Appendix D - 6 Classification, Labeling, Materials Safety Data Sheets - European Union
-- May '97
The classification and labeling of Dangerous Substances is governed by the Directive 67/548/EEC (DSD) and its
various amendments; (79/831/EEC, 91/325/EEC). The annexes to the Directive consist of:
| Annex I | list of Dangerous Substances officially classified |
| Annex II | symbols and indications of danger |
| Annex III | Risk Phases |
| Annex IV | Safety Phases |
| Annex V | Testing Methods |
| Annex VI | The Classification and Labeling Guide |
| Annex VII | Base-set (information required in an information dossier) |
| Annex VIII | Additional Information |
| Annex IX | Provisions relating to child-resistant fastenings and to tactile warnings of danger |
The regulating text concerning classification and labeling of Dangerous Preparations (including alloys) has
been published under Directive 88/379/EEC (DPD) and its various amendments.
Both the DSD and the DPD are of general application and cover the activities of the non-ferrous metals
industries:
- classification and labeling of metals, refer to DSD:
- classification and labeling of alloys refer to DPD.
Material Safety Data Sheets (MSDS) are covered under Directive 91/115/EEC.
It is the responsibility of the manufacturer or importer of dangerous substances and preparations to
classify, label and provide MSDS according to the regulations imposed by the various Directives.
Labels
Labeling follows from classification, and labels must indicate the various (danger) symbols, risk phrases and
safety phrases summarized in Appendix D - 7.
The classification and labels required for nickel and its common compounds are given in Appendix D - 8.
The DPD applies to preparations such as mixtures of chemicals which may contain one or more hazardous
ingredients. At present, the rules which apply to the classification of such products are highly
inflexible so that alloys are treated in the same way as simple mixtures. Also, very low
concentrations of the hazardous constituents are sufficient to classify (label) the "preparation" as
hazardous. For example, mixtures (alloys) containing more than 0.1% of a (EU) category 1 carcinogen (e.g.
NiO) will be similarly classified as carcinogenic. Likewise alloys containing more than 1% of a Category 3
carcinogen (e.g. Ni metal) will be similarly classified. The consequence is that, at present, most
nickel-containing special steels and alloys will be classified as carcinogenic and will need to carry MSDS to
this effect.
In contrast to many organic chemicals, the toxicological effects of metals and their alloys are frequently
dependent on the form in which they are placed on the market. Thus many metals and alloys are not dangerous
in massive form, but may be so when in particulate form.
In Annex V of the 12th Adaptation to Directive 67/548/EEC special articles concerning metals and alloys have
been introduced and are required below.
Art 8.1: Metals in Massive form
"These substances are classified in Annex I to Directive 67/548/EEC or shall be classified in accordance with
Article 5 (2) of Directive 67/548/EEC. However some of these substances although classified in accordance
with Article 2 of Directive 67/548/EEC do not present a danger to human health by inhalation, ingestion or
contact with skin in the form in which they are placed on the market. Such substances do not require a label
according to Article 16 of this Directive."
However, all the information which should have appeared on the label shall be transmitted to the user by the
person responsible for placing the metal on the market.
Art 9.2: Alloys, Preparations containing polymers, preparations containing Elastomers.
"These preparations shall be classified according to the requirements of Article 3 and labeled according to
the requirements of Article 7 of Directive 88/379/EEC. However, some of these preparations although
classified in accordance with Article 3(3) do not present a danger to human health by inhalation, ingestion
or contact with the skin in the form in which they are placed on the market. Such preparations do not require
a label according to Article 7; however all the information which would have appeared on the label shall be
transmitted to the professional user by means of an information system in a format foreseen in Article 10 of
the above mentioned Directive".
In both cases, metals and alloys in massive form are classified but not labeled. However, all the information
must be given to the user usually through material safety data sheets.
Material Safety Data Sheets (MSDS)
Any person established within the EU who is responsible for placing a dangerous substance or preparation on
the market, whether the manufacturer, importer or distributor, shall supply the recipient who is an
industrial user of the substance or preparation with a safety data sheet containing the information set out
Appendix D - 9.
The information shall be provided free of charge at the latest when the substance or preparation is first
supplied and thereafter following any revision due to any significant new information regarding safety and
protection of health and the environment.
Member States may make the placing of dangerous substances or preparations on the market in their territory
subject to the use of their official language or languages for the compilation of the safety data
sheet.
