Cover: The MAK Collection for Occupational Health and Safety

The MAK Collection for Occupational Health and Safety

German Research Foundation – Permanent Senate Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area
(MAK Commission)

ISSN 2509-2383


 

 

Peer Review

The Permanent Senate Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area (Ständige Senatskommission zur Prüfung gesundheitsschädlicher Arbeitsstoffe) publishes the results of its activities in the four article categories “MAK Value Documentations”, “Assessment Values in Biological Material”, “Air Monitoring Methods” and “Biomonitoring Methods”. The publications are discussed intensively (in working groups and in the plenum) by 25 to 50 experts present at the meetings of the Commission and are released only under universal agreement. The completed evaluations of MAK and BAT Values and of the other classifications are made public on July 1st of every year in the List of MAK and BAT Values and on the homepage of the Commission at the DFG.

The preview list can be found here (in German only):

https://www.dfg.de/download/pdf/dfg_im_profil/gremien/senat/arbeitsstoffe/ankuendigungsliste.pdf

This is followed by a six-month public consultation period. During this time, the manuscripts are made available on demand, and the scientific comments received are discussed within the Commission and taken into consideration before the final publication of the respective documentations. In addition, all the documents are scientifically assessed and commented upon by the Federal Institute for Occupational Safety and Health (Bundesanstalt für Arbeitsschutz und Arbeitsmedizin (BAuA)) and Subcommittee III of the Committee on Hazardous Substances (Ausschuss für Gefahrstoffe (AGS)) of the Federal Ministry of Labour and Social Affairs (Bundesministerium für Arbeit und Soziales) during the period of public consultation. Changes made after public consultation are indicated in the subsequent List of MAK and BAT Values.

In the case of the Air Monitoring Methods and Biomonitoring Methods an extensive discussion and review process takes place within the expert groups. Before publication, the methods are tested independently by another laboratory (method verification). Furthermore, the method descriptions are critically evaluated and discussed at the meetings, also by participating guests who are not members of the Commission. Finally, the method descriptions are released for publication.

Further details of how the Commission operates can be found here:

https://www.dfg.de/en/dfg_profile/statutory_bodies/senate/health_hazards/how_commission_operates/

Conflict of interest

As a scientific journal The MAK Collection for Occupational Health and Safety does not pursue any commercial purposes. In view of the responsibility of the Commission, scientists are ad personam appointed members in their capacity as experts and not as representatives of the institutions or companies in which they work. Besides members, also Guests and Permanent Guests participate in the Commission’s work. Guests may be invited as scientific experts for specific questions and tasks, to support the Commission in their evaluations and decisions. As Permanent Guests, scientists and other experts are appointed with either advisory function, research assignments or official responsibilities within public authorities. As they belong to institutions potentially receiving the Commission’s advice they have no voting rights. In this way, possible conflicts of interest should be excluded from the start. Before every consultation, all participants are requested to report potential conflicts of interest; any such are documented and evaluated, and consequences for the involvement of the participant in the discussion and voting process are established.

Detailed information about how the Commission deals with conflicts of interest can be found here:

https://www.dfg.de/en/dfg_profile/statutory_bodies/senate/health_hazards/conflicts_interest/

Ethical rules

The Permanent Senate Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area (Ständige Senatskommission zur Prüfung gesundheitsschädlicher Arbeitsstoffe) primarily uses data from publicly available studies for its work (published peer-reviewed in-vitro studies, animal experiments and studies in humans); in addition, the Commission considers unpublished animal studies which conform with OECD guidelines, also from the industrial context if the complete study report is available. The Commission does not carry out such studies itself nor does it give any orders to carry them out.
Adherence to the prescribed legal and ethical standards with regard to animal experiments and volunteer studies has been checked in the context of research grants and/or in connection with the publication of the results. Adherence to the legal and ethical requirements also applies when collecting study results. If there are any doubts whether ethical standards were met, studies will not be included in the final evaluation.

Authors’ Guidelines

All authors of an article are explicitly named and as such insure their substantial partake in the genesis of said article as well as their consent with content and form of the respective article.

The journal The MAK Collection for Occupational Health and Safety contains articles in the four categories “MAK Value Documentations”, “Assessment Values in Biological Material”, “Air Monitoring Methods” and “Biomonitoring Methods”. The editors guarantee compliance with scientific publication standards.

All articles are published under the Creative Commons Attribution 4.0 International (CC BY) License.

https://creativecommons.org/licenses/by/4.0/deed.en

Articles may contain elements (such as figures or tables) that are not covered by the CC-BY-license 4.0. In such cases, a separate copyright notice is added and the primary source is named.

The four article categories are assigned to two article types. The substance documentations, i.e. “MAK Value Documentations” and “Assessment Values in Biological Material”, are review articles, whereas the analytical methods, i.e. “Air Monitoring Methods” and “Biomonitoring Methods”, are research articles.

The contents of the corresponding article categories are shown in detail here:

 

Article type: “review”

MAK Value Documentations:

Assessment Values in Biological Material:

  • Abstract with key information on the human toxicity of a workplace chemical
  • Tabular presentation of the assessment resulting from the review for the individual endpoints of toxicity and physico-chemical properties
  • Reference to any existing publications of the Commission on this substance
  • Descriptions of the studies identified in the literature search and deemed relevant and reliable after critical assessment:
  • Toxic effects and mode of action
  • Toxicokinetics and metabolism
  • Human toxicity (effects in humans, animal ­experiments, in vitro studies, New Approach ­Methods) for the endpoints: acute and ­subchronic/chronic toxicity, irritation, sensitisation, ­reproductive toxicity, genotoxicity, carcinogenicity
  • Metabolism and toxicokinetics
  • Critical toxicity
  • Exposure and effects
  • Relationship between external and internal ­exposure
  • Relationship between internal exposure and ­effects
  • Background exposure
  • Evaluation of all endpoints: Derivation of an 8-hour occupational exposure limit value (MAK value) and a short-term value, further classifications (­carcinogenicity, germ cell mutagenicity, pregnancy risk group) and designations (sensitisation, skin absorption)
  • Selection of indicators (substance/metabolite, ­matrix)
  • Analytical methods (established analytical methods)
  • Derivation of assessment values in biological ­material:
    • Derivation of a biological tolerance value (BAT value);
      If necessary, evaluation of a pregnancy risk group for the BAT value
    • Biological guidance value (BLW)
    • Biological reference value (BAR)
    • Exposure equivalents for carcinogenic substances (EKA)
  • Interpretation (indications of possible (­non-occupational) influencing factors)
  • Competing interests
  • References

 

Article type: “research”

Air Monitoring Methods:

Biomonitoring Methods:

  • Abstract with key information on the content of the article, both with regard to the legal background (limit values) and the technical implementation of appropriate workplace measurements
  • Abstract with key information on the content of the article
  • Characteristics and general principle of the ­method taking into account the European normative ­requirements as well as general information on the substance
  • Characteristics of the method;
    General information on the substance
  • Equipment, chemicals and solutions used, including standards
  • General principle of the method; equipment, ­chemicals and solutions; including standards
  • Sampling and sample preparation
  • Operating conditions and analytical determination
  • Calibration and calculation of the analysis result
  • Calibration; calculation of analysis results; standardisation of measurement results and quality assurance
  • Reliability of the method (based on requirements of CEN and ISO standards: precision, recovery, expanded measurement uncertainty, influence of humidity, influence of temperature, limit of quantification, capacity of the sampling system, storage stability, selectivity and interference)
  • Assessment of the method (precision, accuracy, matrix effects, detection and determination limits, interference)
  • Discussion
  • Conflicts of interest
  • References

 

Further information on the Journal Policy of German Medical Science (GMS) can be found here:

https://www.egms.de/en/journals/policy.htm

Latest update: 24.11.2023