Regulatory DevelopmentsFebruary 9, 2011
Both Turkey and South Korea are working to implement chemical management programs to comply with broader international initiatives. In December 2009, Turkey implemented new legislation concerning the classification, labeling, and packaging (CLP) of dangerous substances and preparations, and a regulation on safety data sheets (SDS) for dangerous substances and preparations. South Korea has initiated a process for the management of chemicals, with the objective of minimizing the harmful effects that substances have on human health and the environment. This memorandum provides an overview of these programs.
Although Turkey's Chemical Inventory Control Regulation has received much attention, on December 26, 2009, Turkey also implemented new chemical legislation concerning the CLP of dangerous substances and preparations and SDSs for dangerous substances and preparations. Both initiatives were given the same legal reference, 27092, and the Turkish Ministry of Environment and Forestry (MOEF) is managing each. The full text of the legislation is available in Turkish online.
CLP Regulation for Dangerous Substances and Preparations (27092)
Through the legislation, Turkey has in essence adopted the European legislation that governs the CLP of dangerous chemicals. As implemented by Turkey, the law is identical to the Dangerous Substances Directive (67/548/EEC) (DSD) and Dangerous Preparation Directive (1999/45/EC) (DPD), implemented by the European Commission. Implementation of CLP in Turkey will remain in place until 2012, which is when Turkey plans to implement the Global Harmonized System of Classification and Labeling of Chemicals (GHS). Until GHS is implemented, suppliers to entities located in Turkey must ensure that all labels conform to the requirements of the CLP legislation.
SDS Regulation for Dangerous Substances and Preparations (27092)
Turkey's rationale for implementing the SDS regulation is to standardize the format in which safety information is presented and thus to provide effective controls and supervision to mitigate against adverse effects on human health and to protect the environment. This will apply to any dangerous substance or dangerous preparation placed on the Turkish market. When classification is complete, the hazard information and control measures must be presented in a standard format, typically in an SDS. The regulation states that certain substances and preparations are exempt from being provided on an MSDS to the end user. Specifics are located within the regulation, however, exemptions seem to follow closely those allowed under the European Union's (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) legislation (EC 1907/2006).
The principles of SDS preparation are similar to those in Europe and the United States with a few nuances to consider.
Any manufacturer, importer, or distributor within Turkey who is responsible for placing a dangerous substance or dangerous preparation on the market must provide an SDS compliant with the regulation. A dangerous substance or preparation is one that is classified as: physical chemical hazard: explosive, oxidising, extremely flammable, highly flammable, or flammable; health hazard: irritant, harmful, corrosive, toxic, very toxic, or as a carcinogen, mutagen, or reprotoxin; or environment: very toxic, toxic, or harmful to the environment.
If a preparation does not meet the CLP criteria for classification, a user of the preparation may still request an SDS. The supplier will have to honor this request if individual substances, within the preparation, are greater than or equal to 1% weight for weight (w/w) for non-gaseous preparations and greater than or equal to 0.2% by volume for gaseous preparations and are:
- Hazardous to human health or the environment; or
- Have been assigned a permissible workplace exposure limit.
The SDS must be supplied in Turkish, including the chemical names that appear anywhere in the document. The Turkish SDS must be compiled by a certified person within Turkey. The SDS will follow the standard format that is set out in the regulation. Sixteen headings are identified for inclusion in the SDS. No sections of the SDS are to remain blank. In the event that no data are available, a statement must be inserted that will indicate the reason that no specific data are provided. A statement such as "not applicable" or "data lacking" is sufficient and required.
Once completed, a hard copy version of the SDS must be sent to users. In addition, the SDS must be submitted in electronic form to MOEF.
Given that Turkey currently applies chemical regulation that is consistent with DSD and DPD, it is no surprise to see similarities to that which is required under the European SDS Directive (Directive 91/155/EEC). This directive has now been replaced by the requirements of Annex II of the REACH Regulation. We anticipate that GHS implementation in Turkey will resemble the current CLP Regulation (1272/2008) implemented within the EU.
The United Nations' Strategic Approach to International Chemicals Management (SAICM) from 2006 urges each nation to make efforts to reduce hazards associated with the use of chemicals. In response to this request, South Korea has taken steps to implement a process for the management of chemicals with the objective of minimizing the harmful effects that substances have on human health and the environment. The process will be ongoing until 2020.
The South Korean management program for chemicals, prepared by the Ministry of the Environment (MOE), is intended to ensure that by 2020 more than 80% of information relating to the harmful effects of a substance is available as well as targeting a 32% reduction in use, by volume, of substances classified as a carcinogen. MOE states that any substance subject to current or future international control should be managed in "a more enhanced way." Specifically, MOE identifies persistent organic pollutants, mercury, and nanomaterials as substances of interest needing enhanced controls.
Seven Ministries have been consulted and each is committed to making detailed plans and developing the process throughout 2011. Consultation of the draft regulation is underway and is extended to other government agencies with a view to complete the legislative process by the end of this year. The regulation must come into force two years from its date of acceptance, with a current target date of January 2013. Ministers are currently debating the regulation that will shortly be published and followed by a public consultation period. Historically, the Korean government publishes a translation of its regulations in English on its website with a disclaimer that the Korean language version takes preference should any conflict arise. We anticipate, as with other regulations, that an English translation will be made available for public consultation. More information is available online.