Final report ANNEXES

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Final report ANNEXES

CASP Corona2020

Coordinated Activities on the Safety of Products

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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

Slovenia Market Inspectorate Face mask FM_SI_4

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

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

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

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

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

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

France

Directorate General for Competition, Consumer Affairs and Fraud Prevention

(DGCCRF) Face mask FM_FR_50

France

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

France

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

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

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

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

Hand cleaners &

disinfectants HC&D_DE_23 Germany Bavarian State Ministry of the

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

Hand cleaners &

disinfectants HC&D_DE_31 Germany

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

disinfectants HC&D_PT_34 Portugal ASAE - Economic and Food Safety

disinfectants HC&D_PT_35 Romania National Authority for Consumer

Protection

Hand cleaners &

disinfectants HC&D_RO_36 Portugal ASAE - Economic and Food Safety

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

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

Protection Gloves G_RO_19

Authority Gloves G_PT_20

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

Final report ANNEXES