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Monthly review of international cosmetics news February -2017
News summary




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News events

Risk level

Reason

EU 2017/237 revised appendix III to cosmetics regulations

high

Regulatory changes

EU 2017/238 revised the maximum allowable use concentration of two benzophenone -3 in cosmetics regulations UV from 10% to 6%

high

Regulatory changes

French authorities found cosmetics claims and labels did not meet the requirements.

in

Enterprises should pay attention to irregularities.

Irish officials solicited public opinion on the ban on plastic beads.

low

No legislation has yet been formed.

Us NGOs have petitioned the food and Drug Administration (FDA) to ban lead acetate for hair dyes.

low

Petition, but enterprises should pay close attention to the trend.

Australian official recall of nail polish and tattoo stickers

high

Attention should be paid to recall reasons.

Australia's reform of cosmetics regulations

low

Not yet effective

Shandong food and Drug Administration 2016 announcement of cosmetics inspection sampling information (2016 third, total fourth issues)

in

The impact is great. Enterprises should check their own reasons for the announcement.

Gansu food and Drug Administration cosmetics quality bulletin

in

The impact is great. Enterprises should check their own reasons for the announcement.

Circular of Sichuan food and Drug Administration on 2 batches of substandard cosmetics

in

The impact is great. Enterprises should check their own reasons for the announcement.

Guangdong provincial food and Drug Administration issued the first issue of 2017

in

The impact is great. Enterprises should check their own reasons for the announcement.

Hongkong Consumer Council exposure: 9 into moisturizing milk contains allergenic ingredients

in

Great influence

The State Food and Drug Administration's pilot work on the import and export management of cosmetics for non special purposes was officially launched in Pudong New Area, Shanghai.

in

Great influence





Regulatory developments








Europe


1. EU 2017/237 revised appendix III (2017-02-10) in cosmetics regulations

In February 10, 2017, the EU issued (EU) 2017/237 to amend the appendix III of cosmetic law (EU) No 1223/2009. The revised content came into effect 20 days after the official communiqu of the EU was released. The amendment added 8 restricted substances, and the main content of the amendment is hair dye. Take one of the substances as an example.


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Chemical name

CAS number

EC number

Using product type

Restrictive conditions

Ethanol, 2,2 '- [(2- nitro-1,4-phenylene) diimino]bis- (9CI)
Ethanol, 2,2 '- [(2- nitro -1,4- phenyl) two imine] double - (9CI)

84041-77-0

281-856-4

Oxidizing hair dyes

The maximum concentration of mixed use should not exceed 10% under the oxidation conditions (September 3, 2017) - prohibit the simultaneous use of nitroso preparations; the highest content of nitrosamine components: 50 g/kg; - preservation in containers without nitrite.

Non oxidized hair dyes

1.5% (September 3, 2017)


2. EU 2017/238 revised the maximum allowable use concentration of UV sunscreen, two benzophenone -3, from 10% to 6% (2017-02-10).

Before the amendment, the maximum allowable use concentration of two benzophenone -3 was 10%. In December 16, 2008, the European Commission on Consumer Safety (SCCS) issued a comment on the two benzophenone -3 (SCCP 1201/08) and concluded that two benzene ketone -3 as a sunscreen agent does not pose a risk to human health in sunscreen products and all types of cosmetics, no more than 6% and 0.5%, respectively, but does not include contact allergy and potential photosensitivity.


Therefore, according to SCCS's opinion, the European Commission revised the maximum permitted concentration of the substance.At the same time, its use in protective products has been limited, that is, in order to protect the product formula as sunscreen, the use should not exceed 0.5%. The corresponding warnings should be marked on the label: Contains Benzophenone-3. However, when the concentration is less than or equal to 0.5% and is only used for protective products, it is not required to mark the warning.


3. French authorities found cosmetics claims and labels did not meet the requirements (2017-02-17).

The French competition, consumer affairs and anti fraud Bureau issued a report saying the country did not play a good regulatory role in cosmetic labels. The Agency conducted a survey on infant and child products to verify cosmetic claims that information on cosmetic labels, claims, recipes and other information was not adequately controlled.


In order to meet the cosmetics claim report issued by the European Commission, the agency sampled 1030 samples. 46% of them were considered unqualified and 91 were considered to be negatively related to consumers' health because of non compliance.The report points out that the three main problems are:


1) lack or insufficiency of evidence.


2) claims (such as high regeneration capacity) that are suspected of drugs or can not determine the nature of their components, such as "Calendula relieving";


3) claims to contain a component, but the product does not contain it.


The agency also pointed out that there are also some products claiming such as origin, manufacturing methods (such as manual), natural or hypoallergenic properties.


4. Irish officials solicit public opinion on the ban on plastic beads (2017-02-16)

Ireland has begun soliciting public opinions on the prohibition of the sale, manufacture and import of cosmetics, personal care products and detergents containing plastic beads. The deadline is March 24th.


Products usually containing plastic beads include bath milk, body scrub, facial cleansing products.


Meanwhile, the UK's comments on the ban on plastic beads were closed on February 28th.



America


U.S.A


5. the US NGOs petitioned the food and Drug Administration (FDA) to prohibit lead acetate from being used in hair dyes (2017-02-28).

The use of ingredient lead acetate will cause serious lead exposure. Therefore, the US non governmental organizations, including the Environmental Defense Fund (EDF), earth Justice (Earthjustice), the natural resources protection association (Natural Resources Defense Council), and the environmental health center (acetate), have applied for approval in the pigment additive application to prohibit the approval issued in 1980 and prohibit it from being used in hair dyes. FDA was asked to respond to the petition within 180 days.


In 1980, FDA issued a rule limiting the use of this substance in hair (excluding facial hair) products. The maximum concentration used in the final product was 0.6% (6000 ppm). But it does not limit the frequency of usage, the amount of usage and who can use it. It is currently banned in cosmetics in the European Union and Canada.


Australia


Australia


6. Australian official recall of nail polish and tattoo stickers (2017-02-09)

On 02 2017, 09, the tattooing paste and nail polish from a company were recalled by the Australian authorities. The reason for the recall was that the labels of the two products were not fully labeled, violating the provisions of the 1991 Australian trade practices (consumer product information standards) Regulations on the whole components.


Risk of incomplete component marking


Users may be allergic to certain components. Products that are not fully labeled can not be identified by consumers.


What should consumers do?


Consumers should immediately stop using related products and exchange them with relevant companies or make full price compensation.


On 2017 02, 21, a company's tattoo sticker was recalled by the Australian authorities. The reason for the recall was that the label of the product was not marked full components, which violated the provisions of the 1991 Australian trade practices (consumer product information standards) Regulations on the whole components.


7. Australia's reform of cosmetic regulations (2017-02-14)

In December 23, 2016, the Australian National Industrial Chemicals Notification authority (NICNAS) announced that it would continue to solicit public opinion on reform and is currently gathering information on the timing of its activities. NICNAS has issued fourth public consultation papers, and called for feedback from the public. Australia announces NICNAS surveillance chemicals, including cosmetics, to simplify procedures, benefit producers and importers and reduce regulatory burden. Risk, chemicals, because of different risks, the implementation of regulatory measures can be divided into three categories: exemption, reporting (low risk) and assessment (medium to high risk).


Exemption chemicals can be directly imported without any entry assessment or compliance statement, requiring only the corresponding chemical companies to keep records and conduct audits to ensure safety and compliance.


Reporting chemicals need self-assessment and pre market announcements. Chemical companies should submit annual compliance statements to NICNAS and obtain annual audit from the registration organization.


The assessment of chemicals is the most comprehensive. Assessment certificates must be carried out before proceeding, and risk assessment is carried out. Certificates may contain details. If risks can not be controlled, they are likely to be rejected. If there are new risks, NICNAS will conduct post marketing audits and assessments.



Asia


China


8. Shandong food and Drug Administration 2016 announcement of cosmetics inspection sampling information (2016 third phase fourth) (2016-12-30)


The food and Drug Administration of Shandong organized the Gaestgiveriet Hotel to supervise the sampling of bathing and skin care cosmetics. According to the hygienic standard for cosmetics (2007 Edition), 20 batches of substandard products were detected. The unqualified items were methyl chloroisothiazolinone and methyl isothiazolinone mixed with magnesium chloride and magnesium nitrate.


For the above unqualified products, the Provincial Bureau has asked the relevant municipal council to carry out verification and disposal work according to the regulations, and issue timely verification and disposal information.


9. Gansu food and Drug Administration announcement on cosmetic quality (2017-02-14)


In order to further strengthen the quality supervision of cosmetics and protect the legitimate rights and interests of the people, in 2016, the Gansu food and drug administration carried out supervision and inspection on four major categories of cosmetics, including toothpaste, hair care, skin care and aromatics. In the whole province, the results of the three batches of 324 batches of hair products, skin care and aromatic products were announced.


The above 324 batches of cosmetics were tested by the Gansu Provincial Institute of pharmaceutical inspection, and the results were in compliance with the 323 batches. The results were not in conformity with the 1 batches. They were labeled "39 Tong Tai Shu Mian shampoo and shower gel" produced by Guangdong Longhu daily chemical factory in Zhaoqing province (specifications: net content 200ml, production batch number: ED20A01C, valid to 20180419).


For the cosmetics that are not up to the standards listed in the annex to the present Notice, the food and drug administration departments of the prefectures and prefectures shall thoroughly check the quantity, source and direction of the unqualified products, and notify the food and drug regulatory departments concerned where the relevant information is distributed to the source or the place of origin. On the basis of finding out the facts, the relevant enterprises shall be investigated and dealt with according to law and regulations, and the public security departments concerned shall be investigated for criminal responsibility for the alleged crimes.


10. Sichuan food and Drug Administration announcement on 2 batches of substandard cosmetics (first 2017) (2017-02-16)


The Sichuan food and Drug Administration (FDA) conducted the inspection of cosmetics supervision in 2016. After inspection by the Sichuan food and drug inspection and testing institute, it was found that the nominal product name was "jade cherry plant herb series whitening beauty cream (No. 2)", "Yu Qi Hua Hua Dian Mai Bai Bai classic (herbal extract, freckle No. 1 + herbal extract two"). 2 batches of substandard products exist illegally added prohibited substances, illegal use of restricted substances and other issues (see Annex), which belong to illegal products. The following information is hereby circulate as follows:


1. The Sichuan food and drug administration has requested the food and Drug Administration of Ganzi Tibetan Autonomous Prefecture and Mianyang to file an investigation on the enterprises operating the above products, thoroughly investigate the batch, quantity and source of the unqualified products, and inform the food and drug administration departments of the relevant information notified products, such as suppliers within the scope of this Municipality, the food and Drug Administration sub bureaus of the suppliers should be notified at the same time. On the basis of finding out the facts, the relevant enterprises shall be investigated and dealt with according to law and regulations, and the public security departments concerned shall be prosecuted for criminal responsibility for the alleged crimes. The results of the investigation were reported to Sichuan food and drug administration before March 25, 2017.


Two, all commercial enterprises operating illegal products above should immediately stop selling, seal up the underground shelves, and report the situation to the local food and drug administration departments at or above the county level. The storage and quarantine departments of all regions were reported to the food and Drug Administration of Sichuan by the Municipal Food and drug administration before March 25, 2017.


Three, Sichuan food and Drug Administration reminds consumers that they should buy cosmetics through regular channels, obtain and retain relevant documents. If the illegal products reported are still being sold, please timely report complaints. Telephone number: 12331.


11. Guangdong food and Drug Administration's unqualified cosmetics notice 2017 phase first (2017 nineteenth) (2017-02-28)

Guangdong food and Drug Administration in the cosmetics safety special rectification action, through the supervision and sampling inspection found that marked "beauty Yan Bao super beauty cosmetology cream" and other 67 batches of products exist illegally added prohibited substances and heavy metal exceeded the problem, is an illegal product.


The Guangdong food and drug administration has requested that the relevant food and drug regulatory authorities of the relevant cities should investigate the above-mentioned enterprises in accordance with the law, immediately order the enterprises to recall the unqualified products, thoroughly check the batches, quantity and direction of the disqualified products, and notify the relevant food and drug regulatory departments of the products that are distributed to the relevant places. For the products suspected of counterfeiting, we must go deep into the channels of the relevant business enterprises, and crack down on the behavior of making fake and selling fake cosmetics. On the basis of finding out the facts, we shall investigate and prosecute the illegal enterprises in accordance with the law, and transfer the suspected crimes to the public security departments for criminal responsibility; and investigate and report the results to the food and Drug Administration and make them known to the public.


The users of cosmetics should immediately stop selling the products and seal the above substandard products on the underground shelves, and report the situation to the local food and drug administration departments of the local people's governments at or above the county level. The local food and Drug Administration will report to the food and drug administration before March 31, 2017.


Guangdong food and Drug Administration reminds consumers that they should buy cosmetics through regular channels, obtain and retain relevant documents. If the illegal products reported are still being sold, please timely report complaints. Telephone number: 12331.


12. Hongkong Consumer Council exposure: 9 into moisturizing milk containing allergenic ingredients (2017-02-15)

Recently, the Hongkong Consumer Council has conducted an in-depth investigation of 61 lotion on the market, including 15 claims for any skin, 7 dry and dry, 19 sensitive skin or eczema, 6 infants and adults to apply products, and 8 did not indicate suitable skin. The price of each bottle is between 18 and 675 Hong Kong dollars. The study found that only 4 samples of the product did not contain the following sensitized ingredients: lanolin, spices and sensitizing spices, releasing formaldehyde preservatives, methyl isothiazolinone and suspected endocrine disruptors.


There were 6 samples indicating the sensitized spices referred to as HICC; 3 samples were labeled with methyl isothiazolone. There are 4 sunscreens containing two phenyl ketones -3, methoxy cinnamic acid ethyl hexyl ester, and 2 samples containing lanolin.


In addition, the Consumer Council reminds that many moisturisers will add propylene glycol and urea, but not all moisturisers are suitable for infants and young children. Overseas studies indicate that propylene glycol is not recommended for infants under the age of 2 because of the possibility of producing non immune contact urticaria and irritant or sensitive contact dermatitis in infants.And urea has the chance to stare or burn infants' skin.


The Consumer Council also found that most of the samples clearly indicate the usage dates, but they are different in form, including the use period, expiration date, production date and shelf life of Kaifeng. The 3 section also indicates the date of production, the period of validity and the period of use after opening. The data are comprehensive.


Consumer body skin care milk can be used to note the following suggestions:


Pay close attention to the list of ingredients and avoid products containing sensitive reactions to the skin.


Avoid skin care products containing high concentrations of propylene glycol or urea for infants and young children to reduce sensitization or irritation to skin.


Choose suitable body moisturizing products according to season, personal skin and skin condition; after bathing or cleaning the skin, it is a good time to care for the skin.


The period of use of the product after opening is different from 4 to 24 months, and it should be used up as soon as possible after opening.


13. the trial of the import and export of non special purpose cosmetics by the State Food and drug administration was officially launched in Pudong New Area, Shanghai (2017-03-01).


In March 1st, the import and export management system of imported non special purpose cosmetics was formally launched.


According to the new record management regulations, from March 1, 2017 to December 21, 2018, the first imported non special purpose cosmetics imported from Pudong New Area port of Shanghai and registered by the territory responsible persons in Shanghai Pudong New Area shall be adjusted by the current examination and approval management to record management. The domestic responsible person can carry out relevant business activities after filing the relevant materials with the archival management requirements. After the product is put on record, the regulatory authorities find that illegal activities are corrected or punished according to law. The pilot scheme is to innovate the product management mode on the basis of not reducing product safety supervision requirements. The focus of supervision should be adjusted from the approval of admittance to strengthening supervision afterwards.



Product recall case


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European Union

Notification state

product

Reason

Measures

Germany

Product category: cosmetics
Product Name: scalp care products
Product Description: packed in white plastic bottles with a net content of 50ml. Only Batch SH604 batches are contaminated.
Origin: India

Microbiological hazard
The product contains Pseudomonas aeruginosa and over standard thermophilic bacteria (>3000 cfu/g), which is at risk of infection, especially through oral, hand and eye contact.
The product does not comply with the EU cosmetic regulations 1223/2009 requirements.

Operators (importers) take measures:
Withdrawal of relevant products on the market

Serbia

Product category: cosmetics
Product Name: toothpaste
Product Description: plastic hose for packaging.
Origin: India

Microbiological hazard
The product contains thermophilic bacteria (>7100 cfu/g), which is at risk of infection, especially through oral, hand and eye contact. In addition, the product contains allergen substance Eugenol (0.052%) and Limonene (0.021%), but it is not indicated on the label.
The product does not comply with the EU cosmetic regulations 1223/2009 requirements.

Operators (dealers) take measures:
Withdrawal of related products from end-users
Coercive measures:
Prohibition of listing and other supplementary measures

Estonia

Product category: cosmetics
Product Name: skin care products
Product Description: white plastic hose with green lid and net content 50m.
Origin: Russia

Chemical hazards
The product contains methyl isothiazolone (MI) and methyl chloroisothiazolone (MCI), and two substances are forbidden to be used for stay cosmetics. Allergic people exposed to products containing such substances are likely to have allergic contact dermatitis.
The product does not comply with the EU cosmetic regulations 1223/2009 requirements.

Operators (importers and retailers) take measures:
Withdrawal of relevant products on the market

China

Food and cosmetic information not approved in December 2016 -
The 64 cosmetics are not allowed, involving emulsion, cream, lip balm, etc.

The main reason is that the label is unqualified and fails to provide certificates or qualified certification materials as required.

Coercive measures:
Refuse entry




(source: Tianxiang Intertek)


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