Other standardisation bodies

National standards institutions (i.e. in Metrology) are responsible for developing, agreeing, and adopting national and international standards, withdrawing conflicting national standards to give a coherent national catalogue. National standardisation bodies work across multiple industries, businesses, government offices and consumers to develop standards that support national policy objectives (e.g. economic competitiveness, consumer and public interests). National standardisation bodies work in close collaboration with national government offices, departments, and/or ministries responsible for general policy on standards and their application in collaboration with other public bodies such as national measurement institutes and/or the national accreditation body.

The main role is the link between TGs and industrial standards at a national level. The national standardisation body exercises administrative responsibilities by undertaking unified management, supervision and overall coordination of standardisation work in a particular country.

It can provide experts to join the (Ad Hoc) expert groups supporting the development of an OECD project and/or participate in interlaboratory comparisons (ILCs). Metrology institutes can also provide comments on the draft TG/GD during the commenting phase.

These bodies often have their own funding from the government to get involved in OECD TGs. This may also be supplemented with additional funded projects in areas such as advanced materials or New Approach Methodologies (NAMs) or from contract work for industry.

British Standards Institution (BSI), AFNOR groupe, National Standard Authority of Ireland (NSAI), German Institute for Standardization (DIN)

Generally, national institutes are represented by international standardisation bodies in OECD bodies. These can be organised at a regional level (e.g. Comité Européen de Normalisation (CEN)) or at a global level (e.g. International Standards Organisation (ISO)). 

CEN is a private international non-profit organisation, which is a provider of voluntary European Standards and related products and services. It works in international cooperation preliminary with ISO, but also with OECD. National standardisation bodies are represented by their affiliates. The CEN standards programme is executed by the Technical Committees (TCs), the CEN-CENELEC Management Centre (CCMC), and other bodies. There are 386 technical bodies, 59 subcommittees and 1604 working groups. Nanotechnologies are covered by CEN/TC 352. 34 national Member Countries through their national standardisation bodies (CEN) constitute the final decision-makers within CEN. The organisational structure is strongly aligned with that of ISO.

ISO is an independent, non-governmental organisation that brings together 167 national standardisation bodies. Through its technical committees (TCs), ISO brings together worldwide experts to develop internationally accepted standards. ISO TCs usually work jointly on standards when necessary, so standards that cross remits of TCs can be effectively managed. ISO committees have participating countries, with other bodies (such as industry bodies and OECD) sometimes acting only as observers. Consensus must be reached by the participating countries for a standard to be approved and published. ISO and OECD have different stakeholders involved, with ISO not having such a political element as OECD. ISO standards are often developed quicker than OECD TGs. ISO Standards are also voluntary and do not have to be used by industry, whilst OECD TGs are required for regulatory testing.

ISO and CEN directly participate in the OECD Test Guidelines Programme (TGP) by participating in meetings and thus ensuring the alignment of terminology, avoiding work duplication, and engaging the expert knowledge required to cover a particular topic.

The Comité Européen de Normalisation (CEN) does not have a formal role in the OECD Test Guidelines Programme (TGP), but it does develop new standards that can also be used as part of regulatory compliance. CEN can provide scientific advice or set international standards in non-animal (in vitro) assays and computational tools for screening of endocrine active substances, and in the development of harmonised templates for chemical databases. CEN contributes to the use of New Approach Methodologies (NAMs) in risk assessment (ongoing).

Similarly, the International Standards Organisation (ISO) does not have a formal decision-making role in the OECD Test Guidelines Programme (TGP) but can act in an advisory capacity. ISO chairs are involved in relevant OECD committees, for example, the Chair of ISO TC229 participates at OECD Working Party on Manufactured Nanomaterials (WPMN). ISO experts and TC Chairs could be engaged during the development of TGs and could provide expertise and advice as part of Expert Groups. Shared terminology between OECD and ISO could be improved. Also, as industries will often use ISO standards in their daily work, TG developers should be aware of existing ISO standards that may be available in their area of interest. Some ISO standards may also be used alongside OECD TGs, such as those for characterisation and measurement (e.g. ISO ISO/TR 13014:2012 Nanotechnologies — Guidance on physico-chemical characterization of engineered nanoscale materials for toxicologic assessment, or ISO/TS 19337:2016 Nanotechnologies — Characteristics of working suspensions of nano-objects for in vitro assays to evaluate inherent nano-object toxicity).

CEN or ISO does not work directly with OECD TGs, but there are some experts from both international bodies that will be experts at the OECD as well. CEN and ISO Standards are paid for by the user, whilst experts usually work on standards development using their own funding.

Standardisation initiatives such as the Versailles Project on Advanced Materials and Standards (VAMAS) support world trade in products dependent on advanced materials technologies, through international collaborative projects aimed at providing the technical basis for harmonised measurements, testing, specifications, and standards. VAMAS pre-standards research activities are organised into technical committees called Technical Working Areas (TWA), which are overseen by a Steering Committee (SC) consisting of representatives of each of the members of VAMAS. The SC is responsible for policy, programme planning, approval of new TWAs and projects, appointment of TWA Chairs and monitoring the progress of the TWAs. VAMAS has a liaison with ISO OECD and other various initiatives and associations.

The Versailles Project on Advanced Materials and Standards (VAMAS) pre-standards research activities can provide a basis for the development of standardised or harmonised test guidelines (See pre-OECD phase). VAMAS coordinate several interlaboratory comparisons; the list of active projects can be consulted on VAMAS website. Experts from VAMAS can participate in OECD (Ad hoc) expert groups and support the reply to comments emitted on draft OECD TGs/GDs.

Similarly to the OECD, VAMAS funding is in the power of Member countries.