SH&E and Product Regulatory Affairs roles and responsibilities

Corporate SH&E_RA (stands for: Safety, Health & Environment and Product Regulatory Affairs)
The Corporate SH&E_RA Department reports directly to a member of the Executive Committee.

The department is responsible for:

  • defining the corporate policy in the field of safety, health and environment, for coordinating and auditing the implementation of this policy and for advising all Agfa organizations and operations.
  • follow up, interpretation, internal communication and facilitation of the implementation of  SH&E technical and -legal aspects of products that Agfa puts on the markets worldwide.
  • giving expert advice to Research and Development, Application and Sales about the safety, health, environmental and regulatory aspects on new and existing Agfa products.
  • coordinating (eco-)toxicological studies on new chemical products used by Agfa
  • filing technical and legal dossiers with authorities
  • assisting the Agfa sales organisations worldwide with respect to technical and legal environmental questions from the customers
  • performing and interpreting life cycle analysis on Agfa products

Safety, Health and Environment Management Committee
The corporate Safety, Health and Environment Management Committee sets the environmental, health and safety policies, targets and priorities for the business groups and business units. The Committee includes one Member of the Executive Committee, responsible for Environment, the Head of Corporate Environment, the Vice Presidents Operations of Agfa Graphics, Agfa HealthCare and Agfa Global Production Materials and the Manager of Corporate Research and Development.

SH&E Management of Agfa manufacturing sites  and Sales Organisations
The local Management of Agfa’s manufacturing sites and Sales Organisations  are responsible for implementing the Corporate Safety, Health and Environment Policy and Guidelines and for complying with the local legislation that is applicable to their operations. In absence of a local Sales Organisation , the HQ Operations department resumes the responsibility.

EHS assessment within the business groups
In the business group Agfa Graphics, the Vice Presidents of the business lines and the Vice President of Operations take care of issues related to safety, health and environmental aspects of products, systems, services and operations. They have their counterparts in the various sales organizations, and take their decisions within SLTs / PLTs (Segment Line Teams / Product Line Teams).

While bringing medical products to the market, the business group Agfa HealthCare  applies a systematic approach to assess the requirements regarding safety, health and environment of products and solutions. For new products the environmental requirements are formally defined in an ‘environmental assessment’. For product changes, those aspects are part of the ‘change assessment’, defining also environmental needs. Products can only be put on the market after it has been verified that all defined needs are met.