Transition from NICNAS to AICIS finishes today (31st August 2022). <\/p>\n\n\n\n
In many cases Introducers have not managed to meet the AICIS categorisation and record keeping requirements during the two year transition from NICNAS to AICIS. <\/p>\n\n\n\n
AICIS has announced some new provisions to assist with the transition from the 1st of September 2022. These provisions are as follows; If you are experiencing any issues with the transition from NICNAS to AICIS or have encountered issues with compliance post transition, please contact Seren for advice and assistance. <\/p>\n\n\n\n Is your cosmetic considered a therapeutic good in Australia? <\/u><\/strong><\/p>\n\n\n\n Products that\nare considered cosmetics in other jurisdictions may be considered therapeutics in\nAustralia based on the following factors <\/strong><\/p>\n\n\n\n Therefore, advertising\nmaterial may result in the product being considered a therapeutic good in\nAustralia. <\/strong><\/p>\n\n\n\n The TGA has\nreleased a learning resource regarding the effect of advertising material and product\nclaims on the regulatory pathway.<\/strong><\/p>\n\n\n\n Advertising:\nwhen cosmetics are regulated as therapeutic goods | Therapeutic Goods\nAdministration (TGA)<\/a><\/p>\n\n\n\n Please\ncontact Seren for advice and assistance with cosmetic regulatory matters.<\/strong><\/p>\n\n\n\n AICIS Post Introduction Declarations\nare now due. <\/u><\/strong><\/p>\n\n\n\n If your introduction is one of the\nfollowing; <\/strong><\/p>\n\n\n\n polymers of low concern<\/strong><\/p>\n\n\n\n low-concern biopolymers<\/strong><\/p>\n\n\n\n chemicals that you have categorised as very low risk for human health\nand the environment<\/strong><\/p>\n\n\n\n Then a one-off Post Introduction Declaration (PID) is required following the first introduction of the chemical to Australia. Declarations may be submitted via the AICIS Business Services Portal. <\/strong><\/p>\n\n\n\n This PID is due by the 30th<\/sup> of November 2021 and it covers the period of the 1st<\/sup><\/strong> of July 2020 to the 31st<\/sup> of August 2021. <\/strong><\/p>\n\n\n\n The PID is separate<\/em> to the Annual Declaration and is only required once. <\/strong><\/p>\n\n\n\n Please contact Seren for advice and assistance with Post Introduction\nDeclarations. <\/strong><\/p>\n\n\n\n Reminder – AICIS Annual Declarations are now due.<\/u><\/strong><\/p>\n\n\n\n All Australian importers and manufacturers of chemicals are required to submit an annual declaration via the AICIS Business Services Portal. The declaration form is now available. <\/strong><\/p>\n\n\n\n The registration year runs from the 1st<\/sup> of September\nto the 31st<\/sup> of August. With\nthe declaration deadline of the 30th<\/sup> of November. <\/strong><\/p>\n\n\n\n Please contact Seren for advice with annual declarations. <\/strong><\/p>\n\n\n\n New Zealand implementation of GHS 7 takes effect on the 30th<\/sup> of April 2021 \u2013 implications for existing substances with Individual Approvals or under a 2017 Group Standard.<\/u><\/strong><\/p>\n\n\n\n New Zealand\u2019s updated hazard classification system comes into effect\nin three weeks\u2019 time. This new system is in line with GHS 7 and\nreplaces the 2001 HSNO classification system. \n<\/strong><\/p>\n\n\n\n There is a 4-year transition period for those substances with\ncurrent Individual Approvals and for those under an existing Group Standard. <\/strong><\/p>\n\n\n\n Recently the NZ EPA revoked more than 5000 Individual Approvals. These substances are now covered by Group Standards.\nReassigned substances will require updated self-assignment records. <\/strong><\/p>\n\n\n\n If you believe your substances is covered by an Individual Approval,\nplease contact Seren to confirm and for advice. \n<\/strong><\/p>\n\n\n\n Some Group Standards have updated scopes, i.e.,\naerosol group standards. Therefore, it\nis recommended that substances assigned to existing Group Standards are reviewed\nand, if required, assigned to a more appropriate updated Group Standard. <\/strong><\/p>\n\n\n\n Please contact Seren for advice or review of existing\napprovals either Individual or Group Standard Approvals. <\/strong><\/p>\n\n\n\n Alcohol Based Hand Sanitisers \u2013 New ACCC Standard for labelling<\/u><\/strong><\/p>\n\n\n\n The new Consumer Goods (Cosmetics) Information Standard 2020 was created this week and took effect on the 25th of November 2020. \n\n\n\n Section 11 of this standard outlines specific labelling requirements for alcohol based hand sanitisers that meet the definition of a \u2018cosmetic\u2019. <\/p>\n\n\n\n \u2018Alcohol\u2019 has been defined in the standard as;<\/p>\n\n\n\n includes, but is not limited to, ethyl alcohol (ethanol), isopropyl alcohol and alcohol denat.<\/p>\n\n\n\n The standard has a 180-day transitional period ending on the 23rd of May 2021. <\/p>\n\n\n\n Please contact Seren for advice or review of labels for cosmetics including hand sanitising products.<\/p>\n\n\n\n GHS 7 \u2013 Safework Australia update the model Work Health and Safety Regulations (Hazardous Chemicals) Amendment 2020<\/u><\/strong><\/p>\n\n\n\n Australia will begin the two-year transition to GHS 7 from\nJanuary 1 2021. <\/strong><\/p>\n\n\n\n The model Work Health and Safety Regulations (Hazardous\nChemicals) Amendment 2020 and the explanatory statement published in August\n2020 have been updated. These updates\ninclude rectifying the requirement to re-label historical stock in certain\ncircumstances. <\/p>\n\n\n\n Please contact Seren for advice or assistance regarding the transition to GHS 7 <\/p>\n\n\n\n Australian TGA Post-market review of face masks<\/u><\/strong><\/p>\n\n\n\n Face masks which meet the definition of a medical device must be\nincluded on the Australian Register of Therapeutic Goods (ARTG) prior to\nsupply. Such masks are those that are intended to protect the wearer from the spread of disease, illness, and infection. <\/p>\n\n\n\n The global pandemic resulted in a greater demand for such face masks\nand thus an increase in class I medical device listings on the ARTG. Additionally, face masks were included under\nan emergency exemption to support the National Medical Stockpile, resulting in an increase in importation and manufacture of face masks. <\/p>\n\n\n\n The Australian Therapeutic Goods Administration (TGA) is\nundertaking a post-market review of face masks that are included on the ARTG, including those introduced to support the stockpile. This review is resulting in the cancellation of ARTG listings. <\/p>\n\n\n\n Suppliers of face masks are responsible for ensuring all\nregulatory requirements are met. Including conformity of the product. <\/p>\n\n\n\n Please contact Seren for further information on\nthe evidence that must be available when sponsoring a listed medical device or if you have any concerns regarding an ARTG listing. <\/p>\n\n\n\n APVMA \u2013 Pack size variations<\/u><\/strong><\/p>\n\n\n\n The APVMA have advised that the variation of pack sizes\nconstitutes a \u2018change to the relevant particulars\u2019 of a registered\nproduct. Such changes require a Notifiable Variation (NV) application. <\/p>\n\n\n\n This can be avoided by registering pack sizes as a range rather\nthan discrete packs during the original registration. <\/p>\n\n\n\n If you would like assistance with pack size variations or would\nlike to alter the registered pack sizes to a range, please contact Seren for advice.<\/p>\n\n\n\n Medical Device Post-market Reviews<\/u><\/strong><\/p>\n\n\n\n The Australian Therapeutic Goods Administration (TGA) has developed a new Post Market Review Compliance Dashboard as a process of responding to a post-market review and sending associated documentation.<\/p>\n\n\n\n Launching on the 19th of October 2020, this new dashboard may be accessed via the TBS and provides a single point to access the reviews (open and closed) and upload required information.<\/p>\n\n\n\n Please contact Seren for further information on how we can assist with medical device post market review. <\/p>\n\n\n\n APVMA Advice on Product and Label Variations.<\/u><\/strong><\/p>\n\n\n\n The Australian Pesticides and Veterinary Medicines Authority (APVMA) has provided advice regarding the types of product or label updates that can be made without requiring APVMA application or notification.<\/p>\n\n\n\n Such variations should not impact on the registration particulars or condition and may include the following;<\/p>\n\n\n\n Please contact Seren for further information on how we can assist with APMVA label variations. <\/p>\n\n\n\n AICIS launches new website <\/u><\/strong><\/p>\n\n\n\n Australian Industrial\nChemicals Introduction Scheme (AICIS) commenced on the 1st<\/sup> of July\n2020. <\/strong><\/p>\n\n\n\n Therefore, AICIS has\nnow launched a new website <\/strong><\/p>\n\n\n\n https:\/\/www.industrialchemicals.gov.au\/<\/a><\/p>\n\n\n\n This website allows\nsearching of the Australian Inventory of Industrial Chemicals (the Inventory). <\/strong><\/p>\n\n\n\n Please contact Seren\nfor further information on how we can assist with AICIS compliance and\ninventory searching. <\/strong><\/p>\n\n\n\n AICIS record keeping obligations <\/u><\/strong><\/p>\n\n\n\n AICIS has compliance\n\u2013 monitoring activity and enforcement powers that are different to those that existed\nunder NICNAS. <\/strong><\/p>\n\n\n\n AICIS has identified\nthat some introducers are not able to readily produce evidence that they are\nmeeting the record keeping obligations. \nIn particular, evidence of importation volumes. <\/strong><\/p>\n\n\n\n AICIS are encouraging\nIntroducers to have written agreements in place with agents and manufacturers to\nprove they\u2019re lawfully importing or manufacturing industrial chemicals. <\/strong><\/p>\n\n\n\n Please contact Seren\nfor further information on how we can assist with record keeping and\nagreements. <\/strong><\/strong><\/p>\n\n\n\n NICNAS Reforms \u2013 Are\nyou AICIS ready? <\/u><\/strong><\/p>\n\n\n\n The new regulatory\nscheme will commence on the 1st<\/sup> of July 2020. <\/strong><\/p>\n\n\n\n The AICIS\nCategorisation process is unique and there is rarely a straightforward\ncomparison between a NICNAS permit or exemption and an AICIS category. <\/strong><\/p>\n\n\n\n Transition periods\nare in place for chemicals introduced under current exemptions and\npermits. <\/strong><\/p>\n\n\n\n Please contact Seren\nfor further information on the transitional arrangements and how we can assist\nwith categorisation under AICIS. <\/strong><\/p>\n\n\n\n Hard Surface Disinfectants\nand Hand Sanitisers and COVID – 19.<\/u><\/strong><\/p>\n\n\n\n The regulation of\nhard surface disinfectants in Australia has increased interest due to the\nCOVID-19 situation. <\/strong><\/p>\n\n\n\n The TGA has updated\nthe instructions for disinfectant testing to include the relevant surrogate\nviruses for use in disinfectant efficacy tests to justify claims against\nCOVID-19. <\/strong><\/p>\n\n\n\n Additionally, the TGA\nare expediating disinfectant applications which have claims relating to\nCOVID-19. <\/strong><\/p>\n\n\n\n Hand sanitisers with\nspecific claims (including viricidal claims) are considered therapeutic goods\nthat require inclusion on the Australian Register for Therapeutic Goods (ARTG)\nunless subject to specific exemptions. <\/strong><\/p>\n\n\n\n In response to the\nCOVID-19 situation the TGA released the Therapeutic Goods (Excluded Goods \u2013\nHand Sanitisers) determination 2020. \nThis determination details specific formulation and requirements which\nwill exclude specific hand sanitiser formulations from the Therapeutic Goods\nLegislation. Such products may make\nspecific claims yet will be regulated as consumer goods. <\/strong><\/p>\n\n\n\n Please contact Seren\nfor further details and assistance with meeting the regulatory requirements for\nhard surface disinfectants and hand sanitisers. \n<\/strong><\/p>\n\n\n\n NICNAS\nReforms \u2013 Early Regulatory Changes are now in effect.<\/u><\/strong><\/p>\n\n\n\n The new\nregulatory scheme will commence on the 1<\/strong>st<\/strong><\/sup>\nof July 2020. However early regulatory changes are now in effect. \nThese changes are intended to reduce the regulatory burden for\ncertain \u2018low risk\u2019 chemicals. These changes include the\nfollowing; <\/strong>\n<\/p>\n\n\n\n Please contact Seren for further information and conditions of the above early changes. <\/strong> <\/p>\n\n\n\n Standard\nfor Disinfectants and Sanitary Products \u2013 Therapeutic Goods Order\n104.<\/u><\/strong><\/p>\n\n\n\n Therapeutic\nGoods Order (TGO) 54 \u2018Standard for Disinfectants and sterilants\u2019\nhas been replaced with TGO 104: standard for Disinfectants and\nSanitary Products. <\/strong>\n<\/p>\n\n\n\n Additionally\nthe TGA has separated out the schedules of the obsolete TGO 54, and\nmade them available as the TGA instructions for disinfectant testing.\n <\/strong>\n<\/p>\n\n\n\n Additional changes and further guidance\u2019s are expected throughout 2019. If you would like further information please contact Seren. <\/strong><\/p>\n\n\n\n Country\nof origin labelling for complementary healthcare products<\/u><\/strong><\/p>\n\n\n\n The Australian\nCompetition and Consumer Commission (ACCC) has released a guidance\nfor the complimentary healthcare industry to inform how the safe\nharbor defences under the Australian Consumer Law applies to their\nproducts. <\/strong>\n<\/p>\n\n\n\n This new\nguidance clearly describes the obligations under section 255 of the\nAustralian Consumer Law. <\/strong>\n<\/p>\n\n\n\n If you would\nlike further information please contact Seren. <\/strong>\n<\/p>\n\n\n\n <\/p>\n","protected":false},"excerpt":{"rendered":" Transition from NICNAS to AICIS finishes today (31st August 2022). In many cases Introducers have not managed to meet the AICIS categorisation and record keeping requirements during the two year transition from NICNAS to AICIS. AICIS has announced some new provisions to assist with the transition from the 1st of September 2022. These provisions are … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":1,"featured_media":178,"parent":0,"menu_order":0,"comment_status":"open","ping_status":"closed","template":"","meta":[],"_links":{"self":[{"href":"http:\/\/www.serenconsulting.com.au\/en\/wp-json\/wp\/v2\/pages\/57"}],"collection":[{"href":"http:\/\/www.serenconsulting.com.au\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"http:\/\/www.serenconsulting.com.au\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"http:\/\/www.serenconsulting.com.au\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"http:\/\/www.serenconsulting.com.au\/en\/wp-json\/wp\/v2\/comments?post=57"}],"version-history":[{"count":25,"href":"http:\/\/www.serenconsulting.com.au\/en\/wp-json\/wp\/v2\/pages\/57\/revisions"}],"predecessor-version":[{"id":316,"href":"http:\/\/www.serenconsulting.com.au\/en\/wp-json\/wp\/v2\/pages\/57\/revisions\/316"}],"wp:featuredmedia":[{"embeddable":true,"href":"http:\/\/www.serenconsulting.com.au\/en\/wp-json\/wp\/v2\/media\/178"}],"wp:attachment":[{"href":"http:\/\/www.serenconsulting.com.au\/en\/wp-json\/wp\/v2\/media?parent=57"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
1. Listed introductions – transition period extended<\/strong>
AICIS requires that certain records be kept for ‘Listed Introductions’. These records must include the identity of the chemical or a ‘Written Undertaking’ from the chemical supplier. AICIS have extended the timeframe to meet these requirements until the 30th of November 2023<\/strong>.
Until this date, AICIS will accept either the written confirmation that the introducer would have had under NICNAS confirming that the chemical is listed on the Australian Inventory of Chemical Substances (NICNAS inventory) or copies of correspondence to show that a ‘Written Undertaking’ has been requested to meet the AICIS requirements.
2. Low volume introductions of chemicals \u2013 changes to the Rules will be proposed<\/strong>\u00a0
AICIS will conduct a consultation shortly regarding proposed changes to the Industrial Chemicals (General) Rules 2019 (the Rules) for introductions of chemicals at less than or equal to 10 kg in a registration year.\u00a0
It is expected that these changes will not <\/strong>be a simple de minimis<\/em> exclusion for 10 kg.
3. Other changes – chemicals previously introduced under the NICNAS exemptions\u00a0<\/strong>
There will be no extension for the transition of certain NICNAS exemptions to AICIS. <\/strong><\/em>
AICIS have announced that they will conduct the following activities; <\/p>\n\n\n\n
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