Full Notification

All substances which are not Hsted in EINECS [5-1] (European Inventory of foisting Commercial Substances) have to be notified in accordance with Substance Directive 67/548/EEC [5-2] to the competent authority of the member state of the European Community in which the substance is manufactured or in which the importer has been estabhshed 60 days before the first placing on the market. 

Furthermore, the notifier has to inform the competent authorities when the quantity of the substance placed on the market reaches 

Requirements for the notification are reduced if the quantities placed on the market are less than one torme per aimum (see Section 5.2 for details). 

In the case of substances which were notified more than ten years previously, the notifier has only to submit information about the identity of substance, the production method, and uses. 

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Full notification is required 60 days before a substance is to be supplied in the EU at an amount of above 1 tonne per annum (or 5 tonnes cumulative). Notification... 

Commercial evaluation permit This is a permit which can be obtained for a maximum of 2 years and for a maximum of 4000 kg of the chemical or polymer. This permit is usually obtained as a precursor to one of the main notification categories above. The intention is to evaluate the market feasibility of the chemical before committing to a full notification. Chemicals which are used in consumer end-use products do not qualify for this permit 14... 

Industry must generate data on their own chemicals, and assign appropriate hazard and safety classifications in accordance with guidelines laid out in the Directive. Summaries of the infcMmation must be provided to the Commission, and subsequently to other Member States. The United Kingdom currently receives aj roximately 70 full notifications each year [6]. About 40% of these have been classified as dangerous to health in some way. 

New chemical notification schemes vary considerably between countries, but many base the studies for full notification on the OECD minimum pre-maiketing set of data (MPD) the EC, certain EFTA countries, Australia and the imminent Canadian scheme (See Table 34.1). Only a few studies additional to the EC Base Set are needed fw full notification in Austria and Switzerland. Chemical control legislation in Scandinavia is in the iwocess of being changed, in order to achieve the intended harmonization by 1 January 1995 of chemical control legislation between the EC and 6 of the EFTA countries under the new European Economic Area (EEA). The EC notification scheme will have been updated by then, under the Seventh Amendment Council Directive 92/32/EEC [12], which was brought into force by 31 October 1993. Thus the current Finnish new chemicals notification scheme will be modified to confoim exactly to that of Council Directive 92 2/EEC as from 31 October 1993, and the proposed notification schemes for Norway and Sweden will also have to be in harmony with the EC. 

The MPD is tecommended by the OECD for adequate hazard assessment of new chemical substances. Full notification for supply in the EC at 1 tonne a (or S tonnes cumulative) under the Seventh Amendment Council Directive 92/32/EEC [12], Note that a screening test for toxicity to reproduction will ako be required as part of the Base Set when a snitaUe method has been developed. 

Full notification is required for substances supplied >1 tonne a . The review period is 3 months, which may be stopped by the authorities fw a deficient notification and begun again at day 1 only when the omitted data are provided. Notification may also be required if the total annual amount of a substance supplied by several manufacturers or importers exceeds 1.5 tonnes, even though each supplies <1 tonne. The information required consists of the Sixth Amendment EC Base Set, a description of the... 

The information required for notification of a new chemical substance in Finland corresponds with that of the EC Seventh Amendment . There are limited notifications with different data requirements at below and above 100 kg a (see Table 34.6), full notification at above 1 tonne a (see Table 34.1) and Level 1 and 2 testing (see Tables... 

The information required for a full notification essentially corresponds to the OECD MPD, and is detailed in the Schedule to the Act (Table 34.1). The review period is 90 d. OECD Guidelines are recommended, but equivalent methods are accepted. Tests must be performed in compliance with GLP, and Australian Codes of Practice on GLP are to be... 

Wastes destined for recovery are divided info three categories - the Red, Amber and Green Lists - according to the severity of the hazards they present. Red listed wastes are the most hazardous and are subject to the full notification procedure, i.e. written prior consent of the authorities is required for each waste shipment. For Amber listed wastes, shippers and importers can take advantage of a more streamlined procedure whereby the consent of the competent authorities is assumed provided no objections are made. Green listed wastes are normally not subjected to regulation although shipments should be accompanied by a transfer note. 

Note that you may be covered by the supplier notification rules even If you are not covered by the section 313 release reporting requirements. For example, even if you have less than 10 full-time employees or do not manufacture or process any of the chemicals in sufficient quantities to trigger the release reporting requirements, you may still be required to notify certain customers. 

Characteristic wastes that are decharacterized subsequent to the point of generation (i.e., they become nonhazardous) are handled differently. Once a waste is decharacterized and has met its full LDR treatment standards, it can go to an RCRA nonhazardous waste facility. These LDR notifications and certifications are sent to the U.S. EPA Region or authorized state rather than to the receiving facility. This is intended to protect facilities from the burden of hazardous waste paperwork. 

Priority substances were selected, which are considered to be of particular concern to human health and/or the environment. The suppliers of these priority substances had to provide any missing studies to complete a EU notification Base Set (Table 1). A rapporteur Competent Authority evaluates the full review dossier on behalf of the EU. The final output is a risk assessment (see Section 14), with final recommendations on how to deal with the substance i.e., it may be of no concern, require risk reduction or restriction, or further data may be needed before a decision is made. 

Those who feel that the fact of randomization need not be disclosed to prospective subjects argue that since the alternative treatments to be tested are not known to produce significantly different results and since the physician would have to make an arbitrary selection of one treatment or the other for a particular patient, notification that selection of treatment is by computer rather than by the patient s own physician does not provide additional protection for the subjects and is unnecessary. The response to this contention is that a subject s ability to exercise full autonomy over what will be done with his or her own body is best served by notifying the subject as to how the treatment will be selected and by whom, even if the selection process is equally arbitrary whatever process is used. 

NICNAS. 2,6 Naphthalenedicarboxylic acid. Full Report File No. NA/503, National Indusitrial Chemicals Notification and Assessment Scheme, Commonwealth of Australia, 1997. 

NICNAS (2008) Full Public Report 1,2-Cyclohexanedicarboxylic acid, 1,2-diisononyl ester ( Hexamoll DINCH ). National Industrial Chemicals Notification and Assessment Scheme (NICNAS), File No STD/1259. http //www.nicnas.gov.au/publications/car/new/std/stdfullr/ stdl000fr/stdl259fr.pdf Accessed April 2010... 

The possibility of diversions being facilitated in such ways raises two important issues for competent authorities to address. Firstly, when a pre-export notification appears with the name of a well-known company with a licit requirement for the substance, the notification should not be responded to before actually checking with the company concerned whether it had actually placed the order. Secondly, when such a diversion attempt is detected, full investigations should be launched by the authorities in both the importing and exporting countries to determine how and from whom the order was received. 

The notification procedure of existing active substances, which had started in 2000, was finalized on 31 January 2003. After having succeeded the notification procedure, the names of existing active substances have been published in the Official Journal of the European Communities (OJ). At the next step, the full dossier including aU test reports should be submitted to the Rapporteur Member State in agreed Data Formats including the risk assessment of the active substance. At the last step, the Rapporteur Member State in cooperation with all other Member States will decide whether the active substance wUl be entered onto the positive lists or not. 

To expedite the launch of a new chemical and allow further time to complete the toxicological package for full registration, at first a limited announcement can be filed with a notification time of 30 d. By this procedure, however, not more than 1 t/a of the chemical is allowed to be sold in the EU. 

At the time of the FDA s pre-approval inspection (our first) of the Chemical Development dilevalol DBTA manufacturing operation (dilevalol hydrochloride itself was manufactured in Schering s Ireland facility), Chemical Development received an FDA 483 notification stating that the full-time use of the butanol/water recrystallization process for dilevalol DBTA salt was in violation of the NDA. The NDA stated that the recrystallization process was registered for use only when the first crystallization of the DBTA salt gave a product outside specification the FDA interpreted this to mean no more than about 10% of the time. Since the process had evolved... 

Standard notification For chemicals introduced at >1000 kg/year or for polymers with number average molecular weight (Mn) <1 OOOdaltons. The full set of physicochemical, mammalian toxicity (acute oral, acute dermal, skin and eye irritation, skin sensitisation, mutagenicity, chromosomal aberration, repeat dose toxicity) and aquatic toxicity (acute fish, Daphnia immobilisation, algal toxicity, biodegradation) studies are required 90... 

Notifications or applications for clinical trials are supported by summaries or full reports on the preclinical pharmacology and safety assessment. The kind of safety data (e.g. the type and duration of toxicity tests), which are expected at this time, should correspond to the intended route and duration of application. Data on process details and on the quality of the product are not always required. But it must be kept in mind that clinical trials can only render useful results for the later product registration, if the quality characteristics of the tested product and its method of production are the essentially same as for the final product. If available, clinical data from trials in other countries must also be provided. Protocols for the intended clinical trials are an essential part of the application. 

CROs and site management organizations (SMOs) are organizations that run clinical trials, using physicians who are full-time, part-time or contract employees. The companies employ regulatory staff, for IRB filing, adverse event notification and so on, as well as site coordinators,... 

Chemical manufacturers often supply their products in many markets, and consequently various national chemical control systems have to be complied with. It is prudent to obtain advice on these requirements early in the develc ment stage, to enable infixmed business decisions to be made and to ensure full regulatory compliance. For a new chemical substance, notifications in different countries may be necessary, and it is essential to design the testing programme to fulfil all the various requirements to ensure timely regulatory approvals, and also to minimise the total cost of the studies and the use of animals. 

Substances are classified for labelling by evaluation of their physical, toxicological and ecotoxicological properties. Existing data (eg, from non-GLP and/or non-EC/OECD studies), can be used to classify existing chemical substances and there is no obligation for new testing. For full classification, the Base Set of tests for notification of a new... 

There is no official review period, and the new substance can be imported or manufactured by the notifier as soon as FOEFL has received the notification. However, FOEFL can request further information necessary for full environmental assessment of the substance, or take regulatory action at any time after notification. 

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