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Occupational Health and Safety


Management system for occupational health and safety

Bionorica SE does not have a management system for occupational health and safety for internal employees and workers or for forms of employment such as temporary workers.  These two important functions are institutionalised by the occupational safety specialist in cooperation with the company doctor, the occupational safety committee and the health working group (see below). The legal bases listed below apply to internal employees and other forms of employment such as temporary workers in Germany. These are implemented and controlled by the responsible managers.

Legal bases at the main business location in Germany with regard to occupational health and safety

  • Social Security Code VII
  • Occupational Health and Safety Act (ArbSchG)
  • Occupational Safety Act (ASiG)
  • Chemicals Act (ChemG)
  • Workplace Ordinance (ArbStättV)
  • Hazardous Substances Ordinance (GefStoffV)
  • Regulations of the German Social Accident Insurance (DGUV regulations)
  • COVID-19: Pandemic-related legislation

Rules and principles

  • Technical Rules for Workplaces (ASR), Technical Rules for Hazardous Substances (TRGS), Technical Rules for Hazardous Substances (TRBS), Technical Rules for Biological Agents (TRBA)
  • DGUV rules and principles

Standards and guidelines

  • Association of German Engineers (VDI)
  • German Institute for Standardisation (DIN)
  • German Social Accident Insurance (DGUV) information

Trade union

  • Industriegewerkschaft Bergbau, Chemie, Energie (IG BCE)

Employer’s Liability Insurance Association

  • Berufsgenossenschaft Rohstoffe und chemische Industrie (BG RCI)

Bionorica SE bears reduced responsibility towards externally commissioned specialist contractors (e.g. cleaning companies). The customer, i.e. Bionorica SE, must convince itself of the suitability of the company, point out hazards and specific requirements at the respective site and monitor compliance. The responsibility for hazards resulting from the work tasks themselves lies with the contractor.

Hazard identification, risk assessment and incident investigation

Work-related hazards for employees and other forms of employment (e.g. temporary workers) of Bionorica SE are identified in Germany on the basis of hazard assessments for the workplace or work activity. The procedure of the accident insurance agency is used for this purpose.

Accident events are recorded and processed according to severity and frequency. Measures are derived from this, the implementation of which is verified within the scope of internal audits of occupational safety.
Regular monitoring of compliance with legal requirements is the responsibility of the respective managers. The latter are supported by safety officers who monitor compliance with occupational safety requirements in daily business and report any deviations. The safety officers receive basic training from the accident insurance agent and undergo further training at regular intervals. The manager receives further support from first-aiders as well as fire and evacuation assistants. These persons are specially trained and ensure adherence to the correct procedure in case of danger. They also support managers during annual safety briefings.  

Communication and measures for occupational health and safety

Operating instructions document plant-specific or substance-specific safety requirements, for which managers provide regular instruction. Executives can use existing systems for issues related to 5S – “Sort, Set in Order, Shine, Standardize, Sustain” (e.g. 5S system) to verify the implementation of occupational safety measures. Regular safety audits are carried out in specific areas with a defined group of people (responsible manager, occupational safety specialist, company physician, works council and departmental safety officer).

Four meetings of the Occupational Safety Committee are held each year, thus usually once a quarter. A member of the Executive Board, a representative of the works council, the company physician, all safety officers, the representative of the severely disabled and the occupational safety specialist take part in these meetings. The meetings are held to discuss occupational safety issues and decide upon measures. Due to the participation of a member of the Executive Board in the meetings, there are no restrictions in terms of powers. Furthermore, employee representation is provided for by the works council.

In addition, Bionorica has established the Health Working Group at the main business location in Neumarkt (see GRI 406-3 “Promotion of worker health”).

In the spirit of the continuous improvement process (CIP), existing systems and specifications are tested and scrutinised in the form of regular exercises. These exercises further serve to improve the safety concepts and render the required actions more routine and thus more reliable. Examples include a large-scale exercise for the removal of hazardous substances conducted with the local fire brigade at the Neumarkt site, or an exercise for rescuing employees from a plant. In this exercise, the participants rehearsed the procedure for accidents involving hazardous substances, with the actions of both the employees and the fire brigade being assessed.

In addition, there is a regular exchange of information and on-site inspections at the main business location in Neumarkt, such as in the production facility, where they are conducted together with the accident insurer and the property insurer. 

Occupational health services

The suitability of the company physician is assured by means of the relevant training certificates (physicians with the field designation “occupational medicine” or doctors with the additional designation “industrial medicine”). This is defined in Germany in § 4 of the Occupational Safety Act (ASiG). Furthermore, the qualification must be in line with the potential hazardous situations in operations (e.g. specific industry, hazardous substances). This is verified in the scope of the appointment of the company physician. The appointment procedure is defined in § 2 ASiG. The tasks of company physicians are regulated in § 3 ASiG. Company physicians participate in the identification and elimination of work-related hazards through their involvement in inspections, risk assessments, meetings of the Occupational Safety Committee and accident investigations, as well as the provision of preventive medical check-ups in accordance with the Regulation Concerning Occupational Health Care (ArbMedVV). Company physicians are available to all employees, which is ensured by a representation on the employee intranet along with contact details and a letterbox at the main business location in Neumarkt.

Employee training on occupational health and safety

A basic training document to be mentioned here is our Fire Protection Code. Each employee receives instruction in this on an annual basis. In the GxP area (all guidelines for “good practice”) in the pharmaceutical industry, safety-relevant information is combined in plant or activity-related operating instructions or operating instructions for hazardous substances, and the employees are instructed by their respective managers on a recurring basis. The managers instruct their employees annually on the special hazards resulting from specific work tasks. In this, the manager is supported by the first-aider, evacuation assistant, fire protection assistant and the safety officer. For dangerous, non-routine activities and activities in hazardous areas, there are special release procedures with safety requirements for executing the activities (e.g. hot work permit, work in potentially explosive atmospheres, work in plants). In addition, the transfer of knowledge and the associated review process – especially for standard operating procedures (SOPs), which also serve to prevent accidents – are carried out with the aid of an electronic training system.

Work-related injuries and illnesses

List of accident occurrences
Bionorica SE
(reporting year 2021)
Fatalities Reportable occupational accidents (severe injury,  absence 3 working days) Non-reportable occupational accidents (moderate injury, absence ≤ 3 workding days Commuting accidents 
(on the direct way to/from the place of work)
Near misses
Cut injury/crush injury/stabbing injury 0 1 0 0 0
Tripping/falling/missing 0 1 2 0 0
Hitting/bumping 0 0 1 0 0
Misconduct/human error 0 0 0 0 0
Contact with hazardous substances 0 0 1 0 1
other 0 0 1 0 0
Bionorica SE (994,75 employees)1 0 2 5 6 2
Number of days lost 0 58 0 172 0
rate2 0 0,23 0,59 0,69 0
1,000-man quota 0 2,01 0 0 0
work-related illnesses3 0 0 0 0 0

1 Average number of employees in Germany in the period 01/01/2021 to 31/12/2021
2 Based on 200,000 hours worked
GRI 403-10 - Work-related illness


Company 1,000-man quota in the reporting year
2019 2020 2021
DGUV1 20,97 18,45 19,78
BG RCI2 total 19 17,43 18,92
Chemical industry
15,6 13,82 15,38
Pharmaceutical industry
9,17 8,21 8,93
Bionorica SE 6 3,9 2

1 German Social Accident Insurance
German Social Accident Insurance Institution for the raw materials and chemical industry