02/02/2018

1. Definitions

Manufacturer
Natural or legal person who produces packagings at one or a number of manufacturing places and bears responsibility for compliance with the stipulations of the design type approval and is obliged to mark the dangerous goods packagings.

Manufacture
Manufacture/production includes the conversion of raw material and/or semi-finished products and assembly of components into packagings. The remanufacturing and reconditioning of packagings are also included here and, correspondingly, the relevant measures for large packagings and for remanufacturing and repairing IBCs and their routine maintenance, unless the service is performed by the owner of the IBC, whose place of residence and name or mark are fixed permanently on the IBC. Manufacture may also cover activities by users when essential manufacturing steps are performed in conjunction with filling the packaging/IBC.

Both the manufacturing of dangerous goods packagings abroad for which a design type approval has been granted in Germany and the manufacturing of packagings in Germany for which a design type approval has been granted abroad are subject to the BAM Dangerous Goods Procedural Rule BAM-GGR 001.

Production site
Plant at one location which has proved its qualifications when acquiring a BAM design type approval. The qualifications include the necessary machines and equipment to manufacture packagings and the assigned personnel. The qualifications of a production site are documented by the BAM by allocating a manufacturer’s mark.

Quality assurance
The 2 pillar principle of quality assurance is:

  • the recognition of the QAP

    • frequent audits of the QAP
  • monitoring measures by

    • frequent monitoring tests

2. Requirements for the manufacture of dangerous goods packagings

1. The packaging has passed the design type test
2. The manufacturer needs a quality assurance programme (QAP) recognised by the BAM
3. The manufacturer needs a monitoring contract with the BAM or a monitoring body recognised by the BAM

  • an audit has to be done before the first delivery of products.

These are the requirements for an approval. Without an approval, the manufacturing of dangerous goods packaging is forbidden. Please note that the manufacturer is not necessarily the holder of the approval!

The approval holder may let several manufacturers produce the packaging. These manufacturers have to

  • meet the requirements by 1 and 2
  • be mentioned in the approval.

3. Recognition of quality assurance programmes (QAP)

3.1 Which companies need a QAP recognised by the BAM?

1. Companies manufacturing, remanufacturing and reconditioning packagings
2. Companies manufacturing, remanufacturing and repairing intermediate bulk containers (IBCs)
3. Companies manufacturing and carrying out relevant measures on large packagings
4. Articles 1-3 also apply to companies producing packagings in Germany for which a design type approval has been granted abroad.


3.2 Requirements of QAP

The procedure is written down in the BAM Dangerous Goods Procedural Rule BAM-GGR 001 and its appendices.

3.3 Application documents

  • informal application
  • monitoring contract
  • audit protocol
  • audit report
  • quality manual.

If the QAP-recognition is based on an ISO 9001-certification:

  • issued certificate
  • confirmation of the certification body that the audits carried out included the manufacturing of dangerous goods packagings and the fulfilled requirements of BAM GGR 001, BAM-GGR 005 and – where applicable – BAM GGR 006 in the quality manual.

The recognition is done by the BAM:

Federal Instituite for Materials Research and Testing
Working Group "Quality Assurance an Information Management"
D-12200 Berlin

The recognition is a charged service.

4. Monitoring the manufacturing

4.1 Which companies have to be monitored?

1. Companies manufacturing, remanufacturing and reconditioning packagings
2. Companies manufacturing, remanufacturing and repairing intermediate bulk containers (IBCs)
3. Companies manufacturing and carrying out relevant measures on large packagings
4. Articles 1-3 also apply to companies producing packagings in Germany for which a design type approval has been granted abroad.


4.2 Audits and monitoring tests

To assure the effectivness of the QAP, the manufacturer has to sign a monitoring contract with the BAM or a monitoring body recognised by the BAM.
The body

  • normally audits the QAP every 3 years
  • does yearly monitoring tests.

Both measures are services charged by either the BAM or the monitoring body.

When choosing a monitoring body, please check if it is recognised for the measures needed (can do audits and/or monitoring tests).

Monitoring bodies (PDF)
Foreign authorities with existing agreement for the conduction of audits and monitoring tests (PDF)