PAHs欧盟最新标准版62.docx

1、PAHs欧盟最新标准版62Product Safety Commission (AfPS) GS SpecificationTesting and assessment of polycyclic aromatic hydrocarbons (PAHs) in the course of awarding the GS mark- Specification pursuant to article 21(1) no. 3 of the Product Safety Act (ProdSG) AfPS GS 2021:01 PAKState of revision: August 4th, 20

2、21Disclaimer: German is the original text version. In case of any doubt, lack of clarity or any other non clear interpretation the content of the original version is valid.Management: Federal Institute for Occupational Safety and HealthFriedrich-Henkel-Weg 1 2544149 Dortmund Telefon: 0231/9071-0 Tel

3、efax: 0231/9071-2364Table of ContentsPreliminary observations 31Purpose / Intention 32Basics 33Procedure 33.1Risk assessment 33.2Categorisation 43.3Testing and assessment 64Transitional regulations/periods 64.1GS mark certificates, issued from July 1st, 2021 onwards 64.2GS mark certificates, issued

4、before July 1st, 2021 64.3Reissuing of existing GS mark certificates exemptions 6Annex: Testing instructions 81Aim and purpose 82Method 82.1Brief description 82.2Equipment 82.3Chemicals and solutions 83Preparation and execution 93.1Sample preparation 93.2Measuring procedure 103.3Special characterist

5、ics 11Annex: Measuring conditions for gas chromatography (for information) 12Testing and assessment of polycyclic aromatic hydrocarbons (PAHs) in the course of awarding the GS markPreliminary observationsOn Aug. 4th 2021 the Product Safety Commission (AfPS) has assigned the requirements of PAH testi

6、ng in the course of GS mark certification as specification according to art. 21 Product Safety Act (ProdSG) para. 1 no. 3. The implementation is achieved by means of this PAH document.1.Purpose / IntentionProducts (pursuant to the Product Safety Act) must comply with legal requirements to avoid heal

7、th risks, e.g. art. 30 & 31 of the LFBG (Foodstuffs, Consumer Goods and Feedstuffs Code LFGB), the Prohibition of Chemicals Ordinance, and the art. 3 of the ProdSG (Product Safety Act). This document and, in particular, the testing instructions (see Annex) specify the requirements with respect to th

8、e level of PAHs in products. In addition, the document harmonises the testing methodology for assessment by GS bodies.2.BasicsPAH contamination of materials is primarily due to the use of:-PAH contaminated softening oils in rubber and flexible (soft) plastics-PAH-contaminated carbon black as a black

9、 pigment in rubber, plastics and paints.PAH contamination has previously been detected not only in rubber but also in various types of plastic, e.g. ABS and PP, and various paints/coatings, as well as in a variety of natural materials.3.ProcedureThe GS body must take the following steps into account

10、 both in the process of awarding a new GS mark and within the framework of monitoring existing GS mark certificates:1.Risk assessment2.Categorisation3.Testing and assessment3.1Risk assessmentThe GS body must carry out a risk assessment and, in doing so, define which relevant contact/grip and operati

11、ng surfaces of the product are to be considered for testing and which are not, and must make a record of these (this means that the GS body must first specify the contact/grip and operating areas to which the requirements of the PAH document must be applied (specification of PAH relevance). The risk

12、 assessment should be not applied, where appropriate, if the respective “Erfahrungsaustauschkreis (“Exchange of Experience Group, EK) has already defined a procedure for the product or product group with regard to the contact/gripand operating surfaces to be tested. A reference to the EKs definition

13、 is to be included in the documentation accordingly.Materials that cannot be accessed or that can only be accessed by using tools need not be assessed, with the exception of samples with a conspicuous odour.In principle, account must be taken of all contact/grip and operating surfaces that can come

14、into direct contact with the skin or that can be put into the mouth during proper or foreseeable use (but not misuse).13.2CategorisationDepending on the results of the risk assessment, the corresponding product parts are then to be categorised (see Table 1) and to be analysed on their actual PAH con

15、tent according to the analysis method below. Existing test reports can be taken into account if they are compliant with the “Grundsatzbeschluss (“principle decision) ZEK-GB-2021-01 of the ZEK (“Central Exchange of Experience Group) and the requirements of this PAH document. Categorisation can be dis

16、pensed with if the respective Erfahrungsaustauschkreis (“Exchange of Experience Group, EK) has already defined a categorisation of the contact/grip and operating surfaces for a product or product group. Definitions for products or product groups from the individual EKs are published on the ZLS websi

17、te2 and apply from the time of publication.Table 1 presents the maximum levels of PAH in product materials, which must not be exceeded. The provisions of this document with regard to the PAH content do not apply if other legislation lays down corresponding or further requirements for the PAH content

18、. This applies only to the material or component/assembly and not to the product as a whole. Materials and parts of the product that are not covered by other legislative provisions must be assessed within the framework of the procedure for awarding the GS mark in accordance with the requirements of

19、the PAH document.It must be ensured that the method of testing can actually achieve the limit of quantification of0.2 mg/kg for each individual PAH component3.At the same time, method and matrix effects, as well as the measurement uncertainty, the efficiency of extraction and losses during purificat

20、ion must be considered. mg/kg.1However, in order to ensure a consistent and appropriate procedure during the awarding of GS mark, it is not generally necessary to analyse all freely accessible surfaces. It is this documents intention to limit the consideration to relevant contact/grip and operating

21、surfaces. It is not expedient to test all product parts or surfaces in order “to be on the safe side.2Homepage of ZLS (Central Authority of the Laender for Safety): 3Example: Water-carrying parts in coffee machines that come into contact with foodstuffs (e.g. water, etc.) are subject to the Food and

22、 Feed Code legislation and are therefore excluded from the PAH documents field of application. However, grip surfaces on the coffee machine must still be assessed according to the requirements of the PAH document.Table 1: Maximum PAH levels to be complied with for the materials in relevant contact/g

23、rip and operating surfaces that are to be categorised based on the results of the risk assessment.ParameterCategory 1Category 2Category 3Materials indented to be put in the mouth,or materials of toys with intended long- term skin contact (longer than 30 s)Materials not covered by category 1, with fo

24、reseeable skin contact for longer than 30 seconds (long-term skin contact) or repeatedshort-term skin contact1)Materials not covered by category 1 or 2 with foreseeable skin contact up to 30 seconds (short term skin contact)Toys in the scope of 2021/48/ECOther products in the scopeof ProdSGToys in t

25、he scope of 2021/48/ECOther products in the scopeof ProdSGBENZO(a)PYRENEmg/kg 1BENZO(e)PYRENE mg/kg 1BENZO(a)ANTHRACENEmg/kg 1BENZO(b)FLUORANTHENEmg/kg 1BENZO(j)FLUORANTHENEmg/kg 1BENZO(k)FLUORANTHENEmg/kg 1CHRYSENE mg/kg 1DIBENZO(a,h)ANTHRACENE mg/kg 1BENZO(g,h,i)PERYLENEmg/kg 1INDENO(l,2,3-cd)PYRE

26、NEmg/kg 1ACENAPHTHYLENE, ACENAPHTHENE, FLUORENE, PHENANTHRENE, PYRENE, ANTHRACENE, FLUORANTHENEmg/kg1sum 5sum 10sum 20sum 50sumNAPHTHALENEmg/kg 1 2 10Sum 18 PAH 3 mg/kg 1 5 10 20 50* Wording “short-term repetitive skin contact from supplement to REACH annex XVII no. 50 (REGULATION (EU) No 1272/2021)

27、3.3 Testing and assessmentThe testing instructions found in the annex describe the steps of sample preparation, extraction of the PAHs, purification of the extract, identification and quantification; these must be applied uniformly by all laboratories carrying out testing.The GS body assesses the te

28、st results and decides whether the GS mark can be awarded in compliance with the other requirements.4.Transitional regulations/periodsFrom July 1st 2021 (issue date of the GS mark certificate), it is compulsory to apply this document when awarding the GS mark to products.The document ZEK 01.4-08 wil

29、l cease to be valid from June 30th 2021.Since testing for PAH levels in products constitutes an overarching requirement for almost all of the members of all of the Erfahrungsaustauschkreise (“Exchange of Experience Groups), the following procedure is defined:4.1GS mark certificates, issued from July

30、 1st 2021 onwards(incl. ongoing procedures that are concluded after July 1st 2021)Compulsory application of this GS specification from July 1st 2021 onwards (exception: see 4.3).4.2GS mark certificates, issued before July 1st 2021Existing GS mark certificates initially remain valid.Within the framew

31、ork of regular checks to monitor the manufacturing process (at the latest within one year or, in cases where the regular monitoring period is two years, within two years), the requirements under no. 3 of the ZEK (“Central Exchange of Experience Group) document with regard to the risk assessment must be taken into account, regardless of whether the product was found in the manufacturing facility or not. If, in the process, it is found that the corresponding requirements are not met, the GS mark certificate must be withdrawn i