Quality assurance and test specifications of the Gütegemeinschaft Mineralwolle e.V. for products made of mineral wool

Version: July 2017

  1. Scope of the quality assurance and test specifications
  2. Quality assurance and test specifications
  3. Monitoring
  4. Labelling
  5. Amendments
  6. Annex

1. Scope of the quality assurance and test specifications

1.1 These quality assurance and test specifications apply to the manufacture of products made of mineral wool. They do not apply to other contact with products made of mineral wool. 

Mineral wool within the meaning of this quality assurance is glass, rock or slag wool made of man-made, randomly distributed, vitreous (silicate) fibres with an alkali and alkaline- earth metal oxides (Na2O + K2O + CaO + MgO + BaO) content of more than 18 percent by weight. 

1.2 The requirements listed in the respectively applicable technical regulations of the Construction Products List B, part 1, section 1, shall be met for the use of products made of mineral wool as regulated construction products in Germany. 

1.3 The requirements of the respective approvals shall be met for the use of products made of mineral wool as unregulated construction products in Germany. 

1.4 The requirements of DIN 4140, referenced standards and guidelines and the quality requirements of any approvals shall be met for the use of products made of mineral wool for "technical insulation" in Germany. 

1.5 The requirements of DIN EN 13162 for the use as insulation material in buildings shall be met by products made of mineral wool. 

1.6 The requirements of DIN EN 14064-1 and DIN EN 14064-2 for the use as insulation material finished on construction site shall be met by products made of mineral wool. 

1.7 The requirements of DIN EN 14303 for the use as insulation material for technical equipment in buildings and in industrial plants shall be met by products of mineral wool. 

1.8 The requirements of the appropriate directives of the European Union or the International Maritime Organisation (IMO) shall be met for the use of products made of mineral wool in "shipbuilding". 

1.9 The respective country-specific requirements and labels shall be met for the use of products made of mineral wool outside Germany. 

1.10 Should a manufacturer of the construction products named in section 1.2 subject these products to requirements that constitute a tightening of the requirements named in section 1.2 and displays this on the label in the packaging, these tightened requirements must be met if they are the subject of monitoring conforming to standard. These regulations apply accordingly to sections 1.3 to 1.9. 

1.11 The Gütegemeinschaft Mineralwolle e.V. awards the RAL quality mark to manufacturers of products made of mineral wool if they fulfil the current requirements of sections 1.2 to 1.10.

 

2 Quality assurance and test specifications 

To achieve the RAL quality mark, the additional requirements named in sections 2.1 and 2.2 are applied and tested as part of the quality assurance process. 

2.1 Verification of approval
Verification of approval of a type of mineral wool fibre can be provided by passing cumulatively both one of the test procedure named in section 2.1.2 (intratracheal test) and one of the three test procedures named in sections 2.1.4 to 2.1.6 (intratracheal test, short-term inhalation test, long-term Inhalation test). The test procedure of section 2.1.3 (determination of the carcinogenicity index) may complete the verification of approval of section 2.1.2.The verification of approval can instead also be provided by passing the test procedure named in section 2.1.1 (intraperitoneal test). In the case of a verification of approval, the following prohibitions do not apply to products made of mineral wool:
- ban on manufacturing and use in accordance with Annex II no. 5 of the GefStoffV [Ordinance on Hazardous Substances]
- ban on placing on the market in accordance with Annex 1 to § 3 of the ChemVerbotsV [Chemicals Ban Ordinance] 

2.1.1 Intraperitoneal test (i.p. test)
A suitable intraperitoneal test has not shown any signs of excessive carcinogenicity.
Suitable tests carried out by qualified institutes such as the Fraunhofer-Institut für ToxikoIogie und Experimentelle Medizin (ITEM) are recognised. All documents for the relevant test shall be submitted with the application. 

2.1.2 Intratracheal test (half-life of the WHO fibres)
The half-life after intratracheal instillation of 2 mg of a fibre suspension of fibres with a length greater than 5 µm, a diameter less than 3 µm and length-to-diameter ratio of greater than 3:1 (WHO fibres) is less than or equal to 40 days.
Tests carried out by qualified institutes such as the Fraunhofer-Institut für Toxikologie und Experimentelle Medizin (ITEM) are recognised. All documents for the relevant test shall be submitted with the application. 

2.1.3 Carcinogenicity index (CI)
The method for determining the carcinogenicity index (CI) is described in BIA work folder no. 7488. The carcinogenicity index (CI) shall be determined for each plant. Without further checking, determinations of the carcinogenicity index (CI) are recognised by qualified institutes accredited in accordance with DIN EN 17025 ff. or operate in conformance with the principles thereof, such as the Fraunhofer-Institut für Silicatforschung (ISC). Determinations of the carcinogenicity index (CI) carried out at other institutes need to be checked and verified by the quality committee.
The sum of the oxides relevant for the carcinogenicity index (CI) and the components not relevant for this must be between 98% and 101%. A carcinogenicity index CI of > 40 is deemed to comply if the sum of the oxides in the test sample included in the calculation formula is greater than or equal to 39.4. 

2.1.4 Intratracheal test (half-life of fibres with a length of more than 20 mm)
It was verified in a short-term intratracheal biopersistence test that the weighted half-life of the fibres with a length of more than 20 mm is less than 40 days.
Tests carried out at qualified institutes such as the Fraunhofer-Institut für Toxikologie und Experimentelle Medizin (ITEM) are recognised. All documents for the relevant test shall be submitted with the application. 

2.1.5 Short-term inhalation test
It has been proved with a short-term inhalation biopersistence test that the weighted half-life of fibres with a length of over 20 mm is less than 10 days.
Tests carried out at qualified institutes such as the Fraunhofer-Institut für Toxikologie und Experimentelle Medizin (ITEM) are recognised. All documents for the relevant test shall be submitted with the application. 

2.1.6 Long-term inhalation test
The absence of relevant pathogenicity or neoplastic changes was identified in a suitable long-term inhalation test.
Tests carried out at qualified institutes such as the Fraunhofer-Institut für Toxikologie und Experimentelle Medizin (ITEM) are recognised. All documents for the relevant test shall be submitted with the application. 

2.1.7 A test report and a test certificate for each test result shall be produced by the appointed test institute. The quality committee and the quality mark holder receive a copy of this. 

The test certificate must contain: 

  • details of the manufacturer
  • description of the fibres examined (e.g. trade name if available)
  • test institute
  • details of the test method
  • time or period of the test
  • date of manufacture of the sample(s) examined
  • chemical composition of the fibres examined
  • test result (incidence of tumours in the intraperitoneal test, half-life in the intratracheal test, half-life in the short-term inhalation test, details of relevant pathogenicity or neoplastic changes, details of the carcinogenicity index) 

2.1.8 In the case of approval using an in-vivo test model, the test report must contain the information listed in the corresponding EU records: 

  • intraperitoneal test: ECB/TM/18(97) rev. 1
  • intratracheal test: ECB/TM/27 rev. 7
  • short-term inhalation test: ECB/TM/26 rev. 7
  • long-term inhalation test: ECB/TM/17 (97) rev. 2 

2.1.9 If new verification methods using the intraperitoneal test are published by the competent authorities, section 2.1.1 of the quality assurance and test specifications shall be reworded accordingly. 

2.2 Verification of conformity 

2.2.1 Verification of conformity between the fibres tested in accordance with section 2.1 and the marketed fibres shall be provided by each quality mark holder in the course of the initial testing, self- and external monitoring and if necessary repeat testing. 

2.2.2 Every quality mark holder shall, before accepting use of the quality mark, undertake to comply with conformity by means of a written statement. This written statement of conformity is filed with the quality association.

 

3 Monitoring 

Monitoring of conformity in accordance with section 2.2 of these quality assurance and test specifications are subdivided into 

- initial testing/ acceptance Monitoring
- self-monitoring / in-house production control
- external monitoring / control testing
- repeat testing. 

The individual monitoring inspections should be conducted together with the monitorings required under construction regulations. All costs for monitorings shall be borne by the quality mark holder or applicant. 

3.1 Initial testing 

3.1.1 Successful initial testing is a condition for the award and use of the quality mark of the Gütegemeinschaft Mineralwolle e.V. Each plant for which the manufacture has applied to the Gütegemeinschaft Mineralwolle e.V. for award of the quality mark must undergo the initial testing. 

3.1.2 The initial testing is carried out in the case of verification of approval with the intraperitoneal test or the intratracheal test by a test of the conformity of the chemical composition of the marketed fibres with the chemical composition of the fibres of the verification of approval. Conformity requires that the chemical composition of the marketed fibres and that of the tested fibres do not exceed the tolerances listed in the annex to these quality assurance and test specifications. 

3.1.3 In case of a supplementary verification of approval with the carcinogenicity index (CI), the initial testing is carried out additionally by means of a test by which compliance of the carcinogenicity index (CI) is proved. The rules of section 2.1.3 apply accordingly. 

3.1.4 A test report shall be produced by the appointed test institute. The quality committee and the quality mark holder each receive a copy of this. 

The test report must contain: 

  • details of the manufacturer
  • description of the fibres examined (e.g. trade name if available)
  • test institute
  • time or period of the inspection
  • chemical composition of the fibres examined
  • as an annex: sampling record (time, place, sampling point, person taking the sample) 

3.1.5 The initial testing also serves to ensure that for the applicant, the personnel and operating conditions for quality-assured manufacture of products made of mineral wool are in place in accordance with these quality assurance and test specifications. The applicant must provide verification that it is able to carry out self-monitoring. 

3.1.6 Appropriate experts or test institutes are appointed by the quality association to carry out the initial testing. A requirements profile must be established for suitability. 

3.2 Self-monitoring 

Every quality mark holder shall carry out continuous self-monitoring (at 7-day intervals at least) to comply with the quality assurance and test specifications. To do this, the quality mark holder shall, on a regular basis, produce records on data carriers or in written form that it must then present to the inspector for external monitoring. The records shall be kept for at least 5 years. 

3.3 External monitoring 

3.3.1 External monitoring is carried out once per six-month period, with a period of at least four months between the successive samplings. Suitable experts or test institutes are appointed by the quality association to carry out external monitoring. A requirements profile shall be stipulated for suitability.
Performance of external monitoring is verified by a sampling record which shall be prepared by the appointed test institute or suitable expert. If the sampling record is compiled in a language other than German or English, a translation into one of these languages shall be enclosed with the sampling record. 

3.3.2 For external monitoring, the quality mark holder shall present the self-monitoring records to the inspector in written form. 

Continuous self-monitoring shall be verified in the sampling record. 

3.3.3 External monitoring, which shall be conducted for each plant, is conducted in the case of verification of approval using the intraperitoneal test or intratracheal test by a test of the conformity of the chemical composition of the marketed fibres with the chemical composition of the fibres in the verification of approval. Conformity requires that the chemical composition of the marketed fibres and that of the tested fibres do not exceed the tolerances listed in the annex to these quality assurance and test specifications.
Sampling as part of external monitoring is required for each plant. For plants with several production lines operating independently, samples must be taken from each individual line. 

3.3.4 In case of a supplementary verification of approval with the carcinogenicity index (CI), external monitoring is conducted additionally by means of a test by which compliance of the carcinogenicity index (CI) is proved. The regulations of section 2.1.3 apply accordingly. 

3.3.5 A test report must be compiled in German or English by the appointed test institute. The quality committee and the quality mark holder each receive a copy of this. 

The test report must contain:

  • details of the manufacturer
  • description of the fibres examined (e.g. trade name, if available)
  • test institute
  • time or period of the inspection
  • chemical composition of the material examined
  • as an annex: sampling record (time, place, sampling point, person taking the sample) 

3.4 Repeat testing 

If as part of the external monitoring deficiencies are identified, the quality committee of the quality association may stipulate repeat testing. The content, scope and time of the repeat testing are decided by the quality committee.
If the repeat testing is also failed, the external monitoring as a whole is deemed to have failed. The procedure in that case is governed by the implementation rules for the award and use of the quality mark for mineral wool by the quality association. 

 

4. Labelling

Products made of mineral wool which provably fulfil the requirements of the respective field of application (sections 1.2 to 1.8) and are labelled accordingly may also be labelled with the quality mark shown below if these also provably fulfil the requirements of these quality specifications and the quality mark has been awarded to the manufacturer by the quality association.

tl_files/Downloads/Grafiken/Grafiken_1/Logo_GM_cmyk_klein.png

The implementation rules for the award and use of the quality mark of the Gütegemeinschaft Mineralwolle e.V. only apply to application of the quality mark.

5. Amendments

Amendments to these quality assurance and test specifications require the prior written approval of RAL.  They come into force on the day on which the board gives written notification of these changes including RAL approval to all members of the association.  The day on which the written notification is sent is the effective date.