Friday, March 11, 2011

11% of tyres imported into EU are found to be non-compliant with PAHs requirements

The UK Environment Agency published a briefing letter based on a press release by ETRMA, the European Tyre and Rubber Manufacturers Agency on March 1st 2011. ETRMA have informed the UK agency that there have been possible breaches of the REACH restriction 50 concerning the levels of PAHs in extender oils and tyres.


On 1st January 2010, the restriction on PAHs came into force. According to this restriction, tyres, and treads for retreading, manufactured after the 1st January 2010 are banned from being placed on the market if they contain extender oils exceeding the following limits:

- More than 1 mg/kg (0.0001% by weight) Benzo(a)pyrene (BaP), or

- More than 10 mg/kg (0.001% by weight) of the sum of all PAHs listed in the restriction.


The information in the document ETRMA released is based on the first phase of its tyre testing program which was carried out over several months up to February 18th, 2011. They tested a comprehensive sample of all the tyres that are sold in the European Union for the presence of or high levels of PAHs oils.


While the tyres produced within the EU were found to be REACH Compliant, the main findings of the report reveal that, 11% of all those tested were non compliant. Furthermore, the report details that ETRMA completed its testing on a sample of 110 tyres produced under 45 brand names for sale in several of the largest tyre markets in the EU. Of the 45 brands surveyed, 12 tyres produced under 9 different brand names were found to be noncompliant, i.e. they were found to be containing PAH levels prohibited by REACH, and therefore are being sold illegally on the EU market.
Markings on the tyres indicated that they were produced in 16 countries, including 9 EU countries and 7 non-EU countries and from a total of 92 different production plants in these countries. The 12 non-compliant tyres were all imported.



“While eleven percent is a cause for concern, it does take on staggering dimensions when one considers the fact that some 100 million tyres are imported into the EU and placed on the market each year,” states Dr Francesco Gori President of ETRMA. “This may very well just be the tip of the iceberg.”


ETRMA now calls on the EU and National Authorities to intensify and broaden their own testing and enforcement activities.
Follow this link to read the full press release.
http://www.etrma.org/pdf/20110301%20-%20EN%20_ETRMA_Press%20release.pdf

Polycyclic aromatic hydrocarbons (PAHs)
PAHs are a group of over 100 different chemicals that are formed during the incomplete burning of coal, oil and gas, garbage, or other organic compounds. They are known for their carcinogenic, mutagenic and teratogenic properties and thus a restriction on some substances in this category has been imposed by various regulatory authorities.


So far, the EU has restricted 8 PAHs in tyres and extender oils, Germany has introduced mandatory PAHs testing for the GS certification process and the US EPA has restricted 18 PAHs in consumer goods. Thus, it is vital that industry is aware of the risks of their products containing PAHs and is knowledgeable on the required tests to ensure PAHs are not present in their products.


PAHs can be found in petrochemicals, rubber, plastics, lubricants, antirust oil, paints, leather and other products. Rubber and plastics are materials that have a high risk of containing PAHs, while tyres, electronics and toys are some of the consumer products most affected by the restriction of PAHs in the EU, Germany and the US.


ETRMA’s findings have serious implications if you are a manufacturer or importer, distributer or retailer of any tyre. Companies need to take action immediately to ensure that the tyres that they are supplying are compliant with the law.


All of the companies in a supply chain may be committing an offence if tyres are supplied that contain PAHs above the limits stated in the restriction.


It is your responsibility to ensure that the products your business supplies are compliant.

Tuesday, March 8, 2011

Malaysia - "Environmentally Hazardous Substances Notification and Registration " (EHSNR)

The Malaysian draft Regulation on "Environmentally Hazardous Substances Notification and Registration " (EHSNR) started on 2 January 2009 under the voluntary notification scheme and will be replaced by a mandatory programme when the regulation comes into force in 2011.

The draft regulation for EHSs notification and registration is now at the final stage and will be forwarded to the relevant government agencies, associations and NGOs for comments in the middle of March 2011. The purpose of the EHS notification and registration is to provide the necessary information to the Malaysian Government that will enable the Department of Environment (DOE) and other agencies involved in chemicals management to identify substances of concern in the country and make decisions about how to manage these substances in a safe and sound manner.

What is the definition of EHS?
An EHS is a substance that is included in the EHS Reference List,
or if not on the list, must be assigned a hazard category under the
GHS classification scheme, as implemented by the Department of
Occupational Safety and Health Malaysia.

Who shall submit EHS notifications?
Manufacturer of an EHS substance in Malaysia;
Importer of an EHS substance in Malaysia;

Non Malaysian exporters can appoint third party representatives (TPR) to submit external notifications on behalf of Malaysian importers. Please note that a malaysian legal entity is not required. Substances with volume above 0.1t/y might all be affected.


What information should be submitted during notification?
Chemical companies making the EHS notifications are required to submit a prescribed set of chemical data to the Department of Environment(DOE) in Malaysia.

There are two types of notification: basic notification and detailed notification. Each type of notification applies to different substances.

Basic notification for substances on EHS reference list
Only basic information needs to be provided. More specifically, the notifier must provide the following information to the DOE:

a) Substance Identification: (CAS number, EC number. or Code number);
b) Year of Notification;
c) EHS Occurrence: substance or substance present in a mixture or as constituents of finished product;
d) Concentration Range: the range in concentration of a given EHS is defined as the minimum and maximum concentrations, i.e. concentration interval, of the substance in raw materials or finished products;
e) Annual Tonnage of Substance:
f) Details of EHS Uses;
g) Country of export (if imported).

Detailed notification for substances not on EHS reference list
Basic notification data and the following data should be provided to DOE in Malaysia.


a) EHS Identification: Molecular Formula, Molecular Structure, Molecular Weight;
b) Physical and Chemical Properties: Physical State at 20C and 101.3 KPa, Colour, Odour, Melting Point, Boiling Point, Flash Point, Auto-Ignition Temperature, Vapour Pressure, Density, Water Solubility, Partition Coefficient in octanol /water (log Kow), Viscosity;
c) Physical Hazards: Explosivity, Flammability, Oxidizability, Self-Reactive, Pyrophoric, Self-Heating, Organic Peroxides, Corrosive to Metals, Gases Under Pressure, Water Activated Flammable Gases;
d) Hazards to Human Health;
e) Hazards to Aquatic Environment:Acute aquatic toxicity, 96 hr LC50, 48 hr EC50, 72 or 96 hr ErC50, Chronic aquatic toxicity, Ready biodegradable, Bioaccumulation, Log Kow

When is notification deadline?
Substances with volume above 100t/y shall be notified in 2011 and 2012. All substances that, under GHS classification, are assigned an aquatic toxicity classification of "chronic 1" (*) or are suspected or known human carcinogens, reproductive toxicants or mutagens (+) must also be notified during years 2011 and 2012.

How do I know if my substance is exempted or not?
Substances which fall into any of the categories below are totally exempted from the requirements of EHSNR.

The substances not included in the EHS Reference List and not classified as hazardous according to GHS criteria as outlined in CLASS regulation/guidance document;
The substances which are already regulated by other legislation and N&R schemes in Malaysia viz pesticides and pharmaceuticals;
The substances in naturally-occurring materials e.g. minerals, ores and ore concentrates as well as cement clinke;
Incidental/end-use reaction products;
Substances formed during the manufacture of an article;
Mixtures (but not mixture components) ;
Impurities and By-products;
Non-isolated intermediates i.e. chemical substances used to manufacture other chemical substances that are never separated from the mixture of other chemicals inside a closed system;
Contained site-limited intermediates;
Transported intermediates ;
Substances manufactured solely for export;
Substances used in research and development;
Substances produced for test marketing;
Substances in imported finished consumer products;
Substances produced in low volume (<0 .1="" annum="" br="" per="" tonnes="">Substances in mixture or products where the concentration of the substance is below 1 % (0.1 % for carcinogenic substances, substances toxic to reproduction, and category 1 and 2 mutagens).

Are there any sanctions for incompliance?Yes, the notification of EHS will be mandatory once the Regulation on notification of EHS is gazetted.

Regulations on the Classification, Labeling, Packaging of Chemicals and SDS in China – China GHS

China has fully implemented GHS for all hazardous substances and mixtures from 1 May 2011. Decree 591 requires manufacturers of hazardous chemicals to classify, label and package chemicals as well as prepare safety data sheets in accordance with relevant national standards. Decree 591 also prohibits distributors from selling hazardous chemicals without SDSs and labels. In addition, GHS SDSs and labels are required by new substance notification under MEP Order 7 and HazChem registration under SAWS Order 53.

Chemical classification criteria and the content and format of SDSs and labels are set by several compulsory national standards (prefixed with "GB") and recommended national standards (prefixed "GB/T") issued between 2008 and 2013. The table below summarizes the latest Chinese national standards that businesses need to follow to classify chemicals and prepare SDSs and labels.

Classification Standards & Building Blocks in China

In 2013, the Standardization Administration of the People's Republic of China (SAC) issued 28 compulsory chemical classification standards (GB 30000.2-2013 to GB 30000.29-2013 Safety rules for classification and labelling of chemicals) and each standard corresponds to one hazard class under GHS. Those standards are fully aligned with UN GHS Rev. 4 and have adopted all building blocks under UN GHS Rev. 4 including aspiration hazards and hazards to the ozone layer.
For those who are interested in knowing chemical classification criteria in China, they may directly refer to the English version of UN GHS Rev. 4 since GB 30000.2~29 are directly translated from UN GHS Rev. 4.

Compulsory GHS Classification in China

For chemicals listed in the Catalogue of Hazardous Chemicals, the State Administration of Work Safety (SAWS) is planning to issue a guidance document on harmonized chemical classifications of those chemicals. Once this guidance is issued, companies must use the classifications given in the guidance or more severe classification to classify their chemicals and prepare SDSs and labels.

Requirements on Chinese GHS Labels

GB 15258-2009 General rules for preparation of precautionary label for chemicals has set detailed requirements on the content and format of chemical labels. China has adopted standard GHS label elements(see example given below) and set additional requirements on language, 24h emergency telephone number, and sizes, etc.

Related GHS Info & Resources


Registration of the Import/Export of Toxic Chemicals in China

China’s existing chemicals management regulations only cover toxic chemicals, which are listed in the “List of toxic chemicals severely restricted to be imported into or exported from People Republic of China” The Chinese government released the Provisions on the First Import of Chemicals and the Import and Export of Toxic Chemicals in 1994, which was amended several times years later. Companies which deal with import and/or export of those toxic chemicals need to register with the Chemical Registration Centre (CRC) and apply for relevant registration certificates or custom clearance notification.

Note 2015:  The registration of restricted toxic chemicals has been replaced by China MEP Order 22 issued in 2013. More info can be found in MEP order 22.

Foreign companies which export toxic chemicals (as listed) to China will need to apply for a Registration Certificate. One Registration Certificate is issued for only one type of toxic chemical, to only one foreign company with only one China domestic company as its trader; and each Registration Certificate is issued with a quantity limit and with a valid period of two years.

For every batch of goods introduced to China, the importer (China domestic company) shall apply for an Import Clearance Notification by providing a copy of the Registration Certificate obtained from its contract partner, i.e. a foreign company which exports goods to China.

Domestic companies shall apply for Export Clearance Notification for every batch of toxic chemicals before exporting those goods to other countries.

Application of a Registration Certificate
1. The foreign exporter shall prepare the following materials and submit those documents to CRC:

- Application form;
- Business contract or agreement (reflecting two years' trade information);
- Duplicate copy of Verification of Import/Export Right.


2. Registration fee $10,000 per certificate or equivalent RMB is acceptable.


3. CRC will conduct completeness and correctness check within 5 days from the receipt of all documents and application fee. A reference number will be allocated for each application and preliminary feedback will be given on CRC’s website.


4. CRC will review each application and provide the results from their basic processing to the SEPA. Once the application is approved by SEPA, a “Registration Certificate” will be issued by SEPA and distributed by CRC. If the application is denied, the applicants will be duly notified by CRC. The whole processing period is within 30 working days on the arrival of the completed application materials.



Application of Import Clearance Notification
1. The domestic importers shall submit following materials to CRC:

Application form;
Duplicate copy of “Registration certificate” obtained from the foreign business partner;
Original contract for every batch of goods;
Document to communicate information to downstream users;
Verification of Import/Export Right;


2. CRC will conduct completeness and correctness check within 5 days from the receipt of all documents. A reference number will be allocated for each application and preliminary feedback will be given on the CRC’s website.



3. CRC will review each application and provide details on the outcome of their basic processing to the SEPA. Once the application is approved by SEPA, “Import Clearance Notification” will be issued by SEPA and distributed by CRC. If the application is denied, the applicants will be duly notified by CRC. The whole processing period lasts no more than 20 working days from the arrival of the completed application materials.


Application of Export Clearance Notification
1. The domestic exporters shall prepare following materials for applying for Export Clearance Notification

- Application form;
- Original contract for every batch of goods;
- Document to communicate information to downstream users;
- Verification of Import/Export Right;


2. Special rules apply to some toxic chemicals, for example, arsenic and its compound products, sodium cyanide, mercury and it compound products, etc.


Rule (1): The supplier of Arsenic and its compound products should have been approved by local Environmental Protection Bureau to produce these products.


Rule (2): For DDT, Hexachlorobenzene, Sodium cyanide, Tetramethyllead, Tetraethyllead, Pentachlorophenol, Chlordane, Oxirane, and Hexachlorocycloh (BHC), Rule (1) is also applied. Pursuant to the “Prior Informed Consent (PIC) procedure”, a “Response Letter” from the import country’s designed national authority (DNA) is compulsory for the application.


Rule (3): Rule (1), (2) are also applied to Mercury and its compound products. In addition, the applicant should provide an “Opinion Letter” issued by local Environmental Protection Bureau.


3. CRC will conduct completeness and correctness check within 5 days of the receipt of all documents. A reference number will be allocated for each application and preliminary feedback will be given on CRC’s website.


4. CRC will review each application and give basic processing opinion to the SEPA. Once the application is approved by SEPA, “Export Clearance Notification” will be issued by SEPA and distributed by CRC. Otherwise, the applicants will be duly notified by CRC if the application is denied. The whole processing period lasts no more than 20 work days from the arrival of the completed application materials.