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Testing 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 2023:01 PAK
State of revision: August 4th, 2023
Disclaimer: 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 Health
Friedrich-Henkel-Weg 1 – 25
44149 Dortmund Telefon: 0231/9071-0 Telefax: 0231/9071-2364
Table of Contents
Preliminary observations 3
Purpose / Intention 3
Basics 3
Procedure 3
Risk assessment 3
Categorisation 4
Testing and assessment 6
Transitional regulations/periods 6
GS mark certificates, issued from July 1st, 2015 onwards 6
GS mark certificates, issued before July 1st, 2015 6
Reissuing of existing GS mark certificates – exemptions 6
Annex: Testing instructions 8
Aim and purpose 8
Method 8
Brief description 8
Equipment 8
Chemicals and solutions 8
Preparation and execution 9
Sample preparation 9
Measuring procedure 10
Special characteristics 11
Annex: Measuring conditions for gas chromatography (for information) 12
Testing and assessment of polycyclic aromatic hydrocarbons (PAHs) in the course of awarding the GS mark
Preliminary observations
On Aug. 4th 2023 the Product Safety Commission (AfPS) has assigned the requirements of PAH testing 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.
Purpose / Intention
Products (pursuant to the Product Safety Act) must comply with legal requirements to avoid health risks, . 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 the level of PAHs in products. In addition, the document harmonises the testing methodology for assessment by GS bodies.
Basics
PAH 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 pigment in rubber, plastics and paints.
PAH contamination has previously been detected not only in rubber but also in various types of plastic, . ABS and PP, and various paints/coatings, as well as in a variety of natural materials.
Procedure
The GS body must take the following steps into account both in the process of awarding a new GS mark and within the framework of monitoring existing GS mark certificates:
Risk assessment
Categorisation
Testing and assessment
Risk assessment
The GS body must carry out a risk assessment and, in doing so, define which relevant contact/grip and operating 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 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/grip
and operating surfaces to be tested. A reference to the EK’s definition 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 into direct contact with the skin or that can be put into the mouth during proper or foreseeable use (but not misuse).1
Categorisation
Depending 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 content 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-2023-01 of the ZEK (“Central Exchange of Experience Group”) and the requirements of this PAH document. Categorisation can be dispensed 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 website2 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. 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 the PAH document.
It must be ensured that the method of testing can actually achieve the limit of quantification of
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 purification must be considered.
Based on the findings of the United States Environmental Protection Agency (EPA) (according to the list in the ZEK document 04-11), the total of 18 PAHs (extended substance list of the AtAV, the predecessor committee of the AfPS) only considers PAH components whose level in the material is found to exceed mg/kg.
However, 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 document’s intention to limit the consideration to relevant contact/grip and operating surfaces. It is not expedient to test all product parts or surfaces in order “to be on the safe side”.
Homepage of ZLS (Central Authority of the Laender for Safety):
Example: Water-carrying parts in coffee machines that come into contact with foodstuffs (. water, etc.) are subject to the Food and Feed Code legislation and are therefore excluded from the PAH document’s 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/grip and operating surfaces that are to be categorised based on the results of the risk assessment.
Parameter
Category 1
Category 2
Category 3
Materials 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 foreseeable skin contact for longer than 30 seconds (long-term skin contact) or repeated
short-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 2023/48/EC
Other products in the scope
of ProdSG
Toys in the scope of 2023/48/EC
Other products in the scope
of ProdSG
BENZO(a)PYRENE
mg/kg
<
<
<
<
< 1
BENZO(e)PYREN
E mg/kg
<
<
<
<
< 1
BENZO(a)ANTHRACENE
mg/kg
<
<
<
<
< 1
BENZO(b)FLUORANTHENE
mg/kg
<
<
<
<
< 1
BENZO(j)FLUORANTHENE
mg/kg
<
<
<
<
< 1
BENZO(k)FLUORANTHENE
mg/kg
<
<
<
<
< 1
CHRYSEN
E mg/kg
<
<
<
<
< 1
DIBENZO(a,h)ANTHRACEN
E mg/kg
<
<
<
<
< 1
BENZO(g,h,i)PERYLENE
mg/kg
<
<
<
<
< 1
INDENO(l,2,3-cd)PYRENE
mg/kg
<
<
<
<
< 1
ACENAPHTHYLENE, ACENAPHTHENE, FLUORENE, PHENANTHRENE, PYRENE, ANTHRACENE, FLUORANTHENE
mg/kg
<1
sum
< 5
sum
< 10
sum
< 20
sum
< 50
sum
NAPHTHALENE
mg/kg
< 1
< 2
< 10
Sum 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 1272/2023)
Testing and assessment
The 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 test results and decides whether the GS mark can be awarded in compliance with the other requirements.
Transitional regulations/periods
From July 1st 2023 (issue date of the GS mark certificate), it is compulsory to apply this document when awarding the GS mark to products.
The document ZEK -08 will cease to be valid from June 30th 2023.
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:
GS mark certificates, issued from July 1st 2023 onwards
(incl. ongoing procedures that are concluded after July 1st 2023)
Compulsory application of this GS specification from July 1st 2023 onwards (exception: see ).
GS mark certificates, issued before July 1st 2023
Existing GS mark certificates initially remain valid.
Within the framework 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 immediately. The ZEK ”Grundsatzbeschluss” (“principle decision”) ZEK-GB-2023-01 must be complied with.
Reissuing of existing GS mark certificates – exemptions
For the reissuing of an existing GS mark certificate, immediate consideration is not required in the following circumstances:
If the company name is changed, new GS mark certificates are usually issued. However, since the product does not change in terms of construction or other properties, and the reissuing of the GS mark certificate is more or less a pure formality, it is not necessary to consider the requirements of the PAH decision until the time of the check which must be performed for the purposes of monitoring the manufacturing process.
(Please note: The reissuing of the GS mark certificate does not alter the previously defined periods for carrying out checks on the product’s manufacturing process.)
The same applies by analogy when the holder of the GS mark certificate changes address provided none of the product’s properties change and the product does not require an additional safety check.
The above procedure can also be applied in relation to duplicate certificates (also referred to as OEM certificates). In such cases, a review pursuant to the requirements of the PAH document must strictly be carried out by the time of the next product-manufacturing check according to the periods already defined in the “main certificate” or, at the latest, by December 28th 2023.
Monitoring intervals beyond this date are not permiss