Global Regulatory Update for July 2013
NICNAS Changes Registration Structure For Industrial Chemicals: The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) announced that beginning September 1, 2013, it will have four levels of registration, with a new level for commercial introducers (manufacturers or importers) of relevant industrial chemicals with an annual value of less than $100,000. The change means current registrants at the lower tier of registration (under $500,000) will be split into two levels: those introducing relevant industrial chemicals with an annual value of less than $100,000 (Level A) and those introducing an annual value of $100,000 or more (Level B). The illustration below shows the four levels of registration:
NICNAS states that it will post registration renewal packs to all NICNAS registrants in mid-July 2013. Registrants should contact NICNAS if they do not receive a renewal pack by July 22, 2013. Late penalties will apply to any registration renewal received after August 31, 2013. More information is available online.
Health Canada Seeks Comments On Proposal To Implement GHS In Canada: Health Canada published a notice in the June 29, 2013, Canada Gazette seeking written comments on a proposal to repeal and replace the Controlled Products Regulations with new regulations to be entitled the Hazardous Products Regulations. The new regulations would implement the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) hazard classification criteria and hazard communication elements and, to the maximum extent possible, be in alignment with Occupational Safety and Health Administration’s (OSHA) Hazard Communication Standard. The proposed Hazardous Products Regulations would implement changes in five broad areas:
- The manner of establishing the classification of hazardous products;
- Classification of physical hazards;
- Classification of health hazards;
- Hazard communication and other requirements; and
Canada states that the notice is an opportunity for the public to provide early comments and input before Canada prepublishes the regulations in the Canada Gazette. Canada notices that the prepublication process will provide an additional opportunity for public comment on the proposed regulations. Comments are due September 15, 2013. More information is available online.
EUROPEAN UNION (EU)
ECHA Seeks Comment On Draft Five-Year Strategic Plan: The European Chemicals Agency (ECHA) announced on May 28, 2013, a public consultation on its first five-year strategic plan. ECHA states that the draft Multi-Annual Work Programme 2014-2018 is structured around its four long-term strategic goals: improving the quality of information on chemicals; making best use of that information for risk management and control; addressing scientific challenges; and working efficiently and effectively on tasks coming from the Biocidal Products and Prior Informed Consent Procedure (PIC) Regulations. ECHA invites individuals, civil society, and industry organizations to provide comments from their area of interest and expertise. ECHA states that the ECHA Management Board will be asked to adopt the final version at its meeting in September 2013. More information is available online.
EC Begins Consultation On OSH Policy Framework: On May 31, 2013, the European Commission (EC) began a public consultation on the new European Union (EU) occupational safety and health (OSH) policy framework. According to the EC, the main purpose of the consultation is to obtain comments on the results of the evaluation of the European Strategy on Safety and Health at Work 2007-2012. The EC states that it particularly seeks comments from Member State public authorities, social partner organizations, and stakeholders and experts with an interest in the area of occupational safety and health. Comments are due August 26, 2013. More information is available online.
Harmonized Classifications According To The DSD Now Available In The C&L Inventory: On June 11, 2013, ECHA announced that the classification and labeling (C&L) of all harmonized substances included on Annex VI to the Classification, Labeling and Packaging (CLP) Regulation according to the criteria set out in the previous Dangerous Substances Directive (DSD) will now be available in the C&L Inventory. ECHA states that this addition is intended to help users who still classify and label their mixtures according to the DSD. Although fully replaced by the CLP Regulation for substances, the DSD criteria can still be applied to mixtures until June 2015. The categorization of harmonized substances according to the Seveso II Directive is also included. More information is available online.
EC Adopts Biocides Fee Regulation: The EC adopted the biocides fee regulation, which it published in the June 19, 2013, issue of the Official Journal of the European Union. The regulation authorizes ECHA to levy fees concerning the making available on the market and use of biocidal products. The regulation is available online.
ECHA Adds Six SVHCs To Candidate List: ECHA announced on June 20, 2013, that the Member State Committee unanimously agreed to identify six new substances as substances of very high concern (SVHC). The six substances added to the Candidate List for authorization are cadmium; cadmium oxide; ammonium pentadecafluorooctanoate (APFO); pentadecafluorooctanoic acid (PFOA); dipentyl phthalate (DPP); and 4-nonylphenol, branched and linear, ethoxylated. More information is available online.
EC Begins Consultation On The REACH Annexes On Nanomaterials: On June 21, 2013, the EC began a consultation on the modification of the REACH regulation annexes on nanomaterials. According to the EC, the objective of the initiative is to provide further clarity on how nanomaterials are addressed. The EC states that REACH must ensure a high level of health, safety, and environmental protection, while also permitting access to innovative products and promoting innovation and competitiveness. The EC intends to provide clearer REACH requirements for nanomaterials to ensure that industry demonstrates safe use in the registration dossiers in accordance with REACH Article 1(1). The EC expects to propose a possible amendment of the REACH annexes in 2013. Any proposed amendment would be accompanied by an impact assessment. Comments are due September 13, 2013. More information is available online.
ECHA Begins Public Consultation On Inclusion Of New Substances To The Authorization List: On June 24, 2013, ECHA began a public consultation on its draft recommendation to add six substances to the Authorization List. Based on an assessment of the available information and initial consultation of the Member State Committee, ECHA intends to recommend the following substances: N,N-dimethylformamide (DMF); diazene-1,2-dicarboxamide (C,C’-azodi(formamide)) (ADCA); aluminosilicate refractory ceramic fibers (Al-RCF); zirconia aluminosilicate refractory ceramic fibers (Zr-RCF); bis(pentabromophenyl) ether (decabromodiphenyl ether) (DecaBDE); and 4-(1,1,3,3-tetramethylbutyl)phenol, ethoxylated (4-tert-Octylphenol ethoxylates) (4-tert-OPnEO). ECHA states that the recommendation also specifies the proposed conditions to the authorization requirement for each substance. The conditions include the latest application and sunset dates and any specific exemptions of uses from the authorization requirement. Comments are due September 23, 2013. More information is available online.
ECHA Holds First Biocides Stakeholders’ Day: On June 25, 2013, ECHA held its first biocides stakeholders’ day, which included representatives from most EU Member States, Turkey, India, China, Canada, and the U.S. During the conference, ECHA explained the new processes and application opportunities for companies under the Biocidal Products Regulation. ECHA also presented the review program for active substances and practical implications of EU authorization. ECHA demonstrated how to use IUCLID version 5.5 to prepare biocides dossiers and the forthcoming new release of the Register for Biocidal Products, which is the tool for submitting these dossiers. Guest speakers explained the roles of the EC and the Member States under the new regulation and provided an industry perspective. ECHA published its updated biocides web section and the first biocides submission manual addressing the preparation of applications for active substances and biocidal products in IUCLID. According to ECHA, it will publish the “most essential guidance documents and other IT manuals essential for submitting dossiers from entry into operation” over the summer. More information, including a link to speaker presentations, is available online.
Croatia Joins EU As 28th Member State: Croatia became the 28th Member State of the EU on July, 1 2013. By joining the EU, and as part of the Accession Treaty, Croatia must abide with all the EU’s standards and rules, including REACH and Regulation (EC) No. 1272/2008 on the CLP.
The Accession Treaty allows Croatian manufacturers and importers a new pre-registration period, starting July 1, 2013, and ending January 1, 2014. Upon pre-registration, Croatian companies must declare that they are entitled to these pre-registration transitional measures to allow pre-registrations of ≥100 tonnes per annum to be submitted. The Accession Treaty states that the dates for the first and second registration deadline set out in REACH Article 23(1) and (2) must be 12 months from the date of accession. The following table outlines the Croatian REACH registration deadlines:
|Type of Substance||Registration Deadline|
|— Phase-in substances classified as carcinogenic, mutagenic or toxic to reproduction (CMR), category 1 or 2, in accordance with Directive 67/548/EEC, and manufactured or imported in quantities reaching one tonne or more per year.|
— Phase-in substances classified as very toxic to aquatic organisms that may cause long-term adverse effects in the aquatic environment (R50/53) in accordance with Directive 67/548/EEC and manufactured or imported in quantities reaching 100 tonnes or more per year.
— Phase-in substances manufactured or imported in quantities reaching 1,000 tonnes or more per year.
|July 1, 2014|
|Phase-in substances manufactured or imported in quantities reaching 100 tonnes or more per year.||July 1, 2014|
|Phase-in substances manufactured or imported in quantities reaching 1 tonne or more per year.||May 31, 2018|
Non-EU manufacturers that have appointed an Only Representatives (OR) and wish to address all EU imports under REACH must now consider product/substance exports made to Croatia. This will require the communication of any Croatian importers within the supply chain to be addressed in pre-registrations and/or registrations. The OR can communicate the relevant pre-registration or registration number to the Croatian legal entity to ensure its compliance. In turn, the Croatian imports per legal entity must communicate annual tonnage to the OR. If the additional tonnage results in an increase to a higher tonnage band, the pre-registration or registration should be updated accordingly.
With regards to CLP notification, at this time no transitional measures are in place. According to CLP Article 40, a CLP notification must be submitted within one month of the substance being placed on the market. This applies to Croatian legal entities; for all substances placed upon the market before July 1, 2013, a CLP notification must be submitted by August 1, 2013.
More information regarding the requirements of Croatian legal entities under REACH and CLP is available in ECHA’s Questions and Answers: For Croatian Companies Pre-registering and Registering under REACH guidance document, which is available online.
EU Member States Publish Guidance On SVHCs In Articles: Authorities responsible for REACH in Belgium, Denmark, France, Germany, Norway, and Sweden published a document entitled Guidance for Suppliers of Articles: The REACH duties to inform about Candidate List substances. The guidance document is intended to provide practical advice for suppliers of articles on how to carry out their legal duties to inform about contents of chemical substances on the Candidate List. The guidance includes the following shortlist “of some of the most important pieces of advice to remember”:
- If there is more than 0.1% w/w of a Candidate List substance in an article, information about this must be provided irrespective of the article being sold separately or included in an assembled article;
- The information will communicate where the substance is contained, if it is contained in an article within an assembled article, and can simply be passed down the supply chain;
- When accessing information from own suppliers it will help to use a probability approach. This enables focusing on the articles that most probably contain Candidate List substances, and on the substances most probably used in those articles;
- A stepwise work procedure may also help, particularly if the supplier deals with many and/or very complex articles;
- The information received needs to be validated, and where needed complemented via further questions to own suppliers, or even analyses;
- Cooperation within sectors will facilitate the work triggered by the REACH information duties, not the least to find out which substances may most probably be contained;
- It is crucial also to have good routines and tools for the work triggered by the REACH information duties. This benefit increases as more substances are added to the Candidate List. It also increases if the supplier deals with many and/or very complex articles;
- To have a general quality management system facilitates any work triggered by the REACH information duties, and is the single most important action to ensure workability; and
- It is crucial to observe closely the substances continuously added to the Candidate List, since the duty to inform customers enter into force immediately at listing.
The guidance document is available online.
ECHA Calls For Additional Information On The Use Of Cadmium And Cadmium Compounds: On July 4, 2013, ECHA called for additional information on the use of cadmium and cadmium compounds, in particular cadmium-based pigments in plastic materials, to assess the need for expanding the current restriction. According to ECHA, in response to its earlier call for evidence on the use of cadmium and cadmium compounds in plastics, it received information from only one company in the EU on how cadmium-based pigments are used in plastic materials. ECHA states that there are indications that other companies also use cadmium pigments in plastic materials in the EU, and an expansion of the restriction to the use of cadmium and its compounds could have an impact on these companies. ECHA invites anyone who could be affected by this possible expansion or who holds relevant information to provide comments before August 29, 2013, by completing an online questionnaire available on the ECHA website. ECHA notes that this information request “does not replace the public consultation should ECHA propose a restriction.” More information is available online.
EU And Industry Will Invest In Research And Innovation, Including Biobased Industries: The EC announced on July 10, 2013, that together with EU Member States and European industry, it will invest more than €22 billion over the next seven years in innovation for sectors that deliver high quality jobs. According to the EC, most of the investment will go to five Joint Technology Initiatives, which are public-private partnerships:
- Innovative Medicine 2: To develop next generation vaccines, medicines and treatments, such as new antibiotics;
- Fuel Cells and Hydrogen 2: To expand the use of clean and efficient technologies in transport, industry, and energy;
- Clean Sky 2: To develop cleaner, quieter aircraft with significantly less carbon dioxide emissions;
- Biobased Industries: To use renewable natural resources and innovative technologies for greener everyday products; and
- Electronic Components and Systems: To boost Europe’s electronics manufacturing capabilities.
More information is available online.
ECHA Posts Guidance Documents Concerning Biocides: On July 16, 2013, ECHA posted two new guidance documents applicable beginning September 1, 2013, which is when the Biocidal Products Regulation (BPR) will enter into operation. According to ECHA, the guidance on information requirements is intended to provide detailed and practical direction on the study data and other information that should be submitted when applying for active substance approval or authorization of biocidal products according to the BPR. ECHA notes that the guidance is derived from the Technical Notes for Guidance on Data Requirements under the former legislation — the Biocidal Products Directive (BPD). ECHA cautions users to be aware that the information required under the BPR is different from that which was required under the BPD. The Guidance on active substance suppliers explains the obligations for companies under BPR Article 95. It provides guidance on who has to submit the required information to ECHA, which information has to be submitted, and guidance on the regulatory consequences. ECHA states that it will release separate guidance documents later on the information requirements for substances of concern in the biocidal product, on micro-organisms, and on nanomaterials. More information is available online.
FDA Issues Circular Clarifying Oversight Of Industrial Chemicals: In a June 20, 2013, circular entitled “Deregulation of Bulk Industrial Chemicals Used as Raw Materials in Cosmetic Products and Household Products Considered as Urban Hazardous Substances,” the Food and Drug Administration (FDA) stated that it shall no longer regulate industrial chemicals for industrial use and intended for further processing as ingredients to manufacture or produce cosmetic products or preparation of household/urban hazardous substances (HUHS) falling within the definition of HUHS. It excluded household/urban pesticides, however. The circular advises establishments with existing FDA Licenses to Operate as Raw Material Manufacturer, Trader, or Distributor, or both, for Cosmetics and HUHSs and all market authorization holders of valid Certificate of Product Registrations not to renew their FDA authorizations. The circular notes that any establishments packaging and labeling industrial chemicals into consumer products must secure proper authorization, however. The circular took effect immediately. It is available online.
Legislature Passes Amendments To Labor Occupation and Safety Act: On June 18, 2013, the Legislative Yuan passed amendments to the Labor Occupation and Safety Act, including renaming it the Occupational Safety and Health (OSH) Act. According to the Council of Labor Affairs (CLA), key revisions related to chemicals management include:
- Manufacturers and importers must submit hazard and work risk assessment information and obtain approval for the registration of new chemicals prior to manufacture or import;
- To strengthen permitting management of listed controlled chemicals with carcinogenicity, special health hazards, major health risk, or acute hazards, the manufacturer, importer, or employer shall not manufacture, import, or provide to workers for handling such chemicals designated by the competent authority of the central government. The manufacturer, importer, or employer must submit relevant operation data for priority management chemicals;
- Manufacturers or importers, prior to providing hazardous chemicals to business units or the self-employed, must have labels and provide SDSs; and
- For hazardous chemicals, employers must assess their risks and implement management measures of control banding according to hazards, distribution, and handling amount of hazardous chemicals.
CLA states that it “will proactively develop supplementary regulations and related measures to ensure implementation of the Act.” As discussed below, the draft amendments to the Toxic Chemical Substances Control Act would also address new chemical substances. More information is available, in English, online.
Legislature Could Approve Amendments To The Toxic Chemical Substances Control Act In July: The legislative caucuses agreed on June 25, 2013, on a common draft of amendments to the Toxic Chemical Substances Control Act. The amendments would:
- Require enterprises to apply for registration prior to the manufacture or import of new chemicals. Based on data submitted to the Environmental Protection Agency, the Agency will classify the chemicals as candidates of Class 1, 2, 3, or 4 toxic chemicals. Chemicals classified in Classes 1, 2, 3, and 4 could be subject to bans, restrictions, or conditions on the use of the substance. In addition, for Class 4 chemicals, enterprises could be required to provide risk assessments and other related data.
- Impose fines of NT$200,000 to 2,000,000 on manufacturers or importers of a new chemical without registration. Enterprises violating the supplementary requirements for candidate toxic chemicals could be subject to fines of NT$100,000 to 500,000.
- Make registration information available to the public. The Environmental Protection Agency would have the authority to grant confidentiality for national defense or confidential business information (CBI) concerns upon application by the manufacturer or importer.
The opposition Democratic Progressive Party lawmakers proposed two resolutions. The first would authorize the Environmental Protection Agency to develop separate registration and evaluation requirements for nanomaterials. The second would request responsible government agencies to expand regulation to include articles containing potentially toxic chemicals. The Legislative Yuan is expected to pass the amendments after the second and third reading during the upcoming special session to be held in late July 2013.
Amendments To OSH Act Strengthen Management Of Outsourcing Hazardous Work: The Ministry of Employment and Labor (MOEL) announced that on June 12, 2013, it promulgated amendments to the OSH Act. Under the amendments, if a company contracts out harmful or hazardous work, it will be required to take greater responsibility for safety and health management. The amendments also strengthen employers’ responsibility for safety and health personnel, such as safety and health managers, safety managers, and health managers. According to MOEL, the amendments include the following provisions:
- Companies that contract out harmful or hazardous work will be obligated to provide harm and hazard information to their contractors and take action to correct violations committed by them. If a company fails to take the required measures in advance, including providing harm and hazard information to its contractor, it will be punished by imprisonment for up to one year or a fine not exceeding 10 million won. If a company takes no action against its contractor’s act of violating the OSH Act, it will be fined up to 5 million won.
- Employers’ responsibility for supervising the work of safety and health personnel will be strengthened. Currently, employers are considered to have fulfilled their duty as long as they have appointed or designated safety managers. In the future, punishment will be imposed on employers who have appointed or designated safety and health personnel, but fail to supervise or manage them. If a safety- and health-related employee is found to be performing only part of his duties, the employer will be punished. A person who violates this provision will be fined up to 5 million won.
- Under the amendments, the scope of those obliged to receive safety certification and the obligation to take protective measures will be expanded to include importers to ensure the safety of imported products. In addition, protective measures will have to be taken for every machine or instrument that has lugs on its operating parts, power transmission and speed control parts, or nip points on its rotating parts. A person who breaches this requirement will be banned from transferring, leasing, installing, and using such machines and instruments. A person who violates this provision will be punished by imprisonment for up to one year or a fine not exceeding 10 million won.
- The legal ground will be established to allow constructors to request changes to the design of a temporary structure. If the client firm fails to accept the constructor’s request for design change without any special reason, it will be fined up to 10 million won.
- A system of ordering an investigation on the harmfulness or hazardousness of chemicals will be introduced. If a chemical is suspected of causing serious health hazards, such as occupational cancer, its harmfulness and hazardousness will be “promptly investigated.” The amendment will make it possible to order a person who produces, imports, or uses chemicals other than new chemicals to investigate their harmfulness and hazardousness and to take action promptly to prevent health hazards for workers. A person who fails to submit the results of an investigation on the harmfulness and hazardousness of chemicals will be fined up to 3 million won. A person who fails to take necessary action to prevent health hazards for workers on the basis of the investigation results will be fined up to 10 million won.
The provisions prescribing employers’ responsibility for supervising the work of safety or health managers will enter into force on the date of promulgation, and the other provisions will take effect nine months after promulgation. More information is available, in English, online.
Thailand Proposes Combining Hazardous Substance Lists: Thailand has proposed combining its eight hazardous substance lists into a single list that would identify chemicals using both their Thai and English names. Six agencies currently regulate the hazardous substances lists: the Department of Industrial Works; FDA; the Department of Agriculture; the Department of Livestock Development; the Department of Fisheries; and the Department of Energy Business. Some of the lists are regulated by more than one agency. Once the lists have been combined, agencies will regulate separate sections. Hazardous substances would still be classified as four types. If a risk assessment report is required, it would be submitted to the Department of Industrial Works for consideration, and a permit would be issued before manufacturing, import, or use.
WORLD HEALTH ORGANIZATION (WHO)
WHO Launches New Chemical Risk Assessment Network: WHO announced on July 1, 2013, the launch of a network of risk assessment institutions intended to improve chemical risk assessment globally. According to WHO, the network will scale up action and facilitate sustainable interaction between institutions on chemical risk assessment. The network objectives are to:
- Provide a forum for scientific and technical exchange;
- Facilitate and contribute to capacity building;
- Promote best practices and the harmonization of methodologies;
- Assist in the identification of research needs and promote the application of new science in risk assessment practice;
- Assist in the identification of emerging risks to human health from chemicals;
- Share information about work programmes to avoid duplication of effort; and
- Upon request, assist WHO in the development of training and other materials in support of the above.
WHO invites institutions engaged in human health risk assessment of chemicals to become network participants. More information is available online.