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Legislation

A variety of laws, regulations and directives are important for occupational health and safety and for the handling of hazardous substances. We act in compliance with them and make sure from the beginning in system- and product development that these are designed in such a way that they represent an alternative to hazardous substances and guarantee better employee protection. 

Below you will find some laws that are important not only for us but also for you. 

You are in charge of occupational health and safety in your company? 

You are working with hazardous substances in your company?
Here are some laws that are important for you!

Factories Act (ArbSchG)

A law that governs the implementation of occupational health and safety measures in order to improve workplace safety and health protection of employees at work. According to the Factories Act the employer has to implement all necessary measures that guarantee and improve workplace safety and health protection of employees at work. For this, he/she has to assess the health hazards existing at the workplace. 

Risk assessment is the prerequisite for the implementation of target-oriented, effective and cost-efficient occupational health and safety measures. The employer has to instruct the employees regarding health hazards and protective measures.

Ordinance on Industrial Safety and Health (BetrSichV)

The Ordinance on Industrial Safety and Health governs the provision of work equipment by the employer, the use of said equipment at work by the employee, and the operational safety of systems requiring monitoring. It includes an extensive protective scheme that can be applied to all hazards posed by work equipment. 

Youth Employment Protection Act (JArbSchG)

The Youth Employment Protection Act is a law designed to protect children and juveniles in the working environment. It aims at protecting children and juveniles from overwork. For instance, juveniles may not do any work that exposes them to the detrimental effects of hazardous substances as defined in the Chemicals Act.  

Chemicals Act (ChemG)

The Chemicals Act is a law for the protection from hazardous substances on the territory of the Federal Republic of Germany. It is part of the law on chemicals. The details of the protective measures are established in ordinances, such as the Ordinance on Hazardous Substances, and in technical rules. In the Chemicals Act numerous EU directives are transposed into German law. This is particularly true for regulations in addition to the REACh Regulation. 

Technical Rules for Hazardous Substances (TRGS)

These rules represent the status quo of safety-related, occupational health-, hygienic and ergonomic requirements for the putting into circulation and handling of hazardous substances. They are established by the Committee for Hazardous Substances (AGS) and serve to substantiate the regulations of the Ordinance on Hazardous Substances. Upon publication in the “Bundesarbeitsblatt”, a journal published by the German Federal Ministry of Labour and Social Affairs, implementation of the TRGS is compulsory. 

REACh: Registration, Evaluation, Authorization and Restriction of Chemicals

REACh stands for Registration, Evaluation, Authorization and Restriction of Chemicals. In future approx. 30,000 substances available in the European market will be registered with the new European Chemicals Agency ECHA in Helsinki. In the middle of 2012 about 7,500 of them were already registered in more than 30,000 registration dossiers. Manufacturers and importers have to develop measures for safe use of their substances and communicate these to their customers. For pure chemicals so-called extended safety data sheets with exposure scenarios are used. The ECHA makes non-confidential information about substances and their hazards available in an Internet database. The core element of the REACh Regulation is characterized by the “no data, no market” principle. On the basis of all available data the ECHA determines a possible hazardous effect on human health deriving a DNEL (derived no-effect level) value. DNEL values are to be understood similarly to workplace limit values (AGW).

Substances of very high concern (SVHC) fall under a separate official approval process and are published in the SVHC list of candidates approx. once every six months. In future consumers will be entitled to know whether products contain any substances of very high concern (SVHC).

Characteristics of very high concern in substances include i.a. being carcinogenic, mutagenic, reprotoxic (CMR) as well as being persistent, bioaccumulative and toxic (PBT), and being very persistent and very bioaccumulative (vPvB).

With regard to REACh and hence to the ECHA candidate list we can confirm that at present all raw materials used in bio-chem products do not contain any substance from the SVHC candidate list, and that they also do not fit the definition of PBT/vPvB substances in accordance with the REACh Regulation Annex XIII. 

VOC Directive 

The solvent regulation/VOC directive (31st BImSchV, 1999/13/EC) limits the emission of volatile organic compounds resulting from the use of organic solvents in certain activities and installations. This applies above all to enterprises that use organic solvents in surface cleaning, coating, varnishing, dry-cleaning, and printing, or in the manufacturing of coatings, adhesives, and pharmaceuticals. Emission limit values are laid down for all plants covered in the regulation, namely for the discharge by means of a smokestack, and also for fugitive emissions through windows, doors, and exhaust systems. The plant operator has to set up the plant in such a way that the emission limit values laid down will be observed. Instead of complying with these limit values a reduction scheme may be implemented. One can choose from three different reduction schemes. The application of the “Simplified Record”, in which solvent contents are limited by using substitutes with maximum admissible solvent levels, is particularly interesting and simple in this context. 

GHS (Globally Harmonized System) and CLP Regulation (Classification, Labelling and Packaging of Substances and Mixtures):

In Europe the Globally Harmonized System for Classification and Labelling is implemented through the CLP Regulation (1272/2008/EC). It is implemented parallel to and closely linked with the REACh Regulation. The CLP Regulation sets out the provisions for the classification, labelling and packaging of substances and mixtures. Since 1 December 2010 substances, and since 1 June 2015 also mixtures (formerly preparations), have to be labelled in accordance with CLP. The most striking difference is the alteration of the identification symbols: instead of hazard symbols with black imprints on orange rectangles there are now nine different hazard pictograms. The former St. Andrew’s Cross (Xi, Xn) has been omitted and replaced by e.g. a diamond with a red border and a black exclamation mark. R- and S- (=risk and safety) statements have been replaced by H- and P- (=hazard- and precautionary) statements. In addition, signal words (ATTENTION or WARNING) are printed on to emphasize the danger. Not only symbols and depictions change, there are also new hazards classes and altered classification criteria. The former EU law only knew 15 categories of danger, such as “corrosive” or “highly flammable”. The new CLP Regulation however differentiates between 28 categories of danger. In addition to the hazard classes, hazard categories are introduced that provide a gradation of hazards within one hazard class. For instance, in the “flammable liquids” hazard class there are three categories that depend on the flashpoint (cf. Chapter 2.6 Appendix I CLP Regulation). In Germany, plenty of laws, regulations and technical regulations refer to the classification and labelling of chemicals in accordance with EU directive 67/548/EEC or 199/45/EC. These also require revision and adaptation in accordance with the CLP Regulation. The most important regulations affected here are the Ordinance on Hazardous Substances (Gefahrstoffverordnung – GefStoffV) and the Ordinance on Biological Substances (Biostoffverordnung – BioStoffV).

Ordinance on Hazardous Substances (GefStoffV)

The Ordinance on Hazardous Substances (Gefahrstoffverordnung – GefStoffV) sets out the provisions for protective measures for employees when handling hazardous substances. Hazardous substances are substances, mixtures, or products that exhibit certain physical or chemical properties, such as highly flammable, toxic, caustic, carcinogenic, or persistent. This means that under EC law these substances are placed in at least one category of danger.

The implementation of the CLP systems affects: 

  • the risk assessment, 
  • the operating instructions, 
  • the instructions of staff, 
  • the hazardous substance register, and 
  • in-house labelling, which all have to be examined. 

Ordinance on Biological Substances (BioStoffV)

The ordinance on the protection of workers from risks related to exposure to biological agents at work (Biostoffverordnung – BioStoffV) governs work-related activities involving biological agents. It sets out the provisions for protective measures for employees when handling such substances. The term “biological agents” encompasses natural and genetically modified microorganisms such as bacteria, viruses, fungi, cell cultures, and parasites, which may cause infectious diseases in or have toxic effect on humans.

This does not only concern employees who purposefully work with these microorganisms (e. g. in the lab). Also employees who do not handle biological agents directly may be exposed to them at work (e. g. in the fields of wastewater and waste). The BioStoffV divides biological agents into four risk groups that lead to protection levels. Biological agents are classified according to their level of risk of infection. Protection levels range from access restrictions to physical cut-off.

Risk group 1

Biological agents which are unlikely to cause human disease. 

Risk group 2

Biological agents that can cause human disease and may be a hazard for workers; they are unlikely to spread to the community.

Risk group 3

Biological agents which may cause severe human disease and may be a serious hazard to workers; they may present a risk of spreading to the community but there is usually effective prophylaxis or treatment available.

Risk group 4

Biological agents which cause severe human disease and are a serious hazard to workers; they may present a high risk of spreading to the community; there is usually no effective prophylaxis or treatment available.

Contact

Should you have any questions or require additional information, you are welcome to contact us at any time by phone, fax or email. 

We are looking forward to assisting you with advice and support! 

  • Phone no.: +49(0)5241 9443-0 
  • Fax no.: +49(0)5241 9443-44
  • Email: service@bio-circle.de 

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