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The additions include three substances that are toxic to reproduction and one endocrine disruptor. The Candidate List of substances of very high concern (SVHCs) now contains 209 substances that may have serious effects on people or the environment.
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In Australia, new scheme the Australian Industrial Chemicals Introduction Scheme (AICIS) replaced 30 year old National Industrial Chemicals Notification and Assessment Scheme (NICNAS) on 1st July 2020. This new scheme regulates the introduction
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The Thailand Cosmetic Regulation or Cosmetic Act B.E. was officially finalized in the year 1992. Thailand’s Ministry of Public Health has updated its lists of prohibited and restricted substances for use in cosmetic products.
Many of the chan
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The Ministry of Health and Welfare in Taiwan circulated a list of Prohibited ingredients in Cosmetic Products on 3 December 2020. After 60 days of publication consultation, the list is now expected to come into force on 1 July 2021. Cosmetic prod
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On November 19th, 2020, the Standardization Administration of China (SAC) published the Guidelines for the Use and Control of Key Chemical Substances in Consumer Products (GB/T 39498-2020), with its effective date on June 1st, 2021.
The
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On 23rd March 2021, Chinese National Medical Products Administration (NMPA) launched a new platform for the registration and filing of cosmetics to support the implementation of ‘Cosmetic Supervision and Administration Regulation (CSAR)’ and
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The Government of Canada evaluated the risks of PFOS, PFOA, and LC-PFCAs, and published the findings in screening assessment reports in 2006 and 2012. The PFOS, PFOA, and LC-PFCAs (and their salts and precursors) are prohibited through regulations
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On July 9th, ECAH added eight chemicals to the Candidate List of SVHC, expanding the list from 211 to 219 entries. These newly added substances are used in consumer products such as cosmetics, scented articles, rubber, textiles, or as solvents an
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The Gulf Standardization Organization (GSO), on the 7th of July 2021 issued an update to the draft Gulf Technical Regulation No. GSO 2528/2021 "Cosmetic products – Technical Regulation of cosmetic and personal care products claims". This was done t
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Canada’s environment and health ministries have suggested including solvent violet 13 to the Cosmetic Ingredient Hotlist, a move that would restrict the dye’s use in cosmetics placed in the country.
The two government agencies nomin
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Canada’s health and environment ministries have urged the conditions on the use of phosphonic acid, P,P′-(1-hydroxydodecylidene)bis-, allowing the limited amounts of the anti-adhesive to be used in certain cosmetic products. Since the
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China implemented CSAR in January 2021, and this was after 30 years of waiting. China recently took another massive step by approving its first cosmetics ingredients under CSAR. As recently published in the International Nomenclature Cosmetic Ing
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The National Medical Products Administration of China (NMPA) announced their working plan for the second half of 2021 on 5th July 2021. This working plan is based on the haircare products and children’s cosmetics work done in the first half of
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On the 6th of August, the National Medical Products Administration (NMPA) enacted “Measures for Cosmetics Supervision and Administration” which will come into force from the first day of 2022. This is the first regulation that focuses on cosmetic
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On the 30th of September, the National Medical Products Administration of China (NMPA) published the final Regulations on the Supervision and Administration of Children’s Cosmetics which is expected to take effect on the 1st of January 20
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On the 1st of December 2021, China’sNational Medical Products Administration (NMPA) published a special label for cosmetics that are intended for use by children under 12 years old.
From 1 May 2022, newly registered children’s cosmetics must
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The European Commission published a Regulation amending several annexes of the cosmetics regulation, prohibiting certain substances from use in cosmetics. This regulation was published on the 3rd of November and came into effect on November 23, 20 da
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European Union (EU)
A new Chemicals Strategy for Sustainability was presented by the EU in 2020 as part of the EU Green Deal. This year, there are major implementations that will be made to achieve this strategy as Europe transitions to a toxi
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The Candidate List of Substances of Very High Concern (SVHC) now contains 223 entries. On 17th January 2022, ECHA added four hazardous chemicals that are commonly used in cosmetics to the candidate list.
Under the REACH regulation, companies have
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Based on the China cosmetic regulation (Cosmetics Supervision and Administration Regulation, CSAR), the National Medical and Pharmaceutical Agency (NMPA) published the good manufacturing practice ‘specifications’ for cosmetics. This notification
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Under EU Cosmetics Regulation, the commission banned
some uses of methyl-n-methylanthranilate as a fragrance ingredient. This is an ingredient usually
used in the production of shampoos, soaps, and other beauty products. In alignment with the initi
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On the 13th of February,
Switzerland had a vote to decide if full animal testing should be banned or
not. This includes animal testing for both scientific and medical research.If voted for, the ban would include:·
a ban on the importa
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On the 2nd of September
2021, the Chamber of Senators in Mexico passed the bill to prohibit the use of
animals for cosmetics testing. The bill stipulates that cosmetic product cannot
be manufactured, imported, or marketed when their final producti
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In January 2022, Cosmetic Alliance (CA) and
a representative from their allied stakeholder coalition met with Health Canada
(HC) officials to discuss the ban of cosmetics testing on animals in Canada. HC
is currently working on publishing a policy
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On February 9,
2022, the National Health Surveillance Agency (ANVISA) published a resolution
addressing ultraviolet (UV) filters allowed to be present in cosmetics. In
addition, Resolution 600 formally
adopts MERCOSUR's resolution 44/2015 amended
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On 7 March 2022, Australia notified the changes to its laws regarding Mercury, in a
bid to comply with the Minamata Convention obligations. Due
to the amendment, Australia now prohibits the import and export of elemental
mercury, also known as m
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On February 15, 2022, the National Medical
Products Administration of China (NMPA) published final measures for cosmetic
companies to establish systems for monitoring adverse reactions of cosmetics. It
is expected to come into force on October 1
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In February
2022, the Ministry of Food and Drug Safety (MFDS) in South Korea proposed
amendments to the ‘Regulation on Safety Standards, etc. of Cosmetics’. This is
the cosmetics policy enacted in 2015 to guide the manufacture and import of co
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The Health Canada’s revised in-commerce list (R-ICL) of
chemicals used in food, drugs, and cosmetics no longer includes 602 substances
that are not commercially active. These substances are therefore not subject to
notification under the Food an
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The National Institution for Food and Drug Control of China (NIFDC) published the draft revision of “Safety and Technical Standards for Cosmetic” (Safety Standards) on March 31, 2022. This is the first-time revision of the Safety Standards since
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On the 29th of March 2022, the European Commission opened a public consultation for the Cosmetic Products Regulation (Regulation (EC) No 1223/2009).
The objective of this revision is to ensure human health and improve the functioning of the inter
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The Brazilian Health Regulatory Agency notifies World Trade Organization (WTO) of several resolutions for cosmetics and personal hygiene products which are proposed to enter into force with the earliest start being on May 2, 2022. Earlier in March 20
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The Ministry of Food and Drug Safety (MFDS) in South Korea updated the regulation on precautions when using cosmetics and labeling of allergens under Cosmetic Act on April 27th, 2022. This is due to the update of the enforcement rule of the Cosmetic
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The Ministry of Food and Drug Safety (MFDS) in South Korea updated the regulation on cosmetic safety standards on April 1st, 2022. This is to strengthen the safety management of cosmetics and protect public health, as well as strengthening the compet
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The European Commission updates the glossary of ingredient names commonly used in cosmetics production. This was done to correct the names of ingredients that were written incorrectly while some were updated to comply with the recent changes made in
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On April 27, 2022, the General Department of the National Medical Products Administration (NMPA) extends the deadline for submitting certain data under the cosmetic regulation from May 1 until December 31. This decision was made due to the rising ca
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The Brazilian Health Regulatory Agency (ANVISA) is responsible for regulating and approving guidelines and use of pharmaceutical drugs, sanitary standards, and regulation of the food industry. In the last month, ANVISA has proposed modifications to a
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The amendments to the “List of Ingredients Prohibited from Using in the Cosmetic Products” were made on April 27, 2022, by the Ministry of Health and Welfare of Taiwan. The statement stipulates that cosmetics should not contain mercury, lead, or
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Consolidated versions of UK REACH and Classification, Labelling and Packaging (CLP) legislation were published, including the incorporation of amendments made to EU regulations covering post-Brexit national laws. The concern about the effectiveness b
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On June 14, 2022, the United Kingdom’s Secretary of State implemented Statutory Instruments (SIs) which impose the ban on some chemicals in cosmetics and toys. This is in accordance with the EU decision and based on the assessments done by the scie
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An annual declaration must be submitted by the introducers to the authorities for the introductions made during the registration year and the categorization. For chemicals falling with the scope of reported introductions, a one-off pre-introduction
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Exemptions
There are certain chemicals that are exempt from notification, even if they meet the definition of new chemical in China. Any potential notifier should confirm if the substances fall into the range of exemption before starting the registration pr
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EU - COSMETICS
Background
Cosmetics Directive - The Directive 76/768/EC has been governing the composition, labelling and packaging of finished cosmetic products in the European Union since 1976 and is now replaced by the Cosmetics Regulation (EC) 1223/2009.
Cosmetics Regu
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Inventory
CosIng is EU's official database for cosmetic ingredients. It contains the list of ingredients used in cosmetic products, on the basis of information supplied by the
It includes cosmetic ingredients listed in previous inventory of cosmetic ing
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GHS – Classification
Regulation (EC) No 1272/2008 states that it applies to all substances and mixtures supplied in the European Community except where other community legislation “lays down more specific rules on classification and labelling”. The labelling of c
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Regulation (EC) 1223/2009
Scope
Regulation (EC) 1223/2009 on cosmetic products covers cosmetics defined as:
Any substance or mixture,
Intended to be placed in contact with
The external parts of the human body (epidermis, hair system, nails, lips and external genital
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What are the data requirements is it tonnage specific?
There is no tonnage restriction on use of cosmetic product in the EU. Whatever quantity is placed on the market, has to be complied in accordance with the regulation.
The data requirement includes Product information file (PIF) which should be read
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Manufacturer, the Responsible Person and GMP
The term ‘manufacturer’ has a wide definition under the cosmetics legislation and includes the entity which has a product designed or manufactured, and markets the cosmetic product under its name or trademark. Therefore, unless it has explicit
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Animal Testing Prohibited :
The Cosmetics Directive provides the regulatory framework for the phasing out of animal testing for cosmetics purposes. Specifically, it establishes:
Testing ban - prohibition to te
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The Act on the Chemical Substance Control Law came into force in 1973 to prevent environmental pollution by chemical substances that pose a risk to human health or the environment. But it was later updated and amended on May 20th 2009. Full implement
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Substances imported or manufactured in quantities = 1 t/y in Japan, polymers of low concern, intermediates and export only substances are eligible for an exemption from standard notification. Prior confirmation of this exemption status must be obt
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Scope of K-REACH
Within Scope
Substance on its own – New Substances(1) and Existing Substances
Substance in a mixture
Product(2) containing priority control substance
Out of Scope
Naturally occurring substan
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Toxic Substances Control Act (TSCA) Summary
The Toxic Substances Control Act of 1976 provides EPA with authority to require reporting, record-keeping and testing requirements, and restrictions relating to chemical substances and/or mixtures. Certain substances are generally excluded from TSCA,
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Background and Overview
In Brazil, there are specific laws that apply to pharmaceutical products, cosmetics, pesticides, sanitizing products and explosives. However, there is no law applicable to industrial chemicals. In Oct 2018, the National Chemicals Safety Commission (C
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Exemptions
The following products or substances do not apply to these Measures:
(1) medicines, pesticides, veterinary drugs, cosmetics, food, food additives, feed, feed additives, fertilizers and other products, except for new chemical substances that are ch
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Applicant Roles and Responsibilities
Article 11 An applicant for the registration of environmental management of new chemical substances shall, in accordance with the law within the territory of the People's Republic of China, be able to bear legal responsibility independently, and
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Introduction
Australia replced the existing chemical regulation NICNAS to a new scheme Australian Industrial Chemicals Introduction Scheme - AICIS from 1st July 2020.
AICIS regulates chemicals with an industrial use and requires introducers of industrial che
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Scope of K-BPR
Within scope
Consumer chemical product (1)
Biocidal substance (2)
Biocidal product (3)
Biocidal treated product (4)
Out of scope
Consumer chemical products and biocidal chemicals used for
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The Cosmetic Act
In developing the cosmetics industry and improving public health, the Act regulate matters concerning the manufacture, sale, import, and export, etc of cosmetics. The Cosmetic Act has been enforced since July 1, 2000, and the recent amendment came in
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Scope of the Cosmetic Act
According to the Cosmetic Act, cosmetics include two main categories: functional cosmetics and general cosmetics. Some articles in the Cosmetic Act particularly applies to functional cosmetics. For instance, a person or company who is involved in the
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Main requirement of the Cosmetic Act
1. Main requirement for manufacturers and manufacturer-seller
Manufacturer
Manufacturer-Seller
Definition
Manufacturing all or part of the cosmetics*
(*This excludes manufacturi
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Cosmetic Supervision and Administration Regulations (CSAR)
Chinese cosmetic regulation came into force on January 1, 2021. It regulates all the cosmetics and cosmetic raw materials in China. All the manufacturers, importers and exporters must ensure that their cosmetic products and raw ingredients meet the c
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Overview
China's State Council published the final version of the COsmetic Supervision and Administration Regulation (CSAR) and this came into force on 1 January 2021 and replaced the Cosmetic Hygiene Supervision REgulations. CSAR regulates all cosmeti
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Cosmetic Existing Raw Materials
Cosmetic raw material is defined as natural or synthesis ingredients which are used in making cosmetic products. According to the requirements, existing ingredients need to do record filing submission, while new ingredients must do a formal registra
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Label Requirements
For imported cosmetics, they must be labeled in Chinese and contain the following information:
Product name, special cosmetics registration certificate number
The name and address of the registrant, recorder, and entrusted production enterprise
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Annual Reporting
CSAR also introduces the annual reporting requirements. Applicants should submit the annual report of cosmetics from January 1 to March 31 each year.
Basic information and production of new cosmetic ingredients.
Information on cosmetic registran
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Information or submission
Basic information and manufacturing process
Trade name
Composition
Basic properties
Purpose of use
Suggested percentage in cosmetics
Restrictions on the use of raw materials
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UK - COSMETICS
Annual Declaration
Anyone who is registered under AICIS to introduce industrial chemicals or products containing industrial chemicals (for example, cosmetics, paints and plastics) must submit an annual declaration. This applies to all of your chemical introductions, r
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The Cosmetics Rules, 2020
In the Cosmetics Rules, 2020, the cosmetics' definition remains the same.However, the concept of "New cosmetic" is introduced for the first time. It is defined as ‘a cosmetic that contains a novel ingredient that has not been used anywhere
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List of forms
Form
Purpose
Cos-5
Application to obtain cosmetics manufacturing license
Cos-7
Self- certificate compliance for GMP
Cos-8
Cosmetics Manufacturing license
Cos-10
Form for sampling
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Objectives of FDA
The FDA regulates food, drugs, medical devices, biologics, cosmetics and radiation emitting products in the USA.
FDA’s Centre for Devices and Radiological Health (CDRH) is responsible for regulating manufacturers of medical devices. Medi
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The Cosmetic Act
The Cosmetic Act is issued by the Pharmaceutical and Medical Devices Agency (PMDA) of Japan, and it is supported by a series of subsidiary rules, standards and guidance documents issued by the competent authority, Ministry of Health, Labour and Welfa
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Thailand Cosmetics Regulation
Cosmetic product refers to any substance or preparation intended to be placed in contact (by applying to, massaging or rubbing into, sprinkling or spraying on, dropping onto, introducing into, perfuming, or by any other means.
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The main requirements of the Cosmetic Act
The ingredients
"The ingredients of cosmetic products, including the impurities they contain, must not contain anything that could cause infection or make the use of cosmetic products hazardous to health” --Standard for Cosmetics
To help the manu
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Import & Manufacture of Cosmetic Product
Any company or a single individual who wants to import or manufacture cosmetics product for sale in the kingdom, must inform about the complete details of cosmetic product to be imported or manufactured to the authority of concern.
The s
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Registration of Specially controlled cosmetics
Permission for manufacturing or importing samples of products for registration is required before the registration process begins. The manufacturer or importer shall submit an application with attachments to FDA for review. The Requirements for Regi
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Products- Inclusions & exclusions
Any products having pharmaceutical characteristics such as those affecting or altering the functions or structure of human body or presenting as pharmaceutical products are outside the scope of cosmetic regulation. List of names of cosmetic product
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EPA and Nanomaterials
More than 1,300 commercial goods contain manufactured nanoparticles, including medical equipment, textiles, fuel additives, cosmetics, polymers, and more. The most common nanomaterials that may have human and environmental health concerns are studied
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EPA & Nanomaterials
More than 1,300 commercial goods contain manufactured nanoparticles, including medical equipment, textiles, fuel additives, cosmetics, polymers, and more. The most common nanomaterials that may have human and environmental health concerns are studied
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Cosmetic Packaging Waste- Circular Economy in India
Circular Economic aims to Reduce Waste by keeping the products in use, which signifies each product's importance. The circular economy seeks to make the most of the material resources available by applying three basic principles: reuse, reduce, a
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Cosmetics Packaging waste- Circular Economy in Europe
Circular Economic aims to Reduce Waste by keeping the products in use, which signifies each product's importance. The circular economy seeks to make the most of the material resources available by applying three basic principles: reuse, reduce, a
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Nanomaterial in Cosmetics
The main regulatory framework for cosmetics in the EU is EU Regulation 1223/2009. Based on this structure, a list of all NMs used in cosmetics should be available to all consumers. Most recently (i.e., October 2019), the EU updated the existing guida
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Regulation
Nanomaterials and nanotechnology products are also subject to five general environmental standards in the United States. Table 2 illustrates where any nanomaterials-containing items fall under the purview of these five Acts. From 2009 to 2014, the EP
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Toxic Substance Control Act
Any chemical that is imported or made in the United States but is not listed by the Environmental Protection Agency (EPA) is a novel chemical that should be added to the list before being sold in the United States. The Toxic Substances Control Act (T
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Nanomaterial regulation in Cosmetics
The FDA's existing regulatory framework for nanotechnology-enabled cosmetics is in flux. In 2007, the FDA established a task force to explore the future of nanotechnology goods. The FDA has now issued advice on nano-enabled cosmetics safety (FDA,
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Regulatory Framework of Nano-Pharmaceutical
A nano pharmaceutical is a pharmaceutical preparation that contains nanomaterials for internal or external use on the body for treatments, diagnostics, or any other health benefit, and that contains materials with a size scale of 1 to 100nm in at lea
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Nanomaterial Regulation- Various Sectors
Nanomaterials have been used in Japan for some time in products such as home appliances, food, food containers, cosmetics, automobile parts, pharmaceuticals, paints and inks, and textiles.
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