by Steve Schulte
The Enforcement Forum, according to Regulation European Commission (EC) 1907/2006, was established under ECHA (European Chemicals Agency) to identify enforcement strategies, as well as best practice in enforcement of the CLP (Classification Labelling & Packaging) requirements.
The Enforcement Forum recently agreed on a project which will coordinate inspectors from 15 member states to inspect packages of hazardous substances and mixtures intended for consumers. Specifically, they will be focusing on child resistant closures, the requirements of which exist under the Dangerous Goods and Preparations Directives and the CLP Regulation.
Products the inspectors will focus on are such items as lighter fluids, disinfectants, laundry products and drain cleaners. The inspections will be done at Distributors, re-packers, downstream users including retail markets and it may also include the Manufacturers of such hazardous substances and mixtures.
The inspections will take place from July 2015 through December 2015. A final report of the results of the inspection is expected to be published in June 2016.
by Safia Korati
REACH & CLP
The European REACH Regulation No. 1907/2006 aims for a high level of protection of human health and the environment, including promoting alternative methods for assessment of hazards of substances, as well as free circulation of chemicals in the European market, while enhancing competitiveness and innovation. REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals. It entered into force on June 1, 2007.
The CLP Regulation No. 1272/2008 ensures that the hazards presented by chemicals are clearly communicated to workers and consumers in the European Union through classification and labelling of chemicals. CLP stands for Classification, Labelling and Packaging.
Before placing chemicals on the market, industry must establish the potential risks to human health and the environment of substances and mixtures, classifying them in line with the identified hazards. Hazardous chemicals must be labelled according to a standardised system so that workers and consumers know about their effects before they handle them.
The CLP Regulation entered into force in January 2009, and the method of classifying and labelling chemicals it introduced is based on the United Nations' Globally Harmonised System (GHS). Over time, it replaces two previous pieces of legislation, the Dangerous Substances Directive (DSD) and the Dangerous Preparations Directive (DPD). There is a transition period until 2015.
Communication with suppliers: SDSs (REACH Annex II)
Safety data sheets (SDS) are the main tool for ensuring that suppliers communicate enough information along the supply chain to allow safe use of their substances and mixtures.
The requirements for the compilation of the SDS are specified in Annex II of REACH. SDSs include information about the properties of the substance (or mixture), its hazards and instructions for handling, disposal and transport and also first-aid, fire-fighting and exposure control measures. This information can be found in the main body of the SDS or in the annexed exposure scenarios (where applicable).
1 June 2015: Application of CLP for mixtures and Update of the SDSs (REACH Annex II)
From June 2, 2015, the CLP regulation is applicable for mixtures and consequently the requirements for SDSs in Annex II to REACH have been adapted. With the application of the CLP regulation for mixtures, the Section 3.2 Mixtures has been updated accordingly.
What is new? Mixtures are now classified according to the concentration limit values set in the Annex I of the CLP Regulation. Specifically, this Annex I contains a table of the hazard classes, the hazard categories and the concentration limits for which substance(s) shall be listed as a substance in a mixture. This table has been added in the amended version of REACH (Annex II).
What is the consequence for the supplier? It has to be checked if an update of the SDS is needed regarding this entry into force of the CLP Regulation for mixtures. However, it is important to note that the SDSs provided to any recipient before June 1, 2015 may continue to be used and need not comply with the amended Annex II until May 31, 2017.
More information on the REACH and CLP Regulations can be found at:
More information on the amended version of REACH can be found at:
by Susana Planas MunGavin
On May 30, 2015, the Ministry of Justice of Spain published Order JUS/992/2015 of May 29, 2015, amending Order JUS/836/2013, of May 7, 2013 establishing the procedure for notifying additions, deletions and modifications of toxicological information to the register of chemical products administered by the Toxicological Information Service of the National Institute of Toxicology and Forensic Sciences and concerning the settlement of the fee provided for in Law 10/2012, of 20 November 2012, regulating certain fees set by the Justice Administration and the National Institute of Toxicology and Forensic Sciences.
The Toxicological Information Service (Servicio de Información Toxicológica -SIT) of the National Toxicological and Forensic Science Institute (Instituto Nacional de Toxicología y Ciencias Forenses - INTCF) is the appointed poison centre in Spain.
This national regulatory framework further implements Article 45.1 of EU Regulation (EC) No 1272/2008 on the classification, labelling and packaging of substances and mixtures (CLP Regulation).
Prior to placing a hazardous mixture on the market for the first time or in the event of changing its composition, the manufacturer, importer or supplier responsible for placing the mixture on the market must provide the corresponding toxicological information to the INTCF. This information is aimed at identifying the necessary preventive and protection measures in the case of an emergency intoxication and in the event an emergency health response is required to be provided to the end user of the product.
Ministerial Order JUS/992/2015 establishes a transitional period which started on June 1, 2015 for importers and downstream users of hazardous mixtures to be able to notify Spain’s National Poison Centre about the chemical composition of hazardous mixtures placed on the market.
The extended deadlines apply to companies placing on the market in Spain any of the following classified hazardous mixtures intended for professional use only, assigned with the hazardous categories and the CLP Hazardous Statement codes as specified below:
- By January 1, 2016:
- Acute toxic mixtures - categories 1, 2 and 3 (oral, dermal and inhalation) (H300/H301/H310/H311/H330/H331)
- Systemic toxicity: STOT Single Exposure and Repeated Exposure – categories 1 and 2 (H370/H371/H372/H373)
- Skin corrosion and serious eye damage – category 1 (H314/H318)
- Carcinogenic, Mutagenic and Toxic to Reproduction (CMR) categories 1A, 1B and 2 (H340/H341/H350/H351/H360/H361)
- Skin and respiratory sensitisers – category 1 (H317/H334)
- By June 1, 2017: All other hazardous mixtures affected by Article 45 of the CLP Regulation.
The SIT is the authority responsible for maintaining a register of all notified mixtures. As provided under Article 8.1 of Ministerial Order JUS/836/2013, the notification must be accompanied with the following documents:
- A toxicological information sheet
- A copy of the label in Spanish as provided on the mixture when placed on the market
- A copy of the Safety Data Sheet (SDS)
The notification of hazardous composition is to be provided in Excel format. It is available on-line, in Spanish, together with further guidance documents at:
The INTCF contact details are as follows:
INSTITUO NACIONAL DE TOXICOLOGIA Y CIENCIAS FORENSES
Servicio de Información Toxicológica. Documentación
c/ José Echegaray, 4
28232 Las Rozas de Madrid
NOTE: Only those companies that do not currently display the 24-hour SIT emergency telephone number (915 620 420) on the SDSs (section 1.4) or that do not display it on the label of the hazardous mixtures placed on the market may benefit from the extended notification deadlines. However, it should be noted that any company placing a hazardous mixture on the market, regardless of its hazardous composition, may voluntarily submit toxicological information to the poison center of Spain.
The full text of Order JUS/992/2015 is available on-line, in Spanish, at: http://www.boe.es/boe/dias/2015/05/30/pdfs/BOE-A-2015-5950.pdf
The full text of Order JUS/836/2013 is available on-line, in Spanish, at: http://www.boe.es/boe/dias/2013/05/16/pdfs/BOE-A-2013-5127.pdf
by John J. Kowalski, CHMM
Among the most recent Environmental Protection Agency (EPA) actions under the Toxic Substances Control Act (TSCA) are the following:
On March 25, 2015, EPA published a notice announcing its receipt of test data submitted pursuant to a test rule codified at 40 CFR 799.5087 for 1,3-Propanediol, 2,2-bis[(nitrooxy)methyl]-, dinitrate (ester), CAS Registry Number (CAS RN) 78-11-5. The notice provided the uses of the subject chemical and the nature of the test data received, as required under TSCA Section 4(d).
On March 30, 2015, EPA published a final rule to remove six substances from the list of chemical substances that are partially exempt from reporting additional information under the Chemical Data Reporting (CDR) rule. The substances in question were added to the list by a direct final rule that the Agency published on January 27, 2015.
On April 3, 2015, EPA published a notice of receipt of premanufacture notices (PMNs) and notices of commencement of manufacture or import (NOCs). This notice covered the period from February 2, 2015 to February 27, 2015. It reported the receipt of 50 PMNs and 33 NOCs.
On April 6, 2015, EPA published a proposed rule under TSCA Section 8(a) to establish reporting and recordkeeping requirements for certain chemical substances when manufactured or processed at the nanoscale. See our previous blog article, “EPA Proposes New Requirements for Nanoscale Materials,” dated 13 April 2015, regarding the proposed rule.
On April 9, 2015, EPA published a proposed rule to amend the significant new use rules (SNURs) for 24 chemical substances which were the subject of PMNs. This action would amend the SNURs to allow certain uses without requiring a significant new use notice (SNUN) and would extend SNUN requirements to certain additional uses.
On April 14, 2015, EPA published a notice announcing its receipt of test data submitted pursuant to test rules codified at 40 CFR 799.5087 and 40 CFR 799.5089 for Methanone, diphenyl- (CAS RN 119-61-9) and Ethane, 1,1′-oxybis[2-chloro- (CAS RN 111-44-4) respectively. The notice provided the uses of the subject chemicals and the nature of the test data received, as required under TSCA Section 4(d).
On April 22, 2015, EPA published a notice of receipt of PMNs, test marketing exemption (TME) applications, and NOCs. This notice covered the period from March 1, 2015 to March 31, 2015. It reported the receipt of 51 PMNs, one TME application, and 25 NOCs.
On May 1, 2015, EPA published a notice to correct omissions in the notice that it published on April 14, 2015 announcing its receipt of test data submitted pursuant to test rules codified at 40 CFR 799.5087 and 40 CFR 799.5089.
On May 8, 2015, EPA promulgated SNURs for 25 chemical substances which were the subject of PMNs. Nine of these chemical substances are subject to TSCA section 5(e) consent orders. This action requires persons who intend to manufacture, import, or process any of these 25 chemical substances for an activity that is designated as a significant new use by these rules to notify the Agency at least 90 days before commencing that activity. According to EPA, the required notification will provide the Agency with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs.
Also on May 8, 2015, EPA announced a public meeting on the proposed rule for nanoscale materials. See our previous blog article, “EPA Schedules Public Meeting on Proposed Rule for Nanoscale Materials,” dated 19 May 2015.
On May 21, 2015, EPA published a notice announcing its receipt of test data submitted pursuant to test rules codified at 40 CFR 799.5089 for 2-Butenedioic acid (2E)-, di-C8-18-alkyl esters (CAS RN 68610-90-2) and Phenol, 2,4-bis(1-methyl-1-phenylethyl)-6-[2-(2-nitrophenyl)diazenyl]- (CAS RN 70693-50-4) respectively. The notice provided the uses of the subject chemicals and the nature of the test data received, as required under TSCA Section 4(d).
On June 2, 2015, EPA published a notice of receipt of PMNs and NOCs. This notice covered the period from April 1, 2015 to April 29, 2015. It reported the receipt of 63 PMNs, and 22 NOCs.
Environmental Protection Agency. “Receipt of Test Data Under the Toxic Substances Control Act.” Federal Register 80 (25 March 2015): 15787-15788. http://www.gpo.gov/fdsys/pkg/FR-2015-03-25/pdf/2015-06873.pdf
Environmental Protection Agency. “Withdrawal of Partial Exemption for Certain Chemical Substances.” Federal Register 80 (30 March 2015): 16576-16577. http://www.gpo.gov/fdsys/pkg/FR-2015-03-30/pdf/2015-06933.pdf
Environmental Protection Agency. “Certain New Chemicals; Receipt and Status Information.” Federal Register 80 (3 April 2015): 18227-18232. http://www.gpo.gov/fdsys/pkg/FR-2015-04-03/pdf/2015-07495.pdf
Environmental Protection Agency. “Chemical Substances When Manufactured or Processed as Nanoscale Materials; TSCA Reporting and Recordkeeping Requirements.” Federal Register 80 (6 April 2015): 18330-18342. http://www.gpo.gov/fdsys/pkg/FR-2015-04-06/pdf/2015-07497.pdf
Environmental Protection Agency. “Modification of Significant New Uses of Certain Chemical Substances.” Federal Register 80 (9 April 2015): 19037-19050. http://www.gpo.gov/fdsys/pkg/FR-2015-04-09/pdf/2015-08090.pdf
Environmental Protection Agency. “Receipt of Test Data Under the Toxic Substances Control Act.” Federal Register 80 (14 April 2015): 19982-19982. http://www.gpo.gov/fdsys/pkg/FR-2015-04-14/pdf/2015-08588.pdf
Environmental Protection Agency. “Certain New Chemicals; Receipt and Status Information.” Federal Register 80 (22 April 2015): 22512-22516. http://www.gpo.gov/fdsys/pkg/FR-2015-04-22/pdf/2015-09204.pdf
Environmental Protection Agency. “Receipt of Test Data Under the Toxic Substances Control Act.” Federal Register 80 (1 May 2015): 24918-24919. http://www.gpo.gov/fdsys/pkg/FR-2015-05-01/pdf/2015-10142.pdf
Environmental Protection Agency. “Significant New Use Rules on Certain Chemical Substances.” Federal Register 80 (8 May 2015): 26448-26460. http://www.gpo.gov/fdsys/pkg/FR-2015-05-08/pdf/2015-11166.pdf
Environmental Protection Agency. “Chemical Substances When Manufactured or Processed as Nanoscale Materials; TSCA Reporting and Recordkeeping Requirements; Notice of Public Meeting.” Federal Register 80 (8 May 2015): 26518-26519. http://www.gpo.gov/fdsys/pkg/FR-2015-05-08/pdf/2015-11215.pdf
Environmental Protection Agency. “Receipt of Test Data Under the Toxic Substances Control Act.” Federal Register 80 (21 May 2015): 29320-29321. http://www.gpo.gov/fdsys/pkg/FR-2015-05-21/pdf/2015-12336.pdf
Environmental Protection Agency. “Certain New Chemicals; Receipt and Status Information.” Federal Register 80 (2 June 2015): 31371-31375. http://www.gpo.gov/fdsys/pkg/FR-2015-06-02/pdf/2015-13418.pdf Key Words: