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CTPA Annual Report 2019
Israel
During 2018, Israel initiated an effort to further align the local regulatory framework with the EU Cosmetics legislation by introducing an amendment to the Pharmacist Regulations, which include cosmetic products within the legal scope. Further developments to the legislation
were stayed and no progress was pursued during 2019. However, the Israeli Ministry of Health published a guideline to be used in the development of new legislation in the future by establishing a set of principles to be followed.
Morocco
New Registration Process: as of 1 April 2019,
the ‘Direction des Medicaments et de la Pharmacie’ (DMP) requires companies placing their products on the Moroccan market to register via a new importation process for cosmetic and personal care products.
Saudi Arabia
SASO Technical Regulation on Disposable Plastics: the Saudi Standards, Metrology and Quality Organisation (SASO) has published the Technical Regulation for Degradable Plastic, requiring disposable plastic products made from polypropylene and polyethylene with a film thickness of less than or equal to 250 microns to be oxo-biodegradable. Initially planned for implementation
in 2019, SASO has announced an implementation postponement until 1 April 2020.
Arabic Labelling: the Ministry of Commerce (MoC) in Saudi Arabia has issued a law which requires that all on-pack labelling requirements should be in Arabic, including ingredient listings.
Russia
Unique Product Identifier Marking: the Russian Authorities introduced a law establishing the requirement
for the introduction of a Unique Product Identifier (UPI) on consumer products’ packaging. Perfumes and eau de toilette are currently the only cosmetic items falling under the scope as authorities believe such items to be at greater risk of counterfeiting. Companies selling products in Russia will have to introduce all the information on products currently on the market by 1 October 2020.
South Korea
The Korean Ministry of Food and Drug Safety (MFDS) released an announcement amending ‘Standards
for Marking Cosmetics Usage Precautions and Fragrance Allergens Labelling’. The amended standard is effective from 1 January 2020.
Taiwan
Good Manufacturing Practice (GMP) – Draft Notification to the World Trade Organisation (WTO):
on 1 March 2019, Taiwan Food and Drug Administration (FDA) notified to WTO proposed enforcement dates for cosmetic product categories for which the manufacturing plant will be required to comply with GMP Regulations, as published by the FDA.
Turkey
Cosmetic Product Notification and Regulatory Amendments: the Turkish authorities published proposed regulatory amendments for cosmetics in the Official Gazette No. 25823 of 2005. These were expected to take effect in June 2019. Continued engagement with the relevant stakeholders and the Turkish authorities is maintained,
but no significant progress has been achieved.
USA
Proposed Sunscreen Monograph: the Food and Drug Administration (FDA) is reviewing the ‘Sunscreen Drug Products for Over-the-Counter Human Use’ Monograph,
to implement a final monograph for non-prescription, Over-The-Counter (OTC) sunscreen drug products.
Hawaii: from 1 January 2021, Hawaii will ban sunscreens containing the UV filters oxybenzone and octinoxate.
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