{"id":294,"date":"2025-03-06T02:52:27","date_gmt":"2025-03-06T02:52:27","guid":{"rendered":"https:\/\/mocra.reach24h.com\/index.php\/home-%e6%97%a5%e6%9c%ac%e8%aa%9e\/"},"modified":"2025-03-20T07:58:38","modified_gmt":"2025-03-20T07:58:38","slug":"japan","status":"publish","type":"page","link":"https:\/\/mocra.reach24h.com\/index.php\/japan\/","title":{"rendered":"Home – \u65e5\u672c\u8a9e"},"content":{"rendered":"\t\t
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US FDA Cosmetic Regulation: MoCRA<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Enacted on December 29, 2022, the Modernization of the Cosmetics Regulation Act of 2022 (MoCRA) is the first major overhaul of the Federal Food, Drug and Cosmetic Act for cosmetics regulation since its passage in 1938, modernizing the country\u2019s cosmetic regulatory framework to meet current needs. <\/p>

REACH24H specializes in cosmetic regulatory compliance, offering comprehensive support to ensure your business aligns with US MoCRA requirements.<\/span><\/p><\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tContact us<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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US Cosmetic Compliance Guide<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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US FDA Cosmetic Facility Registration<\/a><\/h4>

Under US MOCRA, any facility that manufactures or processes cosmetics for the U.S. market\u2014whether domestic or foreign\u2014must register with the FDA, including contract manufacturers.<\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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US FDA Cosmetic Product Listing<\/a><\/h4>

The manufacturer, packer, or distributor of a cosmetic product\u2014whose name appears on the label\u2014is required to list every marketed cosmetic product, including its ingredients, with the FDA.<\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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US FDA Cosmetic Labeling Requirements<\/h4>

US MoCRA extends the requirements, requesting cosmetic responsible persons to provide additional labeling details.<\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Responsible Person & US Agent<\/h4>

Every cosmetic product introduced to the US market must have a designated a Responsible Person, who can be the manufacturer, packager, or distributor listed on the product label. <\/p><\/div><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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News & Insights<\/span><\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\n\t\t\t\tNavigating U.S. FDA OTC and Cosmetic Regulations: A Comprehensive Guide\t\t\t<\/a>\n\t\t<\/h3>\n\t\t\t\t
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Introduction The regulato<\/p>\n\t\t<\/div>\n\t\t\n\t\t\n\t\t\tRead More \u00bb\t\t<\/a>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/article>\n\t\t\t\t

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\u898f\u5236\u306e\u80cc\u666f \u7c73\u56fd\u306e\u5316\u7ca7\u54c1\u306b\u95a2\u3059\u308b\u6cd5\u5f8b\u306f\u3001\u9023\u90a6\u898f\u5236\u3068<\/p>\n\t\t<\/div>\n\t\t\n\t\t\n\t\t\tRead More \u00bb\t\t<\/a>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/article>\n\t\t\t\t

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\n\t\t\t\n\t\t\t\t\u7c73\u56fdFDA MoCRA\u306b\u57fa\u3065\u304f\u5316\u7ca7\u54c1\u30ea\u30b9\u30c8\u63d0\u51fa\u65b9\u6cd5\t\t\t<\/a>\n\t\t<\/h3>\n\t\t\t\t
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\u7c73\u56fdFDA MoCRA\u6cd5\u898f\u306e\u80cc\u666f 2022\u5e7412\u6708<\/p>\n\t\t<\/div>\n\t\t\n\t\t\n\t\t\tRead More \u00bb\t\t<\/a>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/article>\n\t\t\t\t

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\n\t\t\t\n\t\t\t\t\u30bf\u30a4\u3001ASEAN\u5316\u7ca7\u54c1\u6307\u4ee4\u306e\u6539\u5b9a\u306b\u5408\u308f\u305b\u3001\u5316\u7ca7\u54c1\u898f\u5236\u3092\u5f37\u5316\t\t\t<\/a>\n\t\t<\/h3>\n\t\t\t\t
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2024\u5e747\u670811\u65e5\u3001\u30bf\u30a4\u98df\u54c1\u533b\u85ac\u54c1\u5c40( FDA)<\/p>\n\t\t<\/div>\n\t\t\n\t\t\n\t\t\tRead More \u00bb\t\t<\/a>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/article>\n\t\t\t\t

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\n\t\t\t\n\t\t\t\tUnderstanding US Cosmetics GMPs Requirements Under MoCRA\t\t\t<\/a>\n\t\t<\/h3>\n\t\t\t\t
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In the US cosmetics indus<\/p>\n\t\t<\/div>\n\t\t\n\t\t\n\t\t\tRead More \u00bb\t\t<\/a>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/article>\n\t\t\t\t

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\n\t\t\t\n\t\t\t\t\ubbf8\uad6d FDA MoCRA \uc81c\uc870 \uc2dc\uc124 \ub4f1\ub85d \ud544\uc218 \uac00\uc774\ub4dc: \uc808\ucc28, \uc11c\ub958, \uba74\uc81c \uc870\uac74 \ucd1d\uc815\ub9ac!\t\t\t<\/a>\n\t\t<\/h3>\n\t\t\t\t
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\ubbf8\uad6d FDA MoCRA \ubc95\uaddc \ubc30\uacbd 2022\ub144 <\/p>\n\t\t<\/div>\n\t\t\n\t\t\n\t\t\tRead More \u00bb\t\t<\/a>\n\n\t\t\t\t<\/div>\n\t\t\t\t<\/article>\n\t\t\t\t<\/div>\n\t\t\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Resources<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tGuidance on Registration and Listing of Cosmetic Product Facilities and Products\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\tIn force \uff5c Release Date: 2024-12-11\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tUser's Guide to FDA Direct (Cosmetics Direct)\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\tIn force \uff5c Release Date: 2024-12-11\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tStructured Product Labeling (SPL) Implementation Guide with Validation Procedures\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\tIn force \uff5c Release Date: 2024-12-11\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tCompliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\tIn force \uff5c Release Date: 2024-12-11\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tCalifornia State: Updates to 2020 Toxic-Free Cosmetics Act\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\tIn force \uff5c Release Date: 2024-12-11\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tCalifornia State: Listing Nail Products Containing Toluene as a Priority Product\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t

\n\t\t\t\t\t\tIn force \uff5c Release Date: 2024-12-11\t\t\t\t\t<\/p>\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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FAQ<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tdown<\/title><\/rect><\/path><\/g><\/g><\/g><\/svg><\/span>\n\t\t\t\t\t\t\t\tup<\/title><\/rect><\/path><\/g><\/g><\/g><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\tFor contract manufacturing cases, who should register the facility?<\/a>\n\t\t\t\t\t<\/h4>\n\n\t\t\t\t\t

The commissioning party\/brand owner can register the facility. Even if the contracted enterprise manufactures its own products or produces for other commissioning parties at the same time, repeated registration is not required.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t

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\n\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tdown<\/title><\/rect><\/path><\/g><\/g><\/g><\/svg><\/span>\n\t\t\t\t\t\t\t\tup<\/title><\/rect><\/path><\/g><\/g><\/g><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\tDo factories engaged in the production and processing of cosmetic raw materials need to register?<\/a>\n\t\t\t\t\t<\/h4>\n\n\t\t\t\t\t

At this stage, the FDA requires that factories involved in the production and processing related to the final cosmetic formula (including cases where the final formula consists of only one raw material) must register. Regarding product listing, the FDA expects that the responsible party lists only those products that are marketed to end users (such as the general public or professionals).<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t

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\n\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tdown<\/title><\/rect><\/path><\/g><\/g><\/g><\/svg><\/span>\n\t\t\t\t\t\t\t\tup<\/title><\/rect><\/path><\/g><\/g><\/g><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\tDo importers need to register the facility or list products?<\/a>\n\t\t\t\t\t<\/h4>\n\n\t\t\t\t\t

\u00a0If an importer meets the definition of a facility or product responsible person and does not fall within the exempted category, then the importer must proceed with the relevant facility registration or product listing. Otherwise, the importer is not required to take such actions.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t

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\n\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tdown<\/title><\/rect><\/path><\/g><\/g><\/g><\/svg><\/span>\n\t\t\t\t\t\t\t\tup<\/title><\/rect><\/path><\/g><\/g><\/g><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\tDo laboratories that conduct testing solely for cosmetic research and development need to register as a facility?<\/a>\n\t\t\t\t\t<\/h4>\n\n\t\t\t\t\t

No, they do not. If a laboratory’s tests are solely for R&D or evaluation of cosmetics, rather than for retail purposes, then the laboratory is not required to register as a facility.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t

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\n\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tdown<\/title><\/rect><\/path><\/g><\/g><\/g><\/svg><\/span>\n\t\t\t\t\t\t\t\tup<\/title><\/rect><\/path><\/g><\/g><\/g><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\tWill product listing information be made public?<\/a>\n\t\t\t\t\t<\/h4>\n\n\t\t\t\t\t
According to the draft guidance, the FDA will not disclose the product listing number or details of the manufacturing and processing enterprise corresponding to the product. All other relevant information will be made public.<\/div><\/div><\/div><\/div><\/div><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t
\n\t\t\t\t\t

\n\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tdown<\/title><\/rect><\/path><\/g><\/g><\/g><\/svg><\/span>\n\t\t\t\t\t\t\t\tup<\/title><\/rect><\/path><\/g><\/g><\/g><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\tDo hair dyeing preparations (including hair dyes) need to be listed?<\/a>\n\t\t\t\t\t<\/h4>\n\n\t\t\t\t\t

Yes. Unless they qualify for an exemption, hair dyeing preparations, including hair dyes, must be listed.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t

\n\t\t\t\t\t

\n\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tdown<\/title><\/rect><\/path><\/g><\/g><\/g><\/svg><\/span>\n\t\t\t\t\t\t\t\tup<\/title><\/rect><\/path><\/g><\/g><\/g><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\tHow is the receiving date determined for registrations and listings submitted via paper forms?<\/a>\n\t\t\t\t\t<\/h4>\n\n\t\t\t\t\t

When the FDA receives paper-submitted documents, a receiving date is assigned. This receiving date is the date on which the submission is actually delivered to the designated receiving unit (the address specified on the paper form) during normal business hours.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t

\n\t\t\t\t\t

\n\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tdown<\/title><\/rect><\/path><\/g><\/g><\/g><\/svg><\/span>\n\t\t\t\t\t\t\t\tup<\/title><\/rect><\/path><\/g><\/g><\/g><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\tDo importers need to list products?<\/a>\n\t\t\t\t\t<\/h4>\n\n\t\t\t\t\t

If an importer meets the definition of a facility or product responsible person and does not fall within the exemption criteria, the importer is required to submit the relevant product listing. Otherwise, the importer is not required to take such action.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t

\n\t\t\t\t\t

\n\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tdown<\/title><\/rect><\/path><\/g><\/g><\/g><\/svg><\/span>\n\t\t\t\t\t\t\t\tup<\/title><\/rect><\/path><\/g><\/g><\/g><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\tDo laboratories that perform batch release testing for cosmetics need to register as a facility?<\/a>\n\t\t\t\t\t<\/h4>\n\n\t\t\t\t\t

Yes, they do. Batch release testing is considered a part of the product’s manufacturing process, so such laboratories are required to register as a facility.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t

\n\t\t\t\t\t

\n\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\tdown<\/title><\/rect><\/path><\/g><\/g><\/g><\/svg><\/span>\n\t\t\t\t\t\t\t\tup<\/title><\/rect><\/path><\/g><\/g><\/g><\/svg><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\tDo free samples or gifts require product listing submission?<\/a>\n\t\t\t\t\t<\/h4>\n\n\t\t\t\t\t

Generally, yes, they require submission. While factories providing free cosmetics at trade shows or other events may be exempt from facility registration under section 604(3) of the FD&C Act, the product listing requirement still applies to cosmetics provided free of charge to consumers.<\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

US FDA Cosmetic Regulation: MoCRA Enacted on December 2 […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_seopress_robots_primary_cat":"","_seopress_titles_title":"","_seopress_titles_desc":"","_seopress_robots_index":"","footnotes":""},"class_list":["post-294","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/mocra.reach24h.com\/index.php\/wp-json\/wp\/v2\/pages\/294","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mocra.reach24h.com\/index.php\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/mocra.reach24h.com\/index.php\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/mocra.reach24h.com\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/mocra.reach24h.com\/index.php\/wp-json\/wp\/v2\/comments?post=294"}],"version-history":[{"count":6,"href":"https:\/\/mocra.reach24h.com\/index.php\/wp-json\/wp\/v2\/pages\/294\/revisions"}],"predecessor-version":[{"id":1185,"href":"https:\/\/mocra.reach24h.com\/index.php\/wp-json\/wp\/v2\/pages\/294\/revisions\/1185"}],"wp:attachment":[{"href":"https:\/\/mocra.reach24h.com\/index.php\/wp-json\/wp\/v2\/media?parent=294"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}