Current legislation

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

You are working with hazardous substances in your company?

The following laws are important for you!

The Ordiance on Biological Agfents (BioStoffV)

The Ordinance on Biological Agents (BioStoffV) specifies the occupational health and safety requirements with regard to die risks associated with exposure to biological substances. The term of “biological agents” comprises, besides natural and genetically modified microorganisms such as bacteria, viruses and fungi, also cell cultures and parasites that may cause infectious diseases or allergies in humans or have a toxic effect on them.
Not only employees who work purposefully with such microorganisms (e.g. in the lab) are affected; also employees who do not handle biological agents directly can be exposed to them during their work (e.g. in the wastewater- and waste sectors).
Under the BioStoffV, biological agents are divided into four risk categories, depending on their respective risk of infection. The allergenic and toxic potential is not taken into account here; this is covered by the Ordinance on Hazardous Substances (GefStoffV).

Risk category 1
Biological agents that are unlikely to cause any disease in human beings.

Risk category 2
Biological agents that may cause a disease in human beings and may pose a threat to employees; they are unlikely to spread to the community; there is usually effective prophylaxis or treatment available.

Risk category 3
Biological agents which may cause severe human disease and are a serious hazard to employees; they may present a risk of spreading to the community but there is usually effective prophylaxis or treatment available.

Risk category 4

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

The BioStoffV distinguishes between “targeted” and “non-targeted” activities. Targeted activities are directly oriented towards the biological workplace (e.g. in biological labs).
All other activities are regarded as non-targeted activities. The employees’ work is not targeted directly at biological agents, but the employees are exposed to them during work.

The core element of the BioStoffV is the risk assessment. It has to be carried out for all activities with biological agents of risk categories 1 to 4 prior to taking up the activity, in case of alterations to working conditions, when identifying a contamination at the workplace, or in case of diseases caused by biological agents, and has to be repeated on an annual basis.

Under the BioStoffV, working with water-based, microbiological neutral cleaners is categorized as a non-targeted activity. As a rule, the protective measures listed in the TRBA 500 “General Measures of Hygiene: Minimum Requirements” will suffice to minimize the employees’ risk.

REACh Registration, Evaluation and Authorisation of Chemicals

REACh stands for Registration, Evaluation and Authorization of Chemicals. In future, about 30,000 substances available in the European market will be registered with the new European Chemicals Agency (ECHA) in Helsinki. Manufacturers and importers have to develop measures for the safe use of their substances and communicate them to their customers. Substances of very high concern will undergo a rigorous authorization procedure. The Chemicals Agency will make non-confidential information on substances and related risks accessible in an Internet database. In future consumers will be entitled to information as to whether products contain any substances of very high concern.

Of course all raw materials contained in bio-chem products have been pre-registered!
Read more about REACH at Bio-Circle Surface Technology GmbH

Regulation on GHS

(GHS = Globally Harmonized System), also called CLP Regulation (CLP = Classification, Labelling and Packaging)

It sets out the provisions for the classification, labelling and packaging of substances and mixtures. From 1 December 2010 substances, and from 1 June 2015 mixtures (formerly preparations), will have to be labelled in accordance with CLP; the new labelling may be used since 20 January 2009. However, the label may only be issued in accordance with one law, ether the old or the new one. On the safety data sheet the old classification in accordance with regulations 67/548/EEC or 1999/45/EC will have to be stated until 1 June 2015, the new labelling may be given too. The most striking difference is the alteration of the identification symbols: instead of hazard symbols with black imprints on orange rhombuses there are now nine hazard pictograms. The existing St. Andrew’s Cross (Xi, Xn) will be omitted and replaced by e.g. an exclamation mark. R- and S- (=Risk and Safety) statements will be replaced by H- and P- (=Hazard- and Precautionary) statements.

GHS customer information from Bio-Circle Surface Technology GmbH

Ordinance on Hazardous Substances

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, or carcinogenic. This means that under EC law these substances are placed in at least one category of danger. Based on the labelling of the hazardous substance, working with hazardous substances falls into four protection level categories (protection level concept):

Protection level 1:
Minimum measures. Applies to irritant (Xi), noxious (Xn), and caustic (C) hazardous substances at low exposure if the level 1 protective measures (TRGS 500) suffice.

Protection level 2:
Standard protection level for the handling of hazardous substances. Applies additionally to the same hazardous substances as above in case of higher exposure if the results of a risk assessment show that protection level 1 does not suffice any more. Level 2 protective measures include, but are not limited to, substitution of hazardous substances. Dispensation with substitution has to be accompanied by a reasoned statement. If substitution is not possible, special protective measures have to be taken.

Protection level 3:
Applies additionally in case of handling toxic (T) and very toxic (T+) hazardous substances.

Protection level 4:
Applies additionally if carcinogenic, mutagenic, or fertility-damaging hazardous substances (category 1 or 2) are used.

Risk assessment has to be carried out by the employer before commencing the activity, and must subsequently be updated in case of significant changes in working conditions. 

For many hazardous substances, such as cold cleaners, brake cleaners, scouring paste and many more, Bio-Circle Surface Technology offers substitutes that are not subject to mandatory labelling!


The solvent regulation/VOC directive (31. 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.

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