GHS (CLP/GHS system) IN PRACTICE - Agencija za hemikalije

1.3 Does GHS cover all substances and mixtures?CLP/GHS Rulebook shall not apply to:• Radioactive substances and mixtures;• Substances and mixtures in transit;• Transport of dangerous chemicals;• Non-isolated intermediates;• Substances and mixtures for scientific research and development, which are not placed on the marketbut are used under controlled conditions where their exposure is reduced;• Waste as defined by the Law on Waste Management (“Official Gazette of RS” No 36/09); and• Substances and mixtures which are subject to customs supervision and placed in the customswarehouse or free zone with the view to reexportation or transit, provided that such chemicals do notundergo the process of working or processing.CLP/GHS Rulebook shall also not apply to substances or mixtures which are placed on the market in the finalform as:• Drugs and medical devices used in human or veterinary medicine;• Cosmetic products;• Food, feeding additives and aromas; and• Feedstuff and additives for feedstuff.However based on CLP/GHS Rulebook hazardous substances or mixtures to be placed on the market, must beclassified before placing them on the market, independently of the actual tonnage manufactured, imported orplaced on the market.Hazardous substances or mixture are those which fulfil the criteria relating to physicalhazards, health hazards or environmental hazards, laid down by CLP/GHS Rulebook!1.4 Does GHS cover some articles?No, normally not. However, the obligation to classify and label applies to producers or importers of certainexplosive articles which meet the definition set out in chapter 2.1.1. CLP/GHS Rulebook before placing them onthe market. Other articles are not subject to any classification, labelling and packaging provisions of the CLP/GHSRulebook.1.5 Must I also classify medical devices, medicinal products, waste, food, additives and aromas as well asfeedstuff and additive for feedstuff?Medical devicesSubstances and mixtures which are medical devices as defined in Law on Drugs and medical Devices (“OfficialGazette of RS” No 30/10) and which are invasive or used in direct physical contact with the human body areexempted from the provisions of CLP/GHS Rulebook on the whole if they are in the finished state and intended forthe final user:• Substances and mixtures that are invasive or used in direct physical contact with the human body wouldinclude cochlear implants, implantable cardiac pacemakers, implantable defibrillators and implantablenerve stimulators;• Substances and mixtures that are invasive or used in direct physical contact with the human body wouldinclude sutures, catheters, stents, balloon catheters and wound dressings and• Substances and mixtures would include reagents for diagnostic of Hepatitis C and HIV, self-diagnosisdevices for the measurement of blood sugar and IVD Analysers.6