2. 2. 2. Limits for carcinogenic, mutagenic and reprotoxic substances (CMR substances) in insulation materials

According to Directives 67/548/EEC and 1999/45/EC, respectively, CMR substances are defined as follows:

• Carcinogenic substances and preparations are substances and preparations which, if they are inhaled or ingested or if they penetrate the skin, may induce cancer or increase its incidence.
• Mutagenic substances and preparations are substances and preparations which, if they are inhaled or ingested or if they penetrate the skin, may induce heritable genetic defects or increase their incidence.
• Reprotoxic substances and preparations are substances and preparations which, if they are inhaled or ingested or if they penetrate the skin, may produce, or increase the incidence of, non-heritable adverse effects in the progeny and/or an impairment of male or female reproductive functions or capacity.

These definitions of CMR substances largely correspond with those given in the CLP Regulation (Regulation (EC) No 1272/2008). However, the Regulation uses the term "mixture" instead of the term "preparation", which has been used in previous legislation.

Substances that have been classified as carcinogenic, mutagenic or reprotoxic in accordance with Directive 67/548/EEC or Regulation 1272/2008 (see table) must not exceed the following percentages (m/m):

 

Directive 67/548/EEC  (Annex VI)	CLP Regulation 1272/2008 (Annex I)	% m/m
Carcinogenic Categories 1, 2: R45, R49	Carcinogenicity Categories 1A, 1B: H350; H350i	≤ 0,1 %
Carcinogenic Category 3: R40	Carcinogenicity Category 2: H351	≤ 1 %
Toxic to reproduction Categories 1,2: R46	Germ cell mutagenicity Categories 1A, 1B: H340	≤ 0,1 %
Toxic to reproduction Category 3: R68	Germ cell mutagenicity Category 2: H341	≤ 1 %
Toxic to reproduction Categories 1,2: R60, R61	Reproductive toxicity Categories 1A, 1B: H360	≤ 0,5 %
Toxic to reproduction Category 3: R62, R63	Reproductive toxicity Category 2: H361	≤ 5 %
R64	Reproductive toxicity: Adverse  effects on or via lactation: H362	≤ 1 %

Exception: Until entry into force of the 1st ATP (adaptation to technical progress) to the CLP Regulation, Regulation (EC) No 790/2009, boric acid and borates are admissible up to the specific concentration limits that have been defined for labelling.

Supporting documents:
Safety data sheet in accordance with Regulation (EC) No 1907/2006 as amended by Regulation (EU) No 453/2010, or manufacturer's confirmation.

All products bearing one of the following organic labels meet these criteria:

• natureplus quality label
• Österreichisches Umweltzeichen eco label
• Blauer Engel/Blue Angel.

 

Alternatively, the corresponding baubook declaration may serve as evidence (www.baubook.info/oea).

Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006.

 

Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances, including adaptations to technical progress.