Chemical regulations
13 de December de 2023Many of Scharlau products have their specifications regulated and determined by different international regulations. In such cases, the regulatory standard appears explicit in the product description.
The different types of regulations to be taken into account and the standards included in product descriptions are shown below.
REACH / CLP
REACH stands for “Registration, Evaluation, Authorisation and Restriction of Chemicals”. REACH is a European Union regulation that entered into force in 2007 and aims to protect human health and the environment by regulating the use of chemicals in industrial products and processes.
Classification of substances
The EU has aligned the CLP hazard classes with those from the UN GHS (Globally Harmonised System) closely matching the DSD categories for danger. Hazard classes are broken down further into hazard categories. The total number of hazard classes has increased.
CLP Hazard Classes and Categories
Physical hazards |
Explosives (Unstable explosives, Divisions 1.1, 1.2, 1.3, 1.4, 1.5, and 1.6)D |
Flammable gases (Category 1 and 2)D |
Flammable aerosols (Category 1 and 2)D |
Oxidising gases (Category 1)D |
Gases under pressure (Compressed gas, liquefied gas, refrigerated liquefied gas, dissolved gas) |
Flammable Liquids (Category 1, 2 and 3)D |
Flammable solids (Category 1 and 2)D |
Self-reactive substances and mixtures (Type A, B, C, D, E, F & G) (Types A and B)D |
Pyrophoric liquids (Category 1)D |
Pyrophoric solids (Category 1)D |
Self-heating substances and mixtures (Category 1 and 2) |
Substances and mixtures which in contact with water emit flammable gases (Category 1, 2 and 3)D |
Oxidising liquids (Category 1, 2 and 3) (Cat 1 and 2)D |
Oxidising solids (Category 1, 2 and 3) (Cat 1 and 2)D |
Organic peroxides, (Type A, B, C, D, E, F & G) (Types A to F)D |
Hazardous to the ozone layerD |
Health hazards |
Acute toxicity, (Category 1, 2, 3 and 4)D |
Skin corrosion/irritation, (Category 1A, 1B, 1C and 2)D |
Serious eye damage/eye irritation, (Category 1 and 2)D |
Respiratory or skin sensitisation (Category 1)D |
Germ cell mutagenicity, (Category 1A, 1B and 2)D |
Carcinogenicity, (Category 1A, 1B and 2)D |
Reproductive toxicity (Category 1A, 1B and 2) category for effects on or via lactationD |
Specific target organ toxicity (STOT) – single exposure ((Category 1, 2)Dand Category 3 for narcotic effects and respiratory tract irritation |
Specific target organ toxicity (STOT) – repeated exposure (Category 1 and 2)D |
Aspiration hazard (Category 1)D |
Environmental hazards |
Hazardous to the aquatic environment (Acute Category 1, Chronic Category 1, 2, 3, and 4)D |
Hazardous to the ozone layerD |
DCLP hazard classifications (whole hazard class or the highlighted categories) which reflect “classified as dangerous” under DSD/DPD.
Hazard Pictograms
Hazard pictograms are related to hazard classes.
According to the CLP, risk (R) and safety (S) phrases are replaced by hazard (H) and precautionary (P) statements respectively. The H and P statements are coded using a unique code which consists of one letter and 3 numbers as follows:
- The letter H or P (some hazard statements carried through from DSD and DPD which are not yet included in the GHS are coded according to the EUH).
- A digit designating the type of hazard (i.e. 2 for physical hazard).
- Two digits corresponding to the sequential numbering of hazards (i.e. flammability codes from 220 to 230).
(1) Carcinogenic, mutagenic, toxic to reproduction / (2) Specific target organ toxicity
Pharmacopoeia
Pharmacopoeias are official standards, which define requirements for the qualitative and quantitative composition of medicines, the test to be carried out on medicines and on substances and materials used in their production. The purpose of the pharmacopoeias is to promote public health by the provision of recognised common standards as a basis for the safe use of medicines by patients. Scharlab follows the most important pharmacopoeias in the world to control the quality of the substances suitable to be used in pharmaceutical industry.
- EP or Ph. Euris the European Pharmacopoeia and it is published by the European Directorate for the Quality of Medicines & Healthare (EDQM).
- BPis the British Pharmacopoeia and it is produced by the British Pharmacopoeia Commission Secretariat of the Medicines and Healthcare Products Regulatory Agency.
- USP-NFis a combination of two compendia, the United States Pharmacopoeia and the National Formulary, and it is published by the non-profit organisation U.S. Pharmacopoeial Convention. Monographs for drug substances, dosage forms and compounded preparations are featured in the USP. Excipient monographs are in the NF. The U.S. FDA designates the USP-NF as official compendia.
- JPis the Japanese Pharmacopoeia issued by the Pharmaceuticals and Medical Devices Agency (PMDA), working together with the Ministry of Health, Labour and Welfare of Japan.
DIN
DIN (Deutsches Institüt für Normung) is the non-profit German institute for Standardisation, whose main task is to develop technical rules for the society as a whole. By agreement with the German Federal Government, DIN is the acknowledged national standards body. A Scharlau product, which complies with any of the DIN standards will specify the appropriate DIN number/numbers in its description.
ISO/ACS
ISO 6353 specifies the general test methods for verifying the compliance of a reagent for chemical analysis with the specifications given in this international standard. The description of our products containing ISO means that the reagent meets the specifications and test methods described in this standard.
The American Chemical Society (ACS) Committee on Analytical Reagents sets the specifications for most chemicals used in analytical testing. ACS is a congressionally chartered independent membership organisation. Part of the analytical reagents range supplied by Scharlab are compliant with these specifications and this is stated in the product description.
ASTM
ASTM, formerly known as the American Society for Testing and Materials, develops and delivers international voluntary consensus standards, including test methods, specifications, guidelines and practices that support industries and governments worldwide. When a Scharlau product contains ASTM in its description, this indicates that it complies with the requirements of this standard.
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