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January 2017 Global Cosmetics Recall Case Summary
Industry News 2017-02-14

 Europe

1. The European Commission informs the WTO of CMR material limits (2017-01-04)

The European Commission informs the WTO of the CMR substances listed in REACH Appendix XVII. Substances classified as CMR substances include:

1) bisphenol A-bisphenol A;

2) phenol, dodecyl-, branched;

3) phenol, 2-dodecyl-, branched;

4) phenol, 3-dodecyl-, branched;

5) phenol, 4-dodecyl-, branched;

6) phenol, (tetrapropenyl) derivatives.

2. The European Commission informs WTO of proposals for changes in cosmetics regulations (2017-01-17)

The European Commission informs the WTO of the draft amendments to the three flavors and allergens in Appendix II of the Cosmetic Code (EU1223 / 2009).

The Consumer Safety Science Council (SCCS) found the following flavors of allergens for cosmetic insecurity:

1) Atranol (moss black aldehyde);

2) Chloroatranol (chlorinated moss black aldehyde);

3) 3 and 4- (4-hydroxy-4-methylpentyl) cyclohex-3-ene-1-carbaldehyde (HICC).

Two years after the entry into force of the draft, cosmetics containing one or more of these substances will be banned from selling in the EU market. By then, these products must be fully withdrawn.

A formal vote on the draft regulations is expected in mid-March in the Cosmetics Committee. It is expected that the European Parliament and the Council will be able to adopt the draft shortly.

As the internal cosmetics policy changes, the progress of the proposal has been postponed from 2014.

The agreement to expand 56 other substance labeling requirements ended in early 2014. Cosmetics and Personal Care Industry The European Trade Association informs the Chemical Observation Society that the committee is still discussing public consultation responses.

3. The European Commission for the Safety of Consumer Safety (SCCS) said that the use of preservative polyaminopropyl biguanide (PHMB) at a concentration of 0.1% was safe (2017-01-18)

The European Commission has made it clear that EU regulations are not automatically prohibited for CMR substances and that SCCS produces 0.1% polyaminopropyl biguanide (PHMB) at the first assessment of carcinogenic, mutagenic and reproductive toxicity (CMR) ) Can be used safely.

The European Commission in September last year that the ban on CMR substances in cosmetics must be implemented by revising the appendix to the regulations.

The latest draft of SCCS is based on other cosmetic formulations for skin absorption studies, believing that 0.1% of the concentration is safe. On the draft for public comments, to seek time to March 10.

The Danish Environmental Protection Agency (EPA) said that while it supported the comments made by SCCS, it still disagreed with the European Commission's new interpretation of CMR substances in cosmetics. Denmark believes that cosmetic regulations should be interpreted as mandatory under the CLP regulations CMR classification of substances should be automatically prohibited. Danish Minister of Food and Environment said the new policy reduces consumer safety.

A spokesman for the EPD said, "If the views of SCCS on PHMB are maintained after the comment period, we hope that the European Commission will draft a new proposal on PHMB regulation.

SCCS also on the cosmetics preservative hydroxyethoxyphenyl ketone butanone (HEPB) to re-open for comments, to seek time to March 10. The opinion indicates that the use of HEPB in rinsing, oral care and retention products is not safe at concentrations above 2.0%. But also suggested that the preservative HEPB could be considered safe if it was able to provide "more reliable and supported data" on in vitro skin penetration.

4. European Commission's response to CMR carcinogens for use in cosmetics (2017-01-04)

The European Commission last year to clarify how to regulate the carcinogens in cosmetics received questioning and criticism, the European Commission is to give a response.

Traditionally, a substance is classified as CMR (carcinogenicity, teratogenic, reproductive toxicity) according to the EU CLP regulations, and is automatically prohibited for use in cosmetics. However, in September 2016, the European Commission pointed out that the use of CMR substances in cosmetics to meet the EU cosmetics regulations Appendix specific circumstances, it can be understood that, CMR substances are not automatically prohibited for cosmetics. The Danish Ministry of Environment and Food, in an open letter, questioned the European Commission's move and argued that the committee confronted the consumer with potential risks. In response, the European Commission responded. A spokesman for the European Commission claimed that the move was aimed at better protecting the users of cosmetics rather than putting them at risk. The spokesman also pointed out that the European Commission attaches great importance to the health of consumers, and the new health risks continue to improve its protection measures. The European Commission recommends the adoption of specific regulations to determine the regulatory measures for CMR substances in cosmetics.

5. Industry response to the British public request for banned plastic beads public consultation (2017-01-03)

The UK government has launched a public consultation on the public consultation for the manufacture and sale of cosmetics and personal care products containing plastic beads, with a deadline of February 28. The industry has expressed support for this, and pointed out that many companies have voluntarily prohibit the use of plastic beads in the product, but the Government should be clear that the plastic beads in cosmetics is not the main source of pollution.

The Nordic Commission will consider the ban on plastic beads in cosmetics (2017-01-31)

The Nordic Parliamentary Committee supports the proposal to ban plastic beads in imported or domestic cosmetics within the framework of five Nordic countries. The vote for the proposal will be held at the plenary session of the Nordic Council in Stockholm on April 5. But the plastic plastic beads in the plastic pollution of the environment is only a small part of the tires are plastic beads on the largest pollution of marine pollution, so the need for further efforts.

The Norwegian Environment Agency has begun to study if the reduction of the spread of tires and other sources of pollution; Denmark has urged the European Commission in the EU to prohibit the use of plastic beads in cosmetics; Britain, France, Canada and South Korea is currently moving in the direction of the ban on plastic beads Development; the United States in 2016 has been issued plastic ball ban bill.

6. EU ban on three kinds of aromatic substances for cosmetics (2017-01-06)

On January 5, 2017, the European Commission published the G / TBT / N / EU / 436 Bulletin, the Consumer Safety Science Council (SCCS) study found that the new bell aldehyde (HICC), moss black aldehydes (atranol) and chlorinated moss black Aldehyde (chloroatranol) these three kinds of aromatic substances in the use of cosmetics is not safe, so prohibit the use of the above substances for cosmetics.

7. EU cosmetics nano-materials directory has been late for three years (2017-01-11)

The European Commission said three years ago that it will publish a catalog of nanomaterials in cosmetics, but it has not yet been released.

The EU Cosmetics Regulation requires the European Commission to publish a catalog of nanomaterials for cosmetics in the EU market and to provide deadlines for January 11, 2014. But the European Commission has been delayed on the grounds that the quality of information collected from industry is poor. In addition, the European Commission is very much in favor of the industry's attention to human health and the environment, will take a more positive approach.

8. Lithuania, Ukraine informs WTO of changes in cosmetics regulations (2017-01-11)

The Ministry of Health of Lithuania has informed the WTO of the revised amendments to the health regulations, which are subject to microbiological limits for cosmetic and personal care products.

At the same time, the Ukrainian Ministry of Health also informed the WTO to approve the draft cosmetics technical regulations.

The deadline for comments is 60 days after the January 9 notice.

9. Switzerland's cosmetics animal test ban has been formally implemented (2017-01-10)

The Swiss government has officially banned the sale of cosmetics containing animal testing ingredients. The ban was first released in March 2016, consistent with the requirements of the EU cosmetics regulations. Non-governmental organizations said that in addition to EU member states and Switzerland, India, New Zealand, South Korea has been banned animal testing. In early January 2017, the Dutch government announced that it would gradually abolish all chemical safety animal testing institutes by 2025.

10. Draft Swedish Agency for the Open Management of Nano Registration (2017-01-17)

The Swedish Chemicals Agency (Kemi) is currently openly soliciting a draft corporate regulation to the industry so that companies can provide chemical nanomaterials information to the Swedish product register by 2019.

The public solicitation period is from November 23 to March 24. The final registration date is February 28, 2019.

The agency said it would make a compilation of nanomaterials in Sweden and then consider whether any changes are needed. Eventually, the Swedish Chemicals Agency will inform the European Commission of the revised regulations.

The proposal covers nano-materials that are intentionally added to the product. Sweden, Belgium, Denmark, France and Norway require companies to provide information on nanomaterials.

11. Common cosmetic tools (such as microdermabrasion) may increase the risk of HIV transmission (2017-01-10)

Microdermabrasion, a common exfoliating way. British health officials are investigating the risks of such a way. The UK Department of Public Health follow-up reports that such a way has the possibility of a blood-borne virus, including HIV. If the staff of the blood with HIV, etc., when the needle is likely to hurt by cross-transmission to the customer. There are currently no regulatory requirements for such issues.

12. French customs found fake cosmetics! Unprecedented (2017-01-10)

French local time on January 4, the French customs came the news, open year to find a major cosmetic counterfeit case, in the outskirts of Paris, a large counterfeit laboratory was seized, several warehouses were checked.

It is reported that this counterfeit cosmetics dens is located in the Seine-et-Marne area of ​​a laboratory, investigators have been tracking the gang for several weeks. The laboratory is suspected of illegal production of facial and body care products to drug-based, the price is lower than the market price. Not only that, the laboratory also produces its own brand of cosmetics, and exports overseas. "The fake cosmetics fossa is unprecedented, not just because it engages in two counts of criminal activity, but also blatantly falsifies the origin of these cosmetic brands," the French customs authorities said.

In the seizure of the laboratory, the customs side in addition to a large number of counterfeit products, but also indirectly found a storage and transportation companies are involved in the activities involved. In the company's warehouse, the customs also seized 45,000 counterfeit products, and the same amount of cosmetic packaging, including: bottle tube, empty packaging, etc., evidence of committing the crime.

A few days later, investigators found a warehouse in the Calvados region of France, seized 17,000 counterfeit cosmetics and 50,000 empty packs. The warehouse is responsible for the manufacture and storage of managers have suspected of the case, has been handed over to the French customs judicial department.

It is reported that the French luxury goods industry in recent years continue to combat counterfeit products. The end of last year, the French police in the suburbs of Paris found a fake dens, the production of luxury goods giant LVMH three watch brand counterfeit goods, seized a total of 1.5 million euros worth of stolen goods. For the full year of 2015, the French customs seized up to 7.7 billion counterfeit goods.

America

United States

13. US Department of Environmental Protection that benzo [a] pyrene is carcinogenic to humans (2017-01-26)

The US Environmental Protection Agency conducted a toxicological review of polyacrylamide (PAH) benzo [a] pyrene, pointing out that it is carcinogenic to humans based on existing evidence. The EU stipulates that the maximum concentration of the substance is 1 ppm and 0.5 ppm for consumer and child products, respectively. In June 2016, the European Chemicals Agency (ECHA) had included the substance in the SVHC.

Asia

China

14. Shandong Provincial Food and Drug Administration 2016 Cosmetics Supervision and Inspection Information Bulletin (No. 3, No. 2016, No. 4) (2016-12-30)

Shandong Province Food and Drug Administration organized the hotel hotel with bath, skin care cosmetics supervision and sampling, according to "Cosmetics Hygienic Standard" (2007 version), detected 20 batches of substandard products. Unqualified items are methyl chloride isothiazolinone and methyl isothiazolinone and magnesium chloride and magnesium nitrate mixture.

For the above unqualified products, the provincial bureau has asked the relevant municipal authorities to check the provisions of the work, and timely issuance of verification and disposal of information.

15. Notice of the State Administration of Food and Drug Administration on Relevant Matters Concerning the Reunification of Cosmetics Production Permit (No. 12 of 2017) (2017-01-26)

According to the "Notice on the Production of Cosmetics Production Permit" (State Food and Drug Administration Notice No. 265 of 2015), the relevant matters concerning the opening of the "Cosmetics Production License" are as follows:

First, since January 1, 2017 onwards, the unified opening of "cosmetics production license." Cosmetics production enterprises to hold the original "national industrial production permit" and "cosmetics manufacturers health permit" automatically void.

Second, since January 1, 2017, did not obtain "cosmetics production license" of the cosmetics production enterprises, shall not engage in cosmetics production.

Third, the original "national industrial production permit" and "cosmetics manufacturer health permit" of the cosmetics production enterprises, its December 31, 2016 production of products can be sold to the end of the validity period.

Fourth, since July 1, 2017 production of cosmetics, must be marked with the "cosmetics production license" information on the new packaging logo.

5, the public can log on the website of the State Food and Drug Administration of cosmetics production license information management system, query cosmetics production enterprises cosmetics production license number, licensing projects, production address, legal representative, business executives, valid and other relevant information.

16. Food Cosmetics Information Not Enrolled in November 2016 (2017-01-03)

This is related to 28 cosmetics, 6 from the United Kingdom (3 due to packaging failed to return, 3 due to packaging failed to be destroyed); 19 from South Korea are returned (13 are due to the absence of imported cosmetics during the period 2 for the detection of preservatives 4-hydroxy benzoic acid methyl ester, but the product record certificate product formulations without this component, the product formula changes, did not get the corresponding 1 certificate due to the declaration and the actual product does not match the actual inspection of the product can not provide imported cosmetics record certificate); 3 from Thailand, because the packaging failed to be destroyed.

  17. Notice on soliciting the Opinions on the Information Disclosure System of the Guangdong Provincial Food and Drug Administration (Exposure Draft) (2017-01-04)

To further standardize the province's food and drug safety "exposure Taiwan" information disclosure system, the Guangdong Provincial Bureau of the "Guangdong Provincial Food and Drug Administration" exposure Taiwan "information published system (Trial)" was revised to form a "Guangdong Food and Drug Administration The "Information Disclosure System" (draft) of the "Exposure Desk" is now open to the public for comments. The public can provide feedback through the following ways and means:

18. Notice of Guangdong Provincial Food and Drug Administration on Unqualified Cosmetics (No. 4, 2016) (2017-01-10)

Guangdong Provincial Food and Drug Administration recently organized the work of cosmetics supervision and sampling work, the Guangdong Provincial Drug Inspection Institute, found marked as "beautiful blooming red freckle night cream" and other 9 batches of products there is illegal addition of prohibited substances (see Annex), are illegal products.

Guangdong Provincial Food and Drug Administration has asked: the relevant city food and drug regulatory authorities to the above enterprises to investigate, thoroughly check the substandard product batch, quantity and direction, and the relevant information to the product to the food Drug regulatory authorities; on the basis of the facts, the violation of laws and regulations in accordance with the law investigated and dealt with the crime of the transfer of public security departments to investigate criminal responsibility; investigate and deal with the results, reported to the Provincial Food and Drug Administration Cosmetics Supervision Department.

Business enterprises operating the above illegal products should immediately stop selling, on the underground frame storage, and the situation reported to the local county food and drug regulatory authorities above the county level. The storage of the shelves by the municipal food and drug regulatory authorities in the December 20, 2016 before the Provincial Food and Drug Administration cosmetics supervision office.

19. Guangdong Provincial Food and Drug Administration cosmetics production enterprises supervision and inspection results notice (2016 No. 4) (2017-01-10)

In the fourth quarter of 2016, the Provincial Food and Drug Administration carried out the province's cosmetics supervision and inspection, the main inspection of production enterprises registered product registration and production quality management, a total of 42 cosmetics manufacturers, did not fulfill the quality and safety of the main responsibility of the supervision Inspection clues have been handed over to the Municipal Food and Drug Administration for processing, is to be notified (see Annex). Guangdong Provincial Food and Drug Administration requirements, was informed that the production enterprises located in the city of food and drug regulatory authorities responsible for handling according to the law, the results of the report on January 20, 2017 before the provincial bureau.

20. Notice on the Special Supervision and Inspection Information of Cosmetics in New Year's Day in New Year's Day in 2017 in Guangdong Province (2017-01-22)

To further strengthen the supervision of cosmetics, regulate the order of the cosmetics market to ensure that the New Year's Day during the Spring Festival people use cosmetics safety, according to "issued in Guangdong Province in 2016 cosmetics supervision and sampling work plan notice" (Guangdong Food and Drug Administration [1016] No. 54 ) Requirements, the Guangdong Provincial Food and Drug Administration organized the festival to carry out special supervision and sampling of the cosmetics market. The province completed a total of 38 batches of special supervision and sampling, the results are qualified (see Annex). Is hereby notified.

21. Notice of the Guangdong Provincial Food and Drug Administration on matters relating to the registration of domestic special-purpose cosmetics (2017-01-25)

  All levels to the market, Shunde District Food and Drug Administration, the provincial bureau review and certification center, the relevant units:

(Hereinafter referred to as "No.53"), and in conjunction with the actual situation of our province, it is relevant to the relevant matters (hereinafter referred to as the "Notice on the Procedures for the Registration of Related Specialties for Cosmetics for Special Purpose Cosmetics" The notification is as follows:

One, 503, three cases of the scene inspection, mainly around the production enterprise quality management system to run the situation, on-site inspection records (see Annex 1). The city bureau and the provincial bureau review and certification center 30 working days to complete the on-site inspection and submitted to the provincial bureau, such as the commissioned party sampling failed, in addition to the on-site inspection of the entrusted party, must submit product quality failure analysis report. On-site inspection can apply before the declaration to the provincial bureau, can also submit "to order correction notice" and check the relevant records, such as inspection can be exempt from registration at the time of registration. Three kinds of circumstances to conduct a on-site inspection, to declare "domestic special purpose cosmetics manufacturers health conditions audit", "domestic special purpose cosmetics production, listing supervision audit" to submit a copy of the site inspection records.

22. Notice on the Administration of Importing Non-Special Purpose Cosmetics for the Pilot Project in Pudong New Area, Shanghai (No. 7 of 2017) (2017-01-17)

In order to implement the "Decision of the State Council on the Provisional Adjustment of the Administrative Regulations and the Administrative Examination and Approval of the State Council Documents in the Pudong New Area of ​​Shanghai" (Guo Fa [2016] No. 24), it is now in the Pudong New Area, Shanghai, Special purpose cosmetics for the record management and other matters related to the announcement as follows:

First, from March 1, 2017 to December 21, 2018, where the import from the Shanghai Pudong New Area port, and the territory of the person in charge of registration in Shanghai Pudong New Area for the first time the import of non-special purpose cosmetics, adjusted by the current approval management For the record management. Import cosmetics production enterprises and their responsible persons should be in the product before the import, for the first time the import of non-special purpose cosmetics for the record.

Second, the first import non-special purpose cosmetics for filing through the filing system implementation, in the record system to obtain the record before the import trade.

Third, has been in accordance with the requirements of this announcement for the first time for the record of imported products, follow-up needs from the Shanghai Pudong New Area outside the port of imports, should be canceled for the record product information, in accordance with the existing "Cosmetics Hygiene Supervision Regulations" provides access to cosmetics for the first time import administrative approval Before the import.

Fourth, food and drug regulatory authorities and entry and exit inspection and quarantine departments should strengthen coordination and timely notification of product quality and safety information, together with the relevant departments to crack down on illegal activities. Responsible for the implementation of the record management of food and drug regulatory authorities should be responsible for the import and export inspection and quarantine supervision and management of the entry and exit inspection and quarantine departments have been informed of the record enterprise and product-related information, entry and exit inspection and quarantine departments to verify the record vouchers.

Notice of the General Administration of the People 's Republic of China on Issuing the Work Procedure for the Administration of the Importation of Non - special - purpose Cosmetics for the Pudong New Area of ​​Shanghai (Temporary) (No. 10 of 2017) (2017-01-18)

In order to conscientiously implement the "State Council on the Shanghai Pudong New Area to temporarily adjust the relevant administrative regulations and the State Council documents on the administrative examination and approval of the matter" (Guo Fa 〔2016〕 24) requirements, the State Food and Drug Administration has developed a "Shanghai Pudong New Area, the import of non-special purpose cosmetics filing management procedures (provisional) ", is to be released.

23. Notice of the General Administration of 29 batches of disinfection of acne cosmetics (No. 9 of 2017) (2017-01-18)

State Food and Drug Administration in the nationwide organization to carry out the cosmetics supervision and sampling, a total of 2717 batches of acne products, seized 29 batches of substandard products. The discovery of 29 batches of acne cosmetics there is illegal addition of prohibited substances. The relevant information is hereby notified as follows:

29 batches of products are detected containing ofloxacin, metronidazole, chloramphenicol and other antibiotics drugs. Long-term exposure to antibiotics containing cosmetics, easy to cause contact dermatitis, antibiotic allergy and other symptoms, easy to produce drug resistance. Drug residues may also lead to poisoning, allergic reactions. Cosmetics Hygienic Standard (2007 edition) and Cosmetic Safety Technical Specification (2015) provide for the use of banned substances in cosmetics.

Guangdong Province, Shanghai, Gansu Province Food and Drug Administration is the nominal production enterprises to investigate violations. The State Food and Drug Administration requires the provincial (city) Food and Drug Administration to immediately order enterprises to recall nonconforming products, on the basis of the facts, the enterprise law and regulations in accordance with the law investigated and dealt with; suspected of criminal, timely transfer of the judiciary deal with. The provincial and municipal food and drug supervision and administration authorities shall report the results of the State Food and Drug Administration and report to the public before February 20, 2017.

Cosmetics business users should immediately stop selling the use of the underground frame to seal the above substandard products, and the situation reported to the local people's governments above the county level food and drug regulatory authorities. The storage and investigation of the underground shelves by the provincial food and drug regulatory authorities in the February 20, 2021 before the State Food and Drug Administration.

Korea

24. Korea is expected to ban animal testing in 2017 (2017-01-04)

February 3, 2016, South Korea officially released "cosmetic law part of the amendment bill." According to the provisions of the amendment bill, after animal production and manufacture of cosmetics and cosmetics raw materials products, will not be circulation and sales. Article 15 (2) prohibits the circulation of cosmetics through animal experiments, etc.) also provides that after animal production of cosmetics and cosmetics raw materials products, will not be circulation and sales. But when applicable to national health needs and individual reasons, through the relevant evaluation can be applied.

Korea "Cosmetic Law Partial Amendment Act" will be implemented on February 4, 2017. South Korea will ban the production or import of cosmetics in the country, including commissioned by animal experiments. The ban applies to alternative tests previously received by the Korea Food and Drug Administration (MFDS). South Korea's ban exemption includes: toxicology endpoints still allow animal testing, such as repeated dose toxicity, skin irritation, skin and eye irritation, as there is no alternative test currently accepted by MFDS. After the commencement of the bill, if there is a violation, will be sentenced to 1 million won less than the fine.

In 2014, India highlighted the ban on animal testing and became the first country in Asia to ban animal testing. In 2015, New Zealand issued an animal test ban; in 2016, Taiwan released an animal test ban. Following India, South Korea will become the second country in Asia to prohibit the prohibition of cosmetics for animal testing.

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