Introduction to Chemical Risk Assessment (CRA)

In this article, we will give you an introduction to chemical risk assessment. We will focus on EU REACH regulation and industrial chemicals. 

If you have no chemistry, toxiclogy or eco-toxicology background, please start with following parts first.

• Chemical risk assessment basics part 1: Physico-chemical properties
• Chemical risk assessment basics part 2: Ecotoxicology and e-fate studies
• Chemical risk assessment basics part 3: Toxicology studies
• Chemical risk assessment basics part 4: Overview of chemical risk assessment
• Chemical risk assessment basics part 5: Overview of toxicological dose descriptors
• Chemical risk assessment basics part 6: How to calculate derived no-effect level
• Chemical risk assessment basics part 7: How to derive predicted no-effect concentration

Perfluorooctane sulfonic acid and its derivatives (PFOS)

Perfluorooctane sulfonic acid and its derivatives (PFOS) is a persistent organic pollutants (POP) and was included to the Annex B of the Stockholm Convention on Persistent Organic Pollutants.  PFOS is persistent, bioaccumulative and toxic to mammalian species.  PFOS is widely used as surface treatment agents for textiles, leather products, paper, furniture and carpets for its excellent waterproofing and oil-resistance performance.

PFOS and REACH Annex XVII

PFOS was originally included in REACH annex xvii restricted substances list . After PFOS was added to the Annex B of the Stockholm Convention in 2009, the European Commission removed PFOS from REACH annex xvii and added it to the annex I of the Regulation (EC) No 850/2004 of the European Parliament and of the Council on persistent organic pollutants. PFOS is now regulated as a persistent organic pollutant (POP) in EU.  Its restriction conditions (see table below) are set by COMMISSION REGULATION (EU) No 757/2010 amending the annex I of the Regulation (EC) No 850/2004 on POPs.

Product	Limit
Substances or preparations	The concentration of PFOS <=10 mg/kg
Semi-finished products or articles, or parts	The concentration of PFOS <0.1 % by weight calculated with reference to the mass of structurally or micro-structurally distinct parts that contain PFOS.
Textiles or other coated materials	The amount of PFOS i<1 μg/m2 of the coated material.
Excepted uses:	Photoresists or anti reflective coatings for photolithography processes, photographic coatings, provided certain conditions are met.

Other restricted hazardous substances on REACH annex XVII include:

• Azocolourants and Azodyes (entry 43)
• Polycyclic-aromatic hydrocarbons (PAHs) (entry 50)
• Perfluorooctane sulfonic acid and its derivatives (PFOS) (entry 53, deleted in 2010 and subject to EU POPs regulation now.)
• Pthalates (entry 51 and 52)
• Cadmium and its compounds (entry 23)
• Nickel and its compounds (entry 27)
• Lead and its compounds (entry 63)
• Mercury and its compounds (entry 
• Chromium VI compounds (entry 47)
• Arsenic compounds (entry 19)
• Nonylphenol and nonylphenol ethoxylates (entry 46)
• Organostannic compounds (entry 20)
• Hazardous solvents (benzene, cyclohexane,triclorobenzene, chloroform, toluene, etc);
• CMR 1A/1B substances listed in the annex VI of CLP regulation (28, 29, 30)

Some substances are literally banned by REACH annex XVII. These substances include Polychlorinated terphenyls (PCTs),asbestos fibres, pentachlorophenol and and its salts and esters, and  monomethyl-tetrachlorodiphenyl methane. Many of them are persistent organic pollutants (POPs). A complete list of banned persistent organic pollutants under the Stockholm Convention can be accessed here. 

Reference:

Perfluorooctane sulfonic acid and its derivatives (PFOS)

List of GHS Regulations, GHS Standards and GHS Resources 2016

When authorities adopt GHS for their own chemical hazard communication system, they often issue their own GHS regulations or GHS standards. In this article, we have summarized the latest list of GHS-related regulations, standards and resources with an aim to help you quickly find labeling and SDS requirements in different jurisdictions.

List of GHS Regulations, GHS Standards and GHS Resources 2016
GHS classification list
GHS classification criteria

Chemical Risk Assessment Basics: Toxicology

Toxicology is defined as the study of the adverse effects of chemicals or physical agents on living organisms. The following toxicology studies are often used for hazard assessment and human health risk assessment. Please click each toxicological endpoint for detailed info. 

• Acute toxicity (oral, inhalation, dermal)
• Skin and eye irritation
• Sensitization (skin, respiratory)
• Repeated dose toxicity (28d, 90d and chronic)
• Mutagenicity and genotoxicity
• Reproductive and developmental toxicity
• Carcinogenicity
• Toxicokinetics

Chemical Risk Assessment Basics: Toxicology

Chemical Risk Assessment Basics: Ecotoxicology and Environmental Fate

The following eco-toxicology and environmental fate studies are often used for GHS hazard classification and environmental risk assessment. They are very good summaries. 

• Aquatic toxicity (algae, daphina, fish)
• Degradation (biotic and abiotic)
• Bio-accumulation
• Terrestrial toxicity (earthworm, bird, bee, etc)
• Soil Adsorption Coefficient (Kd/Koc)

Chemical Risk Assessment Basics: Ecotoxicology and Environmental Fate

Disclosure of Confidential Business Info in SDSs 2016

GHS has also set a few general principles for the disclosure of confidential business info (CBI) in SDSs and on labels:

• CBI claims should be limited to the names of substances and their concentrations in mixtures;
• Where CBI has been withheld, the SDS and the label shall indicate;
• CBI should be disclosed to competent authority upon request.

In some region or countries, withholding confidential business info in SDSs or labels even requires prior approval from local competent authorities. In this article, we have summarized the information disclosure requirements in major countries that have adopted GHS.

GHS and Disclosure of Confidential Business Info in SDSs 2016

Endocrine Disruptors Regulations and Lists in Japan

Japan has been very active in investigating endocrine disruptors for a decade. In 1998, the Ministry of Environment Protection (MEP) started Strategic Programs on Environmental Endocrine Disruptors (SPEED) with a focus on screening of environmental endocrine disruptors. Under the programme, officials prioritised 67 suspected endocrine disrupters for further investigation. In November 2000 officials revised the list down to 65 chemicals.



Read more

Endocrine Disruptors Regulations and Lists in Japan

http://www.chemsafetypro.com/Topics/EU/Endocrine_Disruptors_Regulations_and_Lists_in_EU.html

http://www.chemsafetypro.com/Topics/China/Endocrine_Disruptors_Regulations_and_Lists_in_China.html

http://www.chemsafetypro.com/Topics/USA/Endocrine_Disruptor_Regulations_and_Lists_in_USA.html

Turkish Chemical Substance Inventory

Turkish chemical substance inventory is a list of chemical substances submitted by chemical manufacturers and importers under the Regulation on Inventory and Control of Chemicals (CICR).

How to Download Turkey Chemical Substance Inventory

In December 2011, the Turkish Ministry of Environment and Urban Planning (MoEUP) published the chemical substance inventory on their website in two parts:

• 2,888 substances manufactured or imported ≥1 t/y and <1000 t/y (download);
• 597 substances manufactured or imported at 1000t/y and above (HPV substances (download);

Please note that <1t/y chemical substances do not need to be listed in the inventory.

- See more at: Turkish Chemical Substance Inventory

GHS Classification List 2016

Many countries or authorities have published their own GHS classification lists for common chemical substances to help chemical companies comply with local GHS regulations, prepare safety data sheets and labels. The GHS classifications can be mandatory or non-mandatory (recommended classification).

In this article, we have summarized GHS classification lists in major countries in 2016 and how to access them.

GHS Classification List in EU

• List: Annex VI to the EU CLP Regulation;
• No. of substances: ~7,000;
• Published by: European Chemicals Agency;
• Mandatory or advisory: mandatory;
• How to access: ECHA’s C&L Inventory;

Please note that there are a few very important factors to consider when using the compulsory classifications listed in the annex VI to CLP.

Read more about the annex VI to CLP....

GHS Classification List in China

• List: Catalogue of Hazardous Chemicals (2015);
• No. of substances: ~2,828;
• Published by: State Administration of Work Safety (SAWS);
• Mandatory or advisory: mandatory;
• Chinese version: download;
• English version: Please contact us. Free to Chemical Watch subscribers.

- See more at: 

GHS Classification List 2016

How to Find a METI Number for a Substance

A METI number (usually in the format x-xxxx) is the registration number of a substance in the CSCL inventory of existing chemicals (ENCS). A substance that does not have a METI number (also known as Class reference number) will be regarded as a new substance in Japan and require notification under CSCL. METI numbers are also required for displaying composition info in the section 3 of SDSs in Japan.

It is not easy to search ENCS on CHRIP to get a METI number because ENCS listings are not based on CAS numbers. Each ENCS listing identified by one METI number may cover a number of similar substances. If you could not find a METI number on CHRIP or J-check, that does not mean your substance is new.

In this article, we will show you how to find a METI number for a substance with mineral oil as an example. If you are unfamiliar with the Japanese inventory of existing and new chemical substances (Japan ENCS) or CHRIP, please click here.

How to find a METI Number for White Mineral Oil?

White mineral oil (petroleum) (CAS 8042-47-5) is a very common chemical substance used in in a wide variety of industrial, professional and consumer applications like pharmaceuticals, cosmetics and food processing.

Assuming that you now need to check its inventory status in Japan and prepare SDSs, normally you will go to CHRIP or J-CHECK and search the ENCS by keyword (mineral oil) or by CAS number. In this case, this is what you will get.

- See more at: 
How to Find a METI Number for a Substance

GHS and Disclosure of Confidential Business Info in SDSs

GHS has given different competent authorities capabilities to make their own provisions to protect confidential business info in SDSs or on labels as along as such provisions do not compromise the health and the safety of workers and consumers. GHS has also set a few general principles for the disclosure of confidential business info (CBI) in SDSs and on labels:

• CBI claims should be limited to the names of substances and their concentrations in mixtures;
• Where CBI has been withheld, the SDS and the label shall indicate;
• CBI should be disclosed to competent authority upon request.

In some region or countries, withholding confidential business info in SDSs or labels even requires prior approval from local competent authorities. In this article, we have summarized the information disclosure requirements in major countries that have adopted GHS.

EU

In EU, essentially all hazardous substances must be declared in the safety data sheets (SDSs) if their concentrations exceed certain cut-off value (usually, 0.1% or 1% depending on hazards). Usually non-hazardous constituents do not need to be disclosed. However, non-hazardous substances must also be disclosed if there are union workplace exposure limits or if they belong to PBT substances. When disclosing composition info in SDSs, substance identifiers (CAS number or EC number), substance names as well as concentration or concentration ranges must be provided. If the concentration range is used, the classification derived for the particular concentration range should be based on the highest concentration in the range quoted.

Companies who are concerned about disclosing the full composition of a mixture in safety data sheets (SDSs) or on product labels can request the use of an alternative chemical name for a hazardous substance to protect their trade secrets. The request must be submitted to European Chemicals Agency (ECHA). A fee also needs to be paid in accordance with EU CLP regulation.

Reference

GHS and Disclosure of Confidential Business Info in SDSs