC&D_RO_36

Portugal ASAE - Economic and Food Safety

Authority Hand cleaners &

disinfectants HC&D_PT_37

Portugal ASAE - Economic and Food Safety Authority

Hand cleaners & disinfectants

HC&D_PT_38

Portugal ASAE - Economic and Food Safety Authority

Hand cleaners & disinfectants

HC&D_PT_39

Cyprus Department of Labour Inspection Gloves G_CY_1

Cyprus Department of Labour Inspection Gloves G_CY_2

Latvia Consumer Rights Protection Centre Gloves G_LV_3

Latvia Consumer Rights Protection Centre Gloves G_LV_4

Latvia Consumer Rights Protection Centre Gloves G_LV_5

Cyprus Department of Labour Inspection Gloves G_CY_6

Lithuania State Consumer Rights Protection Authority

Gloves G_LT_7

Lithuania State Consumer Rights Protection Authority

Gloves G_LT_8

Lithuania State Consumer Rights Protection Authority

Gloves G_LT_9

Germany District government Arnsberg Gloves G_DE_10

Germany District government Arnsberg Gloves G_DE_11

Germany District government Arnsberg Gloves G_DE_12

Croatia State Inspectorate, Market Surveillance Gloves G_HR_13

Croatia State Inspectorate, Market Surveillance Gloves G_HR_14

Croatia State Inspectorate, Market Surveillance Gloves G_HR_15

Luxembourg ILNAS Gloves G_LU_16

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Country Name of sampling MSA Product type Unique

identifier Test

results

Luxembourg ILNAS Gloves G_LU_17

Luxembourg ILNAS Gloves G_LU_18

Romania National Authority for Consumer Protection

Gloves G_RO_19

Portugal ASAE - Economic and Food Safety

Authority Gloves G_PT_20

Portugal ASAE - Economic and Food Safety Authority Gloves G_PT_21

Portugal ASAE - Economic and Food Safety Authority Gloves G_PT_22

Belgium Federal Public Service Economy - Directorate general Quality and Safety

Gloves G_BE_23

Belgium Federal Public Service Economy - Directorate general Quality and Safety

Gloves G_BE_24

Belgium Federal Public Service Economy - Directorate general Quality and Safety

Gloves G_BE_25

Romania National Authority for Consumer Protection

Gloves G_RO_26

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ANNEX 3 - SAMPLING CODIFICATION TABLE

General point Details

Sample number

Unique identifier (Product abbr/Sampling Country abbr/Sample Number)

Date when sample was sent to the lab

Date when sample was received at the lab for testing

Sampling details • Sampling date (DD/MM/YYYY) • Full name of sampling MSA • Country of sampling MSA • Number of specimens kept at MSA (as

contra-proof/witness) • Information on storage of the specimen

kept as contra-proof/witness • Price/specimen in local currency • Local currency • Price/specimen in EUR • MSA unique identifier

Product identification • Product name (on the product or packaging)

• Brand name • Product type/model • Product and packaging description • EAN code • Specimen Global Trade Item Number

(GTIN) • Specimen Manufacturer Part Numbers

(MPN)

Product Traceability • Retail channel • Retailer / Name • Retailer / Address or Website • Distributor / name • Distributor country • Importer name • Importer country • Exporter name • Exporter country • Manufacturer name • Manufacturer country

Additional information • Comments • Picture